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NCT00075725 · CITED IN SOURCE DOCUMENTS

Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

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
2021-04-27

This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.

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

Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions

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outcome · POSTED

Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)

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outcome · POSTED

Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).

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outcome · POSTED

Correlation of Early Marrow Response Status With MRD Positive.

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outcome · POSTED

Correlation of Early Marrow Response Status With MRD Negative.

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outcome · POSTED

Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)

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outcome · POSTED

Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).

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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: * Must be eligible for and enrolled on classification study COG-AALL03B1 * Newly diagnosed B-precursor acute lymphoblastic leukemia * WBC \> 50,000/mm\^3 for patients age 1 to 9 * Any WBC for patients age 10 to 30 OR patients who have received prior steroid therapy OR patients with testicular disease * Whit blood cell (WBC) criteria: * Age 1 - 9 years: WBC \>= 50,000/uL * Age 10 - 30 years: any WBC * Prior steroid therapy: any WBC * Testicular disease: any WBC * Patients shall have had no other prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine * Patients receiving prior steroid therapy (as described in AALL03B1) are eligible for study; the dose and duration of previous steroid therapy should be carefully documented * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: * Patients with Down syndrome are ineligible to enroll onto this study
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 in arm I receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.
    intervention Names
    1. Drug: Cyclophosphamide
    2. Drug: Cytarabine
    3. Drug: Daunorubicin Hydrochloride
    4. Drug: Dexamethasone
    5. Drug: Doxorubicin Hydrochloride
    6. Drug: Mercaptopurine
    7. Drug: Methotrexate
    8. Drug: Pegaspargase
    9. Radiation: Radiation Therapy
    10. Drug: Thioguanine
    11. Drug: Vincristine Sulfate
    label
    Arm I
    type
    ACTIVE_COMPARATOR
  2. description
    Patients in arm II will receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.
    intervention Names
    1. Drug: Cyclophosphamide
    2. Drug: Cytarabine
    3. Drug: Daunorubicin Hydrochloride
    4. Drug: Dexamethasone
    5. Drug: Doxorubicin Hydrochloride
    6. Drug: Leucovorin Calcium
    7. Drug: Mercaptopurine
    8. Drug: Methotrexate
    9. Drug: Pegaspargase
    10. Radiation: Radiation Therapy
    11. Drug: Thioguanine
    12. Drug: Vincristine Sulfate
    label
    Arm II
    type
    ACTIVE_COMPARATOR
  3. description
    Patients in arm III will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    intervention Names
    1. Drug: Cyclophosphamide
    2. Drug: Cytarabine
    3. Drug: Daunorubicin Hydrochloride
    4. Drug: Dexamethasone
    5. Drug: Doxorubicin Hydrochloride
    6. Drug: Mercaptopurine
    7. Drug: Methotrexate
    8. Drug: Pegaspargase
    9. Drug: Prednisone
    10. Radiation: Radiation Therapy
    11. Drug: Thioguanine
    12. Drug: Vincristine Sulfate
    label
    Arm III
    type
    EXPERIMENTAL
  4. description
    Patients in arm IV will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    intervention Names
    1. Drug: Cyclophosphamide
    2. Drug: Cytarabine
    3. Drug: Daunorubicin Hydrochloride
    4. Drug: Dexamethasone
    5. Drug: Doxorubicin Hydrochloride
    6. Drug: Leucovorin Calcium
    7. Drug: Mercaptopurine
    8. Drug: Methotrexate
    9. Drug: Pegaspargase
    10. Drug: Prednisone
    11. Radiation: Radiation Therapy
    12. Drug: Thioguanine
    label
    Arm IV
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I
    2. Arm II
    3. Arm III
    4. Arm IV
    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. Carloxan
    4. Ciclofosfamida
    5. Ciclofosfamide
    6. Cicloxal
