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NCT01190930 · CITED IN SOURCE DOCUMENTS

Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2026-05-28

This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization

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outcome · POSTED

DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization

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outcome · POSTED

DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens

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outcome · POSTED

DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care

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outcome · POSTED

Sample Collection of Central Path Review Slides in B-LLy Patients

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outcome · POSTED

Event Free Survival (EFS) for B-LLy Patients

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outcome · POSTED

Overall Survival (OS) for B-LLy Patients

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional

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outcome · POSTED

Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical

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outcome · POSTED

Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: School

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: School

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: School

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School

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outcome · POSTED

Burden of Therapy in Boy AR Patients Overall at End of Therapy: School

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning

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outcome · POSTED

Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning

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outcome · POSTED

Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning

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outcome · POSTED

Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional

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outcome · POSTED

Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional

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outcome · POSTED

Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional

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outcome · POSTED

Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical

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outcome · POSTED

Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical

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outcome · POSTED

Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical

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outcome · POSTED

Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: School

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outcome · POSTED

Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School

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outcome · POSTED

Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: School

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outcome · POSTED

Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning

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outcome · POSTED

Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning

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outcome · POSTED

Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning

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outcome · POSTED

Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right

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outcome · POSTED

Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left

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outcome · POSTED

Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right

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outcome · POSTED

Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left

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outcome · POSTED

Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right

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outcome · POSTED

Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left

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outcome · POSTED

Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right

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outcome · POSTED

Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left

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outcome · POSTED

Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right

