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NCT00430118 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy Based on Risk of Relapse in Treating Young Patients With 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
2013-05-29

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia. PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with 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.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed acute lymphoblastic leukemia (ALL) * No secondary ALL PATIENT CHARACTERISTICS: * No prior disease that would preclude treatment with chemotherapy PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior chemotherapy * More than 4 weeks since prior steroids
healthy Volunteers
false
maximum Age
18 Years
minimum Age
1 Year
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: ifosfamide
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: prednisone
    11. Drug: thioguanine
    12. Drug: vincristine sulfate
    label
    Induction Prot I/Dexa - reinduction Prot III
    type
    EXPERIMENTAL
  2. intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: ifosfamide
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: prednisone
    11. Drug: thioguanine
    12. Drug: vincristine sulfate
    label
    Induction Prot I/Pred - reinduction Prot III
    type
    EXPERIMENTAL
  3. intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: ifosfamide
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: prednisone
    11. Drug: thioguanine
    12. Drug: vincristine sulfate
    label
    Induction Prot I/Dexa - reinduction Prot II
    type
    EXPERIMENTAL
  4. intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: ifosfamide
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: prednisone
    11. Drug: thioguanine
    12. Drug: vincristine sulfate
    label
    Induction Prot I/Pred - reinduction Prot II
    type
    ACTIVE_COMPARATOR
  5. intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: ifosfamide
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: prednisone
    11. Drug: thioguanine
    12. Drug: vincristine sulfate
    label
    Induction Prot I/Dexa - reinduction 2x Prot III
    type
    EXPERIMENTAL
  6. intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: ifosfamide
    8. Drug: mercaptopurine
    9. Drug: methotrexate
    10. Drug: prednisone
    11. Drug: thioguanine
    12. Drug: vincristine sulfate
    label
    Induction Prot I/Pred - reinduction 2x Prot III
    type
    EXPERIMENTAL
  7. intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: etoposide
    8. Drug: ifosfamide
    9. Drug: mercaptopurine
    10. Drug: methotrexate
    11. Drug: prednisone
    12. Drug: thioguanine
    label
    Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
    type
    EXPERIMENTAL
  8. intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: etoposide
    8. Drug: ifosfamide
    9. Drug: mercaptopurine
    10. Drug: methotrexate
    11. Drug: prednisone
    12. Drug: thioguanine
    label
    Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
    type
    EXPERIMENTAL
  9. intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: etoposide
    8. Drug: ifosfamide
    9. Drug: mercaptopurine
    10. Drug: methotrexate
    11. Drug: prednisone
    12. Drug: thioguanine
    label
    Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
    type
    EXPERIMENTAL
  10. intervention Names
    1. Drug: asparaginase
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: dexamethasone
    6. Drug: doxorubicin hydrochloride
    7. Drug: etoposide
    8. Drug: ifosfamide
    9. Drug: mercaptopurine
    10. Drug: methotrexate
    11. Drug: prednisone
    12. Drug: thioguanine
    label
    Induction Prot I/Pred - reinduction 6 HR courses + Prot II
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Induction Prot I/Dexa - reinduction 2x Prot III
    2. Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
    3. Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
    4. Induction Prot I/Dexa - reinduction Prot II
    5. Induction Prot I/Dexa - reinduction Prot III
    6. Induction Prot I/Pred - reinduction 2x Prot III
    7. Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
    8. Induction Prot I/Pred - reinduction 6 HR courses + Prot II
    9. Induction Prot I/Pred - reinduction Prot II
    10. Induction Prot I/Pred - reinduction Prot III
    name
    asparaginase
    type
    DRUG
  2. arm Group Labels
    1. Induction Prot I/Dexa - reinduction 2x Prot III
    2. Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
    3. Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
    4. Induction Prot I/Dexa - reinduction Prot II
    5. Induction Prot I/Dexa - reinduction Prot III
    6. Induction Prot I/Pred - reinduction 2x Prot III
    7. Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
    8. Induction Prot I/Pred - reinduction 6 HR courses + Prot II
    9. Induction Prot I/Pred - reinduction Prot II
    10. Induction Prot I/Pred - reinduction Prot III
    name
    cyclophosphamide
    type
    DRUG
  3. arm Group Labels
    1. Induction Prot I/Dexa - reinduction 2x Prot III
    2. Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
    3. Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
    4. Induction Prot I/Dexa - reinduction Prot II
    5. Induction Prot I/Dexa - reinduction Prot III
    6. Induction Prot I/Pred - reinduction 2x Prot III
    7. Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
    8. Induction Prot I/Pred - reinduction 6 HR courses + Prot II
    9. Induction Prot I/Pred - reinduction Prot II
    10. Induction Prot I/Pred - reinduction Prot III
    name
    cytarabine
    type
    DRUG
  4. arm Group Labels
    1. Induction Prot I/Dexa - reinduction 2x Prot III
    2. Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
    3. Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
    4. Induction Prot I/Dexa - reinduction Prot II
    5. Induction Prot I/Dexa - reinduction Prot III