    7. Clafen
    8. Claphene
    9. CP monohydrate
    10. CTX
    11. CYCLO-cell
    12. Cycloblastin
    type
    DRUG
  2. arm Group Labels
    1. Arm I
    2. Arm II
    3. Arm III
    4. Arm IV
    description
    Given IT, SC, or IV
    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 I
    2. Arm II
    3. Arm III
    4. Arm IV
    description
    Given IV
    name
    Daunorubicin Hydrochloride
    other Names
    1. Cerubidin
    2. Cerubidine
    3. Cloridrato de Daunorubicina
    4. Daunoblastin
    5. Daunoblastina
    6. Daunoblastine
    7. Daunomycin Hydrochloride
    8. Daunomycin, hydrochloride
    9. Daunorubicin.HCl
    10. Daunorubicini Hydrochloridum
    11. FI-6339
    12. Ondena
    type
    DRUG
  4. arm Group Labels
    1. Arm I
    2. Arm II
    3. Arm III
    4. Arm IV
    description
    Given 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
  5. arm Group Labels
    1. Arm I
    2. Arm II
    3. Arm III
    4. Arm IV
    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
  6. arm Group Labels
    1. Arm II
    2. Arm IV
    description
    Given IV
    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 I
    2. Arm II
    3. Arm III
    4. Arm IV
    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 I
    2. Arm II
    3. Arm III
    4. Arm IV
    description
    Given IT 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 I
    2. Arm II
    3. Arm III
    4. Arm IV
    description
    Given IM
    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 III
    2. Arm IV
    description
    Given PO or IV
    name
    Prednisone
    other Names
    1. .delta.1-Cortisone
    2. 1, 2-Dehydrocortisone
    3. Adasone
    4. Cortancyl
    5. Dacortin
    6. DeCortin
    7. Decortisyl
    8. Decorton
    9. Delta 1-Cortisone
    10. Delta-Dome
    11. Deltacortene
    12. Deltacortisone
    type
    DRUG
  11. arm Group Labels
    1. Arm I
    2. Arm II
    3. Arm III
    4. Arm IV
    description
    Undergo radiation therapy
    name
    Radiation Therapy
    other Names
    1. Cancer Radiotherapy
    2. ENERGY_TYPE
    3. Irradiate
    4. Irradiated
    5. Irradiation
    6. Radiation
    7. Radiation Therapy, NOS
    8. Radiotherapeutics
    9. Radiotherapy
    10. RT
    11. Therapy, Radiation
    type
    RADIATION
  12. arm Group Labels
    1. Arm I
    2. Arm II
    3. Arm III
    4. Arm IV
    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
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
3154
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Event Free Probability.
    measure
    Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions
    time Frame
    5 years
secondary Outcomes
  1. description
    Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells, and negative with \< 0.1 detectable leukemia cells.
    measure
    Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)
    time Frame
    5 Years
  2. description
    Bone marrow MRD status is defined as negative with \< .01 detectable leukemia cells.
    measure
    Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).
    time Frame
    5 years
  3. description
    Bone marrow status is defined as: M1: \< 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: \> 25% lymphoblasts. Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells, and negative with \< 0.1 detectable leukemia cells.
    measure
    Correlation of Early Marrow Response Status With MRD Positive.
    time Frame
    Day 29
  4. description
    Bone marrow status is defined as: M1: \< 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: \> 25% lymphoblasts. Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells, and negative with \< 0.1 detectable leukemia cells.
    measure
    Correlation of Early Marrow Response Status With MRD Negative.
    time Frame
    Day 29
  5. description
    Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells.
    measure
    Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)
    time Frame
    5 years
  6. description
    Bone marrow MRD status is defined as negative with \< 0.1 detectable leukemia cells.
    measure
    Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).
    time Frame
    5 years
Full study description
brief Summary
This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
detailed Description