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outcome · POSTED

Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932 * Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932 * B-ALL patients must have an initial white blood cell count \< 50,000/uL * Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible * Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met Exclusion Criteria: * With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932 * Patients receiving prior steroid therapy may be eligible for AALL0932 * Patients with central nervous system 3 (CNS3) leukemia * CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy * B-ALL patients with testicular leukemia are not eligible for AALL0932 * For B-LLy patients the following additional exclusion criteria apply: * T-lymphoblastic lymphoma * Morphologically unclassifiable lymphoma * Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma * CNS3-positive disease or testicular involvement * M2 (5% - 25% blasts) or M3 (\> 25% blasts) marrow * Female patients who are pregnant are ineligible * Lactating females are not eligible unless they have agreed not to breastfeed their infants * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained * Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
healthy Volunteers
false
maximum Age
30 Years
minimum Age
1 Year
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
    intervention Names
    1. Drug: Dexamethasone
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Mercaptopurine
    4. Drug: Methotrexate
    5. Other: Quality-of-Life Assessment
    6. Other: Questionnaire Administration
    7. Drug: Vincristine Sulfate
    label
    Arm A (risk-adapted chemotherapy)
    type
    EXPERIMENTAL
  2. description
    Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
    intervention Names
    1. Drug: Dexamethasone
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Mercaptopurine
    4. Drug: Methotrexate
    5. Other: Quality-of-Life Assessment
    6. Other: Questionnaire Administration
    7. Drug: Vincristine Sulfate
    label
    Arm B (risk-adapted chemotherapy)
    type
    EXPERIMENTAL
  3. description
    See Detailed Description.
    intervention Names
    1. Drug: Cyclophosphamide
    2. Drug: Cytarabine
    3. Drug: Dexamethasone
    4. Drug: Doxorubicin Hydrochloride
    5. Other: Laboratory Biomarker Analysis
    6. Drug: Leucovorin Calcium
    7. Drug: Mercaptopurine
    8. Drug: Methotrexate
    9. Drug: Pegaspargase
    10. Other: Quality-of-Life Assessment
    11. Other: Questionnaire Administration
    12. Drug: Thioguanine
    label
    Arm B-LLy (4-week cycle maintenance)
    type
    EXPERIMENTAL
  4. description
    Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
    intervention Names
    1. Drug: Dexamethasone
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Mercaptopurine
    4. Drug: Methotrexate
    5. Other: Quality-of-Life Assessment
    6. Other: Questionnaire Administration
    7. Drug: Vincristine Sulfate
    label
    Arm C (risk-adapted chemotherapy)
    type
    EXPERIMENTAL
  5. description
    Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
    intervention Names
    1. Drug: Dexamethasone
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Mercaptopurine
    4. Drug: Methotrexate
    5. Other: Quality-of-Life Assessment
    6. Other: Questionnaire Administration
    7. Drug: Vincristine Sulfate
    label
    Arm D (risk-adapted chemotherapy)
    type
    EXPERIMENTAL
  6. description
    Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
    intervention Names
    1. Drug: Cyclophosphamide
    2. Drug: Cytarabine
    3. Drug: Dexamethasone
    4. Drug: Doxorubicin Hydrochloride
    5. Other: Laboratory Biomarker Analysis
    6. Drug: Mercaptopurine
    7. Drug: Methotrexate
    8. Drug: Pegaspargase
    9. Other: Quality-of-Life Assessment
    10. Other: Questionnaire Administration
    11. Drug: Thioguanine
    12. Drug: Vincristine Sulfate
    label
    Arm LR-C (risk-adapted chemotherapy)
    type
    EXPERIMENTAL
  7. description
    Patients receive consolidation and maintenance therapy. See detailed description.
    intervention Names
    1. Drug: Dexamethasone
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Leucovorin Calcium
    4. Drug: Mercaptopurine
    5. Drug: Methotrexate
    6. Other: Quality-of-Life Assessment
    7. Other: Questionnaire Administration
    8. Drug: Vincristine Sulfate
    label
    Arm LR-M (risk-adapted chemotherapy)
    type
    EXPERIMENTAL
  8. description
    See Detailed Description
    intervention Names
    1. Drug: Cyclophosphamide
    2. Drug: Cytarabine
    3. Drug: Dexamethasone
    4. Drug: Doxorubicin Hydrochloride