    6. Induction Prot I/Pred - reinduction 2x Prot III
    7. Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
    8. Induction Prot I/Pred - reinduction 6 HR courses + Prot II
    9. Induction Prot I/Pred - reinduction Prot II
    10. Induction Prot I/Pred - reinduction Prot III
    name
    daunorubicin hydrochloride
    type
    DRUG
  5. arm Group Labels
    1. Induction Prot I/Dexa - reinduction 2x Prot III
    2. Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
    3. Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
    4. Induction Prot I/Dexa - reinduction Prot II
    5. Induction Prot I/Dexa - reinduction Prot III
    6. Induction Prot I/Pred - reinduction 2x Prot III
    7. Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
    8. Induction Prot I/Pred - reinduction 6 HR courses + Prot II
    9. Induction Prot I/Pred - reinduction Prot II
    10. Induction Prot I/Pred - reinduction Prot III
    name
    dexamethasone
    type
    DRUG
  6. arm Group Labels
    1. Induction Prot I/Dexa - reinduction 2x Prot III
    2. Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
    3. Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
    4. Induction Prot I/Dexa - reinduction Prot II
    5. Induction Prot I/Dexa - reinduction Prot III
    6. Induction Prot I/Pred - reinduction 2x Prot III
    7. Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
    8. Induction Prot I/Pred - reinduction 6 HR courses + Prot II
    9. Induction Prot I/Pred - reinduction Prot II
    10. Induction Prot I/Pred - reinduction Prot III
    name
    doxorubicin hydrochloride
    type
    DRUG
  7. arm Group Labels
    1. Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
    2. Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
    3. Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
    4. Induction Prot I/Pred - reinduction 6 HR courses + Prot II
    name
    etoposide
    type
    DRUG
  8. arm Group Labels
    1. Induction Prot I/Dexa - reinduction 2x Prot III
    2. Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
    3. Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
    4. Induction Prot I/Dexa - reinduction Prot II
    5. Induction Prot I/Dexa - reinduction Prot III
    6. Induction Prot I/Pred - reinduction 2x Prot III
    7. Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
    8. Induction Prot I/Pred - reinduction 6 HR courses + Prot II
    9. Induction Prot I/Pred - reinduction Prot II
    10. Induction Prot I/Pred - reinduction Prot III
    name
    ifosfamide
    type
    DRUG
  9. arm Group Labels
    1. Induction Prot I/Dexa - reinduction 2x Prot III
    2. Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
    3. Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
    4. Induction Prot I/Dexa - reinduction Prot II
    5. Induction Prot I/Dexa - reinduction Prot III
    6. Induction Prot I/Pred - reinduction 2x Prot III
    7. Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
    8. Induction Prot I/Pred - reinduction 6 HR courses + Prot II
    9. Induction Prot I/Pred - reinduction Prot II
    10. Induction Prot I/Pred - reinduction Prot III
    name
    mercaptopurine
    type
    DRUG
  10. arm Group Labels
    1. Induction Prot I/Dexa - reinduction 2x Prot III
    2. Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
    3. Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
    4. Induction Prot I/Dexa - reinduction Prot II
    5. Induction Prot I/Dexa - reinduction Prot III
    6. Induction Prot I/Pred - reinduction 2x Prot III
    7. Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
    8. Induction Prot I/Pred - reinduction 6 HR courses + Prot II
    9. Induction Prot I/Pred - reinduction Prot II
    10. Induction Prot I/Pred - reinduction Prot III
    name
    methotrexate
    type
    DRUG
  11. arm Group Labels
    1. Induction Prot I/Dexa - reinduction 2x Prot III
    2. Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
    3. Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
    4. Induction Prot I/Dexa - reinduction Prot II
    5. Induction Prot I/Dexa - reinduction Prot III
    6. Induction Prot I/Pred - reinduction 2x Prot III
    7. Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
    8. Induction Prot I/Pred - reinduction 6 HR courses + Prot II
    9. Induction Prot I/Pred - reinduction Prot II
    10. Induction Prot I/Pred - reinduction Prot III
    name
    prednisone
    type
    DRUG
  12. arm Group Labels
    1. Induction Prot I/Dexa - reinduction 2x Prot III
    2. Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot III
    3. Induction Prot I/Dexa - reinduction 6 HR courses + Prot II
    4. Induction Prot I/Dexa - reinduction Prot II
    5. Induction Prot I/Dexa - reinduction Prot III
    6. Induction Prot I/Pred - reinduction 2x Prot III
    7. Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot III
    8. Induction Prot I/Pred - reinduction 6 HR courses + Prot II
    9. Induction Prot I/Pred - reinduction Prot II
    10. Induction Prot I/Pred - reinduction Prot III
    name
    thioguanine
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
FACTORIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
4559
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Efficacy of dexamethasone vs prednisone during the induction phase
    time Frame
    End of Trial
  2. measure
    Event-free survival (EFS) and overall survival after initial remission in intermediate-risk and high-risk patients
    time Frame
    End of Trial
  3. measure
    Safety and efficacy of treatment reduction during reintensification in standard-risk patients
    time Frame
    End of Trial
  4. measure
    EFS after second delayed reintensification in intermediate-risk patients
    time Frame
    End of Trial
  5. measure
    Outcome after extended reintensification therapy in high-risk patients
    time Frame
    End of Trial
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia. PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.