OBJECTIVES: I. Improve the outcome of children with high-risk acute lymphoblastic leukemia treated with 2 different chemotherapy regimens. II. Determine the relative safety and efficacy of dexamethasone given for 14 days vs prednisone given for 28 days during induction. III. Determine the relative safety and efficacy of high-dose methotrexate (5gm/m\^2) with leucovorin rescue compared to escalating methotrexate without leucovorin rescue (Capizzi I) during interim maintenance I. IV. Correlate Day 29 minimal residual disease (MRD) with event-free survival (EFS) and overall survival (OS). V. Correlate early marrow response status with day-29 MRD status. VI. Improve outcome by identifying additional high risk patients by Day 29 MRD for treatment with fully augmented Berlin-Frankfurt-Munster (BFM). OUTLINE: This is a randomized, multicenter study. Patients are stratified according to early response (slow early response \[SER\] vs rapid early response \[RER\]). Induction therapy: Patients are randomized to 1 of 4 treatment arms. ARM I: Patients receive cytarabine intrathecally (IT) on day 1, vincristine intravenously (IV) and daunorubicin IV on days 1, 8, 15, and 22, dexamethasone orally (PO) or IV twice daily (BID) on days 1-14, methotrexate (MTX) IT on days 8 and 29\* and pegaspargase intramuscularly (IM) once on day 4, 5, or 6. NOTE: \*Patients with CNS3 disease (WBC \> 5/mL in cerebrospinal fluid and positive for blasts on cytospin) also receive MTX IT on days 15 and 22. ARM II: Patients receive induction therapy as in Arm I. ARM III: Patients receive cytarabine, vincristine, daunorubicin, and pegaspargase as in Arm I. Patients also receive prednisone PO or IV BID on days 1-28 and MTX IT on days 8 and 29. ARM IV: Patients receive induction therapy as in Arm III. Patients in all arms are evaluated at day 29 of induction therapy. Patients with M3 disease are removed from study. Patients with M1 disease and less than 1% minimal residual disease (MRD) proceed to consolidation therapy beginning on day 36. Patients with M2 disease OR with MI disease and at least 1% MRD receive extended induction therapy for 2 additional weeks. Patients with SER disease and MLL rearrangements are removed from the study but may be eligible for treatment on protocol COG-AALL0031. Extended induction therapy: Patients continue to receive therapy on the arm to which they were originally randomized. ARMS I and II: Patients receive dexamethasone PO or IV BID on days 1-14, vincristine IV on days 1 and 8, daunorubicin IV on day 1 and pegaspargase IM on day 4, 5, or 6 and are then reevaluated. ARMS III and IV: Patients receive prednisone PO or IV BID on days 1-14, and vincristine, daunorubicin, and pegaspargase as in Arms I and II and are then reevaluated. Patients on all arms who have M1 disease and less than 1% MRD after extended induction proceed to consolidation therapy and continue as SER patients. All other patients are removed from study. Consolidation therapy: All patients receive cyclophosphamide IV over 30 minutes on days 1 and 29, cytarabine IV or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine (MP) PO on days 1-14 and 29-42, vincristine IV on days 15, 22, 43, and 50; pegaspargase IM on days 15 and 43 and MTX\* IT on days 1, 8, 15, and 22. Patients with testicular disease also receive radiotherapy to the testes. NOTE: \*Patients with CNS3 disease receive MTX on days 1 and 8 only. Interim maintenance therapy I: Patients continue to receive treatment on the arm to which they were originally randomized. ARM I: (escalating-dose MTX) Patients receive vincristine IV and escalating-dose MTX IV on days 1, 11, 21, 31, and 41, pegaspargase IM on days 2 and 22 and MTX IT on days 1 and 21. ARM II: (high-dose MTX) Patients receive vincristine IV and high-dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, MP PO on days 1-56 and IT MTX on days 1 and 29. Patients also receive leucovorin calcium IV every 6 hours for at least 3 doses, beginning 42 hours after start of each MTX infusion. ARM III: (escalating-dose MTX) Patients receive interim maintenance I therapy as in Arm I. ARM IV: (high-dose MTX) Patients receive interim maintenance I therapy as in Arm II. DELAYED INTENSIFICATION THERAPY I: All patients receive vincristine IV on days 1, 8, 15, 43, and 50, dexamethasone PO or IV BID on days 1 to 21 for patients age 1 to 12 OR on days 1-7 and 15-21 for patients age 13 and over, doxorubicin IV on days 1, 8, and 15, pegaspargase IM on day 4, 5, or 6 AND day 43, cyclophosphamide IV over 30 minutes on day 29, cytarabine IV or SC on days 30-33 and 37-40, thioguanine PO on days 