    5. Other: Laboratory Biomarker Analysis
    6. Drug: Leucovorin Calcium
    7. Drug: Mercaptopurine
    8. Drug: Methotrexate
    9. Drug: Pegaspargase
    10. Other: Quality-of-Life Assessment
    11. Other: Questionnaire Administration
    12. Drug: Thioguanine
    label
    Arm SR DS (12-week cycle maintenance)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm B-LLy (4-week cycle maintenance)
    2. Arm LR-C (risk-adapted chemotherapy)
    3. Arm SR DS (12-week cycle maintenance)
    description
    Given IV
    name
    Cyclophosphamide
    other Names
    1. (-)-Cyclophosphamide
    2. 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
    3. Asta B 518
    4. B 518
    5. B-518
    6. B518
    7. Carloxan
    8. Ciclofosfamida
    9. Ciclofosfamide
    10. Cicloxal
    11. Clafen
    12. Claphene
    type
    DRUG
  2. arm Group Labels
    1. Arm B-LLy (4-week cycle maintenance)
    2. Arm LR-C (risk-adapted chemotherapy)
    3. Arm SR DS (12-week cycle maintenance)
    description
    Given IT, IV, or SC
    name
    Cytarabine
    other Names
    1. .beta.-Cytosine arabinoside
    2. 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
    3. 1-.beta.-D-Arabinofuranosylcytosine
    4. 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
    5. 1-Beta-D-arabinofuranosylcytosine
    6. 1.beta.-D-Arabinofuranosylcytosine
    7. 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
    8. 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
    9. Alexan
    10. Ara-C
    11. ARA-cell
    12. Arabine
    type
    DRUG
  3. arm Group Labels
    1. Arm A (risk-adapted chemotherapy)
    2. Arm B (risk-adapted chemotherapy)
    3. Arm B-LLy (4-week cycle maintenance)
    4. Arm C (risk-adapted chemotherapy)
    5. Arm D (risk-adapted chemotherapy)
    6. Arm LR-C (risk-adapted chemotherapy)
    7. Arm LR-M (risk-adapted chemotherapy)
    8. Arm SR DS (12-week cycle maintenance)
    description
    Given orally (PO) or IV
    name
    Dexamethasone
    other Names
    1. Aacidexam
    2. Adexone
    3. Aknichthol Dexa
    4. Alba-Dex
    5. Alin
    6. Alin Depot
    7. Alin Oftalmico
    8. Amplidermis
    9. Anemul mono
    10. Auricularum
    11. Auxiloson
    12. Baycadron
    type
    DRUG
  4. arm Group Labels
    1. Arm B-LLy (4-week cycle maintenance)
    2. Arm LR-C (risk-adapted chemotherapy)
    3. Arm SR DS (12-week cycle maintenance)
    description
    Given IV
    name
    Doxorubicin Hydrochloride
    other Names
    1. 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
    2. ADM
    3. Adriacin
    4. Adriamycin
    5. Adriamycin Hydrochloride
    6. Adriamycin PFS
    7. Adriamycin RDF
    8. ADRIAMYCIN, HYDROCHLORIDE
    9. Adriamycine
    10. Adriblastina
    11. Adriblastine
    12. Adrimedac
    type
    DRUG
  5. arm Group Labels
    1. Arm A (risk-adapted chemotherapy)
    2. Arm B (risk-adapted chemotherapy)
    3. Arm B-LLy (4-week cycle maintenance)
    4. Arm C (risk-adapted chemotherapy)
    5. Arm D (risk-adapted chemotherapy)
    6. Arm LR-C (risk-adapted chemotherapy)
    7. Arm LR-M (risk-adapted chemotherapy)
    8. Arm SR DS (12-week cycle maintenance)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  6. arm Group Labels
    1. Arm B-LLy (4-week cycle maintenance)
    2. Arm LR-M (risk-adapted chemotherapy)
    3. Arm SR DS (12-week cycle maintenance)
    description
    Given PO
    name
    Leucovorin Calcium
    other Names
    1. Adinepar
    2. Calcifolin
    3. Calcium (6S)-Folinate
    4. Calcium Folinate
    5. Calcium Leucovorin
    6. Calfolex
    7. Calinat
    8. Cehafolin
    9. Citofolin
    10. Citrec
    11. Citrovorum Factor
    12. Cromatonbic Folinico
    type
    DRUG
  7. arm Group Labels
    1. Arm A (risk-adapted chemotherapy)
    2. Arm B (risk-adapted chemotherapy)
    3. Arm B-LLy (4-week cycle maintenance)
    4. Arm C (risk-adapted chemotherapy)
    5. Arm D (risk-adapted chemotherapy)
    6. Arm LR-C (risk-adapted chemotherapy)
    7. Arm LR-M (risk-adapted chemotherapy)
    8. Arm SR DS (12-week cycle maintenance)
    description
    Given PO
    name
    Mercaptopurine
    other Names
    1. 3H-Purine-6-thiol
    2. 6 MP
    3. 6 Thiohypoxanthine
    4. 6 Thiopurine
    5. 6-Mercaptopurine
    6. 6-Mercaptopurine Monohydrate
    7. 6-MP
    8. 6-Purinethiol
    9. 6-Thiopurine
    10. 6-Thioxopurine
    11. 6H-Purine-6-thione, 1,7-dihydro- (9CI)
    12. 7-Mercapto-1,3,4,6-tetrazaindene
    type
    DRUG
  8. arm Group Labels
    1. Arm A (risk-adapted chemotherapy)
    2. Arm B (risk-adapted chemotherapy)
    3. Arm B-LLy (4-week cycle maintenance)
    4. Arm C (risk-adapted chemotherapy)
    5. Arm D (risk-adapted chemotherapy)
    6. Arm LR-C (risk-adapted chemotherapy)