detailed Description
OBJECTIVES: * Compare the relative efficacy of induction therapy comprising dexamethasone or prednisone, in terms of a higher rate of event-free survival (EFS) and overall survival and a reduced rate of relapse, in pediatric patients with intermediate-risk or high-risk acute lymphoblastic leukemia (ALL). * Compare the relative safety of a reduced-intensity reintensification regimen comprising dexamethasone, vincristine, cyclophosphamide, and anthracyclines vs a standard treatment regimen in pediatric patients with standard-risk ALL identified by fast clearance of leukemic cells. * Compare the efficacy of a second delayed reintensification regimen vs standard reintensification therapy, in terms of improved EFS, in pediatric patients with intermediate-risk ALL. * Compare the efficacy of extended reintensification therapy (triple reinduction) vs standard reintensification therapy (intensive pulses and one reintensification) in pediatric patients with high-risk ALL. OUTLINE: This is a randomized, multicenter study. * Prednisone prephase therapy: Patients receive oral prednisone on days 1-7 and one dose of methotrexate (MTX) intrathecally (IT) on day 1. * Induction/consolidation therapy, protocol I: Patients are randomized to 1 of 2 treatment arms. * Arm I (closed to accrual as of 6/30/2006): Patients receive prednisone (PRED) on days 8-28. * Arm II (closed to accrual as of 6/30/2006): Patients receive dexamethasone (DEXA) on days 8-28. Patients in both arms also receive vincristine (VCR) and daunorubicin hydrochloride (DNR) once weekly in weeks 2-5; asparaginase (ASP) on days 12-33; cyclophosphamide (CPM) on days 36 and 64; cytarabine (ARA-C) in weeks 6-9; mercaptopurine (MP) on days 36-63; and MTX IT on days 1, 12, 33, 45, and 59.\* NOTE: \*Patients with CNS disease also receive MTX IT on days 18 and 27. After completion of induction/consolidation therapy, patients are stratified according to risk group based on disease response (standard-risk \[SR\] group \[negative minimal residual disease (MRD) on day 33 and before protocol M, day 78\] vs high-risk \[HR\] group \[MRD ≥ 10\^-³ on day 78\] vs intermediate-risk \[IR\] group \[all nonSR/nonHR\]).\* Patients with SR and IR disease proceed to extracompartment therapy. Patients with HR disease proceed to reintensification therapy. NOTE: \*Patients meeting any of the following criteria are placed in the HR group regardless of MRD response: Philadelphia chromosome-positive disease (BCR/ABL or t\[9;22\]; translocations \[t4;11\]\[q11;q23\] or MLL/AF4); "prednisone-poor-response" (≥ 1,000 blasts/mm³ in the peripheral blood on day 8 after prednisone prephase therapy); or no response to study induction therapy (M2/3 at day 33). * Extracompartment therapy, protocol M: Patients receive MP on days 1-56 and MTX on days 8, 22, 36, and 50. After completion of extracompartment therapy, SR and IR patients proceed to reintensification therapy. SR patients are randomized to arms I or II. IR patients are randomized to arms I or III. HR patients who have completed induction/consolidation therapy are randomized to arms IV or V. * Reintensification therapy: * Arm I (standard reinduction therapy, protocol II \[closed to accrual as of 6/30/2006\]): SR and IR patients receive DEXA on days 1-22; VCR and doxorubicin hydrochloride (DOX) in weeks 2-5; ASP on days 8, 11, 15, and 18; CPM on day 36; ARA-C and thioguanine (TG) on days 36-49; and MTX IT on days 38 and 45.\* Patients then proceed to maintenance therapy. NOTE: \*Patients with CNS disease also receive MTX IT on days 1 and 18. * Arm II (reduced-intensity reinduction therapy, protocol III \[closed to accrual as of 6/30/2006\]): SR patients receive DEXA on days 1-15; VCR and DOX on days 1 and 8; ASP on days 1, 4, 8, and 11; CPM on day 15; ARA-C and TG on days 15-28; and MTX IT on days 17 and 24.