29-42 and MTX IT on days 1, 29, and 36.After delayed intensification I, SER patients proceed to interim maintenance II and delayed intensification II. RER patients proceed directly to maintenance. INTERIM MAINTENANCE THERAPY II: All patients receive vincristine IV and MTX IV on days 1, 11, 21, 31, and 41, pegaspargase IM on days 2 and 22; and MTX IT on days 1 and 21. Patients then proceed to delayed intensification II. DELAYED INTENSIFICATION THERAPY II: All patients receive therapy as in delayed intensification I, arm I. CNS3 patients also receive radiotherapy for 3-10 days, beginning on day 29. All other SER patients, patients with MLL rearrangements, and some patients pretreated with steroids (\> 48 hours within the week prior to diagnosis) receive prophylactic cranial radiotherapy (CRT) for 8 days, beginning on day 29. Patients then proceed to maintenance therapy. MAINTENANCE THERAPY: All patients receive vincristine IV on days 1, 29, and 57, dexamethasone PO BID on days 1-5, 29-33, and 57-61, MP PO on days 1-84, MTX IT on day 1\*; and MTX PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. NOTE: \*RER (who did not undergo CRT) patients also receive MTX IT on day 29 for maintenance courses 1-4. In all arms, maintenance therapy repeats every 12 weeks until total duration of therapy is 2 years from the start of interim maintenance I for female patients and 3 years from the start of interim maintenance I for male patients. Patients with testicular disease may receive testicular radiotherapy for 8 days during one of the first 3 courses of maintenance therapy. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
Source references
references
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    pmid
    26590194
    type
    DERIVED
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    pmid
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    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        erapy (10-year relapse rate, 22.1% vs. 52.4% with standard-intensity therapy; <em>P</em> = .016).</li></ul></div></li><li>In the COG <a href="/clinicaltrials/NCT00075725">AALL0232 (NCT00075725)</a> study (2004&#8211;2011), patients with high-risk B-ALL received an augmented BFM backbone with one interim maintenance and delayed
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        rate, 22.1% vs. 52.4% with standard-intensity therapy; <em>P</em> = .016).</li></ul></div></li><li>In the COG <a href="/clinicaltrials/NCT00075725">AALL0232 (NCT00075725)</a> study (2004&#8211;2011), patients with high-risk B-ALL received an augmented BFM backbone with one interim maintenance and delayed intensification phase.
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        meaningful differences in cognitive functioning based on corticosteroid randomization.[<a href="#cit/section_8.41">41</a>] In the COG <a href="/clinicaltrials/NCT00075725">AALL0232</a> study, patients with high-risk ALL were randomly assigned to receive either prednisone or dexamethasone during induction therapy.[<a href="#cit/s
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        56</a>,<a href="#cit/section_9.58">58</a>] <div class="pdq-content-list"><ul id="_2118"><li>Use of the pediatric regimen (from the COG <a href="/clinicaltrials/NCT00075725">AALL0232</a> study, which included interim maintenance phases with escalating doses of methotrexate without leucovorin followed by asparaginase) was deemed sa
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        hasone; osteonecrosis was reduced with alternate-week dexamethasone postinduction (57.6% to 5.6%). </li></ul></div></li><li>In the COG <a href="/clinicaltrials/NCT00075725">AALL0232 (NCT00075725)</a> high-risk ALL trial, patients were randomly assigned during induction to receive either 14 days of dexamethasone or 28 days of pred
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        as reduced with alternate-week dexamethasone postinduction (57.6% to 5.6%). </li></ul></div></li><li>In the COG <a href="/clinicaltrials/NCT00075725">AALL0232 (NCT00075725)</a> high-risk ALL trial, patients were randomly assigned during induction to receive either 14 days of dexamethasone or 28 days of prednisone.[<a href="#cit/s
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        Updated: April 21, 2025
        datetime
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        display
        April 21, 2025

    Preserved source evidence · Not medical advice