    7. Arm LR-M (risk-adapted chemotherapy)
    8. Arm SR DS (12-week cycle maintenance)
    description
    Given IT, PO, or IV
    name
    Methotrexate
    other Names
    1. Abitrexate
    2. Alpha-Methopterin
    3. Amethopterin
    4. Brimexate
    5. CL 14377
    6. CL-14377
    7. Emtexate
    8. Emthexat
    9. Emthexate
    10. Farmitrexat
    11. Fauldexato
    12. Folex
    type
    DRUG
  9. arm Group Labels
    1. Arm B-LLy (4-week cycle maintenance)
    2. Arm LR-C (risk-adapted chemotherapy)
    3. Arm SR DS (12-week cycle maintenance)
    description
    Given IV
    name
    Pegaspargase
    other Names
    1. L-Asparaginase with Polyethylene Glycol
    2. Oncaspar
    3. Oncaspar-IV
    4. PEG-Asparaginase
    5. PEG-L-Asparaginase
    6. PEG-L-Asparaginase (Enzon - Kyowa Hakko)
    7. PEGLA
    8. Polyethylene Glycol L-Asparaginase
    9. Polyethylene Glycol-L-Asparaginase
    type
    DRUG
  10. arm Group Labels
    1. Arm A (risk-adapted chemotherapy)
    2. Arm B (risk-adapted chemotherapy)
    3. Arm B-LLy (4-week cycle maintenance)
    4. Arm C (risk-adapted chemotherapy)
    5. Arm D (risk-adapted chemotherapy)
    6. Arm LR-C (risk-adapted chemotherapy)
    7. Arm LR-M (risk-adapted chemotherapy)
    8. Arm SR DS (12-week cycle maintenance)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
  11. arm Group Labels
    1. Arm A (risk-adapted chemotherapy)
    2. Arm B (risk-adapted chemotherapy)
    3. Arm B-LLy (4-week cycle maintenance)
    4. Arm C (risk-adapted chemotherapy)
    5. Arm D (risk-adapted chemotherapy)
    6. Arm LR-C (risk-adapted chemotherapy)
    7. Arm LR-M (risk-adapted chemotherapy)
    8. Arm SR DS (12-week cycle maintenance)
    description
    Ancillary studies
    name
    Questionnaire Administration
    type
    OTHER
  12. arm Group Labels
    1. Arm B-LLy (4-week cycle maintenance)
    2. Arm LR-C (risk-adapted chemotherapy)
    3. Arm SR DS (12-week cycle maintenance)
    description
    Given PO
    name
    Thioguanine
    other Names
    1. 2-Amino 6MP
    2. 2-Amino-1,7-dihydro-6H-purine-6-thione
    3. 2-Amino-6-mercaptopurine
    4. 2-Amino-6-purinethiol
    5. 2-Aminopurin-6-thiol
    6. 2-Aminopurine-6(1H)-thione
    7. 2-Aminopurine-6-thiol
    8. 2-Aminopurine-6-thiol Hemihydrate
    9. 2-Mercapto-6-aminopurine
    10. 6-Amino-2-mercaptopurine
    11. 6-Mercapto-2-aminopurine
    12. 6-Mercaptoguanine
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
9350
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
    measure
    Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization
    time Frame
    5.7 years
  2. description
    DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
    measure
    DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization
    time Frame
    5.7 years
  3. description
    DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
    measure
    DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens
    time Frame
    5.1 years
  4. description
    DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. The 5-year DFS and 95% confidence interval for these patients will be estimated.
    measure
    DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care
    time Frame
    5.1 years
  5. description
    Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported.
    measure
    Sample Collection of Central Path Review Slides in B-LLy Patients
    time Frame
    Up to 1 month
  6. description
    EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact. The 5-year EFS and 95% confidence interval for these patients will be estimated.
    measure
    Event Free Survival (EFS) for B-LLy Patients
    time Frame
    5 years
  7. description
    OS is calculated as the time from study enrollment to death or date of last contact. The 5-year OS and 95% confidence interval for these patients will be estimated.
    measure
    Overall Survival (OS) for B-LLy Patients
    time Frame
    5 years
secondary Outcomes
  1. description
    Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
    measure
    Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional
    time Frame
    2 Months
  2. description
    Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
    measure
    Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional
    time Frame
    1 year
  3. description
    Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
    measure
    Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional
    time Frame
    1.7 years
  4. description
    Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
    measure
    Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
    time Frame
    2.5 years
  5. description
    Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Genetic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
    measure
    Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional
    time Frame
    3.2 years
  6. description
    Age and gender standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
    measure
    Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
    time Frame
    2 Months
  7. description
    Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
    measure
    Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical
    time Frame
    1 Year
  8. description
    Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
    measure
    Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical
    time Frame
    1.7 years
  9. description
    Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
    measure
    Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
    time Frame
    2.4 Years
  10. description
    Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
    measure
    Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical
    time Frame
    3.2 years
  11. description
    Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
    measure
    Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: School
    time Frame
    2 Months
  12. description
    Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
    measure
    Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: School
    time Frame
    1 Year
Full study description
brief Summary
This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.
detailed Description
PRIMARY OBJECTIVES: l. To determine if a maintenance regimen containing weekly oral methotrexate at 40 mg/m\^2/week will result in an improved disease free survival (DFS) compared to that containing weekly oral methotrexate at 20 mg/m\^2/week in the average-risk (AR) subset of patients with standard-risk B-precursor acute lymphoblastic leukemia (ALL). (Complete effective January 13, 2017) II. To determine whether a reduced-pulses maintenance regimen with vincristine (vincristine sulfate)/dexamethasone pulses delivered every 12 weeks can be used without adversely impacting DFS as compared to pulses given every 4 weeks in the AR subset of patients with standard risk B-precursor ALL. III. To confirm that patients in the low-risk (LR) subset of standard risk B-precursor ALL, based on clinical and cytogenetic features and minimal residual disease (MRD) criteria, can attain a 5 year DFS of at least 95% with either a P9904 based regimen that includes 6 courses of intermediate dose (1 g/m\^2 over 24 hours) methotrexate without alkylating agents or anthracyclines (Arm LR-M), or an outpatient based regimen identical to that of AR patients with reduced vincristine/dexamethasone pulses at 12 week intervals during maintenance (Arm LR-C). IV. To provide standardized treatment and enhanced supportive care to children with standard-risk (SR) Down syndrome B-ALL in order to improve outcomes and facilitate further study of this biologically and clinically unique patient subgroup. V. To improve understanding of the biology of localized B-lineage lymphoblastic lymphoma (B-LLy) and Down syndrome (DS) B-LLy by obtaining biologic data, including fluorescence in situ hybridization (FISH) for recurrent cytogenetic lesions on paraffin specimen, and banking tissue for future research. VI. To describe the 5-year event free survival (EFS) and overall survival (OS) of patients with Murphy stage I and II B-LLy receiving modified AR B-ALL therapy. SECONDARY OBJECTIVES: I. To assess the burden of AR B-ALL therapy as measured by surveys of the child's quality of life, missed days of school/daycare/work by children and parents, family functioning, parental perception of the child's health vulnerability, physical functioning, and emotional distress, 1) overall at different time points during and at the end of therapy, and by 2) comparing children randomized to every 4 week vs. every 12 week dexamethasone/vincristine pulses during maintenance. (Closed to accrual as of April 19, 2013) II. To characterize the onset, severity, and natural history of vincristine associated neuropathy by physical therapists (or occupational therapists) in children undergoing therapy for AR B-ALL, 1) overall at different time points during and at the end of therapy, and by 2) comparing children randomized to every 4 week vs. every 12 week dexamethasone/vincristine pulses during maintenance. (Closed to accrual as of March 15, 2013) TERTIARY OBJECTIVES: I. To explore the correlation of minimal marrow disease (MMD) at diagnosis and outcome for patients with B-LLy. (Closed effective Amendment #5) OUTLINE: All patients receive induction therapy