\* Patients then proceed to maintenance therapy. NOTE: \*Patients with CNS disease also receive MTX on day 1. * Arm III (reduced-intensity reinduction/second delayed reinduction therapy \[double reintensification therapy\] \[closed to accrual as of 6/30/2006\]): IR patients receive reduced-intensity reintensification therapy as in arm II. After a 10-week interim maintenance phase, treatment repeats once for a second delayed course of reintensification therapy. Patients then proceed to maintenance therapy. * Arm IV (standard reintensification therapy \[closed to accrual as of 6/30/2006\]): HR patients receive two sequences of the following HR therapy elements (i.e., in this order: 1, 2, 3, 1, 2, 3) following reintensification therapy as in arm I. Patients then proceed to maintenance therapy. * Element HR-1: Patients receive DEXA on days 1-5; VCR on days 1 and 6; ARA-C twice on day 5; MTX and CPM every 12 hours on days 2-4 (5 doses); ASP on days 6 and 11; and MTX/ARA-C/PRED IT on day 1. * Element HR-2: Patients receive DEXA on days 1-5; vindesine on days 1 and 6; DNR on day 5; MTX and ifosfamide every 12 hours on days 2-4 (5 doses); ASP on days 6 and 11; and MTX/ARA-C/PRED IT on day 1.\* NOTE: \*HR patients with CNS disease also receive IT therapy on day 5. * Element HR-3: Patients receive DEXA on days 1-5; ARA-C every 12 hours on days 1-2 (4 doses); etoposide five times daily on days 3-5; ASP on days 6 and 11; and MTX/ARA-C/PRED IT on day 1. * Arm V (extended reintensification therapy \[triple protocol III\] \[closed to accrual as of 6/30/2006\]): HR patients receive HR therapy elements 3, 2, and 1 as in arm IV following reintensification therapy as in arm II repeated the therapy element twice with 4-week interim maintenance phases in between. Patients then proceed to maintenance therapy. * Interim maintenance/maintenance therapy: Patients receive MTX once weekly and MP daily until week 104. * Radiotherapy: HR patients or patients with T-cell acute lymphoblastic leukemia or CNS disease undergo CNS radiotherapy. PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
Source references
references
  1. citation
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    18565891
    type
    BACKGROUND
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    pmid
    21719599
    type
    RESULT
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    pmid
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    type
    RESULT
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    pmid
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    pmid
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    type
    RESULT
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    pmid
    18780832
    type
    RESULT
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    pmid
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    type
    RESULT
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    pmid
    36639636
    type
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    Stanulla M, Dagdan E, Zaliova M, Moricke A, Palmi C, Cazzaniga G, Eckert C, Te Kronnie G, Bourquin JP, Bornhauser B, Koehler R, Bartram CR, Ludwig WD, Bleckmann K, Groeneveld-Krentz S, Schewe D, Junk SV, Hinze L, Klein N, Kratz CP, Biondi A, Borkhardt A, Kulozik A, Muckenthaler MU, Basso G, Valsecchi MG, Izraeli S, Petersen BS, Franke A, Dorge P, Steinemann D, Haas OA, Panzer-Grumayer R, Cave H, Houlston RS, Cario G, Schrappe M, Zimmermann M; TRANSCALL Consortium; International BFM Study Group. IKZF1plus Defines a New Minimal Residual Disease-Dependent Very-Poor Prognostic Profile in Pediatric B-Cell Precursor Acute Lymphoblastic Leukemia. J Clin Oncol. 2018 Apr 20;36(12):1240-1249. doi: 10.1200/JCO.2017.74.3617. Epub 2018 Mar 2.