comprising intrathecal (IT) cytarabine on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) or IV twice daily (BID) on days 1-28; pegaspargase IV over 1-2 hours on day 4; and IT methotrexate\* on days 8 and 29. Patients with Philadelphia chromosome-positive disease are eligible to transfer to COG-AALL0622 by day 15 of induction therapy and patients with high-risk (HR) or very high-risk (VHR) disease are eligible to transfer to a COG HR or VHR trial at the end of induction therapy. Patients with standard-risk disease with Down syndrome (DS) who have bone marrow minimal residual disease 0.01% are eligible to transfer to the DS stratum of the HR trial. Patients with induction failure (defined as M3 \[\> 25% lymphoblasts\] on day 29) may be eligible for the COG VHR-acute lymphoblastic leukemia study. NOTE: \*Patients with DS also receive oral leucovorin calcium every 12 hours on days 10-11 and 31-32. STANDARD-RISK WITH DOWN SYNDROME: Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; mercaptopurine PO on days 1-28; IT methotrexate on days 1, 8, and 15; and leucovorin calcium PO every 12 hours on days 3-4, 10-11, and 17-18. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on day 31; and leucovorin calcium PO every 12 hours on days 36-34. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 29-32 and 33-39; IT methotrexate on days 1 and 29; and leucovorin calcium PO every 12 hours on days 3-4 and 31-32. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on days 1 and 31; and leucovorin calcium PO every 12 hours on days 3-4 and 33-34. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Courses repeat every 12 weeks for 2 years (timed from the start of interim maintenance I therapy). B-LLy: Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; mercaptopurine PO on days 1-28; IT methotrexate on days 1, 8, and 15; and leucovorin calcium PO every 12 hours on days 3-4, 10-11, and 17-18. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on day 31; and leucovorin calcium PO every 12 hours on days 36-34. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 29-32 and 33-39; IT methotrexate on days 1 and 29; and leucovorin calcium PO every 12 hours on days 3-4 and 31-32. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on days 1 and 31; and leucovorin calcium PO every 12 hours on days 3-4 and 33-34. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Courses repeat every 4 weeks for 2 years (timed from the start of interim maintenance I therapy). AVERAGE-RISK: Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; mercaptopurine PO on days 1-28; and IT methotrexate on days 1, 8, and 15.Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on day 31. Delayed intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and IT methotrexate on days 1 and 29. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on days 1 and 31. Maintenance therapy: Patients are randomized to 1 of 4 maintenance therapy treatment arms. Arm A: Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Arm B: Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Arm C: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Arm D: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. In all arms, maintenance therapy courses repeat every 12 weeks for 2 years for girls and for 3 years for boys (timed from the start of interim maintenance I therapy). LOW-RISK: Patients are randomized to 1 of 2 treatment arms. Arm I (LR-M): Consolidation therapy (19 weeks): Beginning one week after completion of induction therapy, patients receive vincristine sulfate IV on days 15, 22, 78, and 85; methotrexate IV over 24 hours and IT methotrexate on days 8, 29, 50, 71, 92, and 113; leucovorin calcium PO or IV on days 9-10, 30-31, 51-52, 72-73, 93-94, and 114-115; dexamethasone PO BID or IV on days 15-21 and 78-84; and PO mercaptopurine on days 1-133.Maintenance therapy: Patients receive vincristine sulfate IV on days 1 and 8; dexamethasone PO BID on days 1-7; methotrexate\* PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, and 106; and mercaptopurine PO on days 1-112. Courses repeat every 16 weeks. Patients also receive IT methotrexate on days 1 and 85 (courses 1 and 4), day 57 (courses 2 and 5), or day 29 (courses 3 and 6). Patients then receive course 7 comprising vincristine sulfate IV on days 1 and 8; dexamethasone PO BID on days 1-7; methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64; and mercaptopurine PO on days 1-70. Treatment continues for 2 and ½ years (timed from the date of diagnosis).NOTE: \*Patients do not receive methotrexate PO on the days that they receive IT methotrexate. Arm II (LR-C): Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; oral mercaptopurine on days 1-28; and IT methotrexate on days 1, 8, and 15. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on day 31. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and IT methotrexate on days 1 and 29.Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on days 1 and 31. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Courses repeat every 12 weeks for 2 years for girls and for 3 years for boys (timed from the start of interim maintenance I therapy). After completion of study treatment, patients are followed up periodically for 10 years from study entry.
Source references
avail Ipds
  1. comment
    Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
    type
    Individual Participant Data Set
references
  1. citation
    Chen W, Chang TC, Rabin KR, Raetz EA, Devidas M, Hunger SP, Ramirez NC, Mullighan CG, Loh ML, Wu G. Performance of Two-Phase Designs for the Time-to-Event Outcome and a Case Study Assessing the Relapse Risk Associated With B-ALL Subtypes. JCO Clin Cancer Inform. 2025 May;9:e2400223. doi: 10.1200/CCI-24-00223. Epub 2025 May 2.
    pmid
    40315406
    type
    DERIVED
  2. citation
    Chang TC, Chen W, Qu C, Cheng Z, Hedges D, Elsayed A, Pounds SB, Shago M, Rabin KR, Raetz EA, Devidas M, Cheng C, Angiolillo A, Baviskar P, Borowitz M, Burke MJ, Carroll A, Carroll WL, Chen IM, Harvey R, Heerema N, Iacobucci I, Wang JR, Jeha S, Larsen E, Mattano L, Maloney K, Pui CH, Ramirez NC, Salzer W, Willman C, Winick N, Wood B, Hunger SP, Wu G, Mullighan CG, Loh ML. Genomic Determinants of Outcome in Acute Lymphoblastic Leukemia. J Clin Oncol. 2024 Oct 10;42(29):3491-3503. doi: 10.1200/JCO.23.02238. Epub 2024 Aug 9.
    pmid
    39121442
    type
    DERIVED
  3. citation
    Rabin KR, Devidas M, Chen Z, Ji L, Kairalla J, Hitzler JK, Yang JJ, Carroll AJ, Heerema NA, Borowitz MJ, Wood BL, Roberts KG, Mullighan CG, Harvey RC, Chen IM, Willman CL, Reshmi SC, Gastier-Foster JM, Bhojwani D, Rheingold SR, Maloney KW, Mattano LA, Larsen EC, Schore RJ, Burke MJ, Salzer WL, Winick NJ, Carroll WL, Raetz EA, Loh ML, Hunger SP, Angiolillo AL. Outcomes in Children, Adolescents, and Young Adults With Down Syndrome and ALL: A Report From the Children's Oncology Group. J Clin Oncol. 2024 Jan 10;42(2):218-227. doi: 10.1200/JCO.23.00389. Epub 2023 Oct 27.
    pmid
    37890117
    type
    DERIVED
  4. citation
    Angiolillo AL, Schore RJ, Kairalla JA, Devidas M, Rabin KR, Zweidler-McKay P, Borowitz MJ, Wood B, Carroll AJ, Heerema NA, Relling MV, Hitzler J, Lane AR, Maloney KW, Wang C, Bassal M, Carroll WL, Winick NJ, Raetz EA, Loh ML, Hunger SP. Excellent Outcomes With Reduced Frequency of Vincristine and Dexamethasone Pulses in Standard-Risk B-Lymphoblastic Leukemia: Results From Children's Oncology Group AALL0932. J Clin Oncol. 2021 May 1;39(13):1437-1447. doi: 10.1200/JCO.20.00494. Epub 2021 Jan 7.
    pmid
    33411585
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      1. context exact
        cause of the increased toxicity of thioguanine, mercaptopurine remains the standard drug of choice.</li></ul></div></li><li>In the COG <a href="/clinicaltrials/NCT01190930">AALL0932 (NCT01190930)</a> trial, NCI standard-risk patients with average-risk features were randomly assigned to receive weekly oral methotrexate during main
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        toxicity of thioguanine, mercaptopurine remains the standard drug of choice.</li></ul></div></li><li>In the COG <a href="/clinicaltrials/NCT01190930">AALL0932 (NCT01190930)</a> trial, NCI standard-risk patients with average-risk features were randomly assigned to receive weekly oral methotrexate during maintenance at one of two s
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        ','CDR0000810017&amp;version=HealthProfessional&amp;language=English'); return(false);">Level of evidence A1</a>] </li><li>In the COG <a href="/clinicaltrials/NCT01190930">AALL0932 (NCT01190930)</a> trial, standard-risk patients were randomly assigned during maintenance to receive vincristine/dexamethasone pulses every 4 weeks o
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        rsion=HealthProfessional&amp;language=English'); return(false);">Level of evidence A1</a>] </li><li>In the COG <a href="/clinicaltrials/NCT01190930">AALL0932 (NCT01190930)</a> trial, standard-risk patients were randomly assigned during maintenance to receive vincristine/dexamethasone pulses every 4 weeks or every 12 weeks.[<a hr
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      source update dates
      1. context
        Updated: April 21, 2025
        datetime
        2025-04-21T12:00:00Z
        display
        April 21, 2025

    Preserved source evidence · Not medical advice