    pmid
    29498923
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    Schrappe M, Bleckmann K, Zimmermann M, Biondi A, Moricke A, Locatelli F, Cario G, Rizzari C, Attarbaschi A, Valsecchi MG, Bartram CR, Barisone E, Niggli F, Niemeyer C, Testi AM, Mann G, Ziino O, Schafer B, Panzer-Grumayer R, Beier R, Parasole R, Gohring G, Ludwig WD, Casale F, Schlegel PG, Basso G, Conter V. Reduced-Intensity Delayed Intensification in Standard-Risk Pediatric Acute Lymphoblastic Leukemia Defined by Undetectable Minimal Residual Disease: Results of an International Randomized Trial (AIEOP-BFM ALL 2000). J Clin Oncol. 2018 Jan 20;36(3):244-253. doi: 10.1200/JCO.2017.74.4946. Epub 2017 Nov 17.
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    26913693
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    Moricke A, Zimmermann M, Valsecchi MG, Stanulla M, Biondi A, Mann G, Locatelli F, Cazzaniga G, Niggli F, Arico M, Bartram CR, Attarbaschi A, Silvestri D, Beier R, Basso G, Ratei R, Kulozik AE, Lo Nigro L, Kremens B, Greiner J, Parasole R, Harbott J, Caruso R, von Stackelberg A, Barisone E, Rossig C, Conter V, Schrappe M. Dexamethasone vs prednisone in induction treatment of pediatric ALL: results of the randomized trial AIEOP-BFM ALL 2000. Blood. 2016 Apr 28;127(17):2101-12. doi: 10.1182/blood-2015-09-670729. Epub 2016 Feb 17.
    pmid
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    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        significant in T-ALL.[<a href="#cit/section_4.141">141</a>] In the Associazione Italiana di Ematologia e Oncologia Pediatrica (AIEOP) <a href="/clinicaltrials/NCT00430118">ALL-BFM-2000 (NCT00430118)</a> trial, MRD status at day 78 (week 12) was the most important predictor for relapse in patients with T-ALL.[<a href="#cit/sectio
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        ref="#cit/section_4.141">141</a>] In the Associazione Italiana di Ematologia e Oncologia Pediatrica (AIEOP) <a href="/clinicaltrials/NCT00430118">ALL-BFM-2000 (NCT00430118)</a> trial, MRD status at day 78 (week 12) was the most important predictor for relapse in patients with T-ALL.[<a href="#cit/section_4.141">141</a>] Patients
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        th rates between the randomized groups.</li></ul></div></li><li>The Associazione Italiana di Ematologia e Oncologia Pediatrica (AIEOP) <a href="/clinicaltrials/NCT00430118">ALL-BFM-2000 (NCT00430118)</a> trial randomly assigned 3,720 patients to receive either dexamethasone (10 mg/m<span class="sup">2</span>/d) or prednisone (60
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        ized groups.</li></ul></div></li><li>The Associazione Italiana di Ematologia e Oncologia Pediatrica (AIEOP) <a href="/clinicaltrials/NCT00430118">ALL-BFM-2000 (NCT00430118)</a> trial randomly assigned 3,720 patients to receive either dexamethasone (10 mg/m<span class="sup">2</span>/d) or prednisone (60 mg/m<span class="sup">2</sp
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        ly assigned to that arm, and one patient experienced a treatment-related death during that phase.</li></ul></div></li><li>In the AIEOP <a href="/clinicaltrials/NCT00430118">ALL-BFM-2000 (NCT00430118)</a> trial, standard-risk patients (defined as those with undetectable MRD at days 33 and 78 and absence of high-risk cytogenetics)
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        d one patient experienced a treatment-related death during that phase.</li></ul></div></li><li>In the AIEOP <a href="/clinicaltrials/NCT00430118">ALL-BFM-2000 (NCT00430118)</a> trial, standard-risk patients (defined as those with undetectable MRD at days 33 and 78 and absence of high-risk cytogenetics) were randomly assigned to r
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        sis, without any advantage in outcome with the utilization of HSCT compared with chemotherapy alone.</li></ul></div></li><li>The AIEOP <a href="/clinicaltrials/NCT00430118">ALL-BFM-2000 (NCT00430118)</a> study (2000&#8211;2006) classified patients as high risk if they met any of the following criteria: poor response to prednisone
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        in outcome with the utilization of HSCT compared with chemotherapy alone.</li></ul></div></li><li>The AIEOP <a href="/clinicaltrials/NCT00430118">ALL-BFM-2000 (NCT00430118)</a> study (2000&#8211;2006) classified patients as high risk if they met any of the following criteria: poor response to prednisone prophase, failure to achie
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        Updated: April 21, 2025
        datetime
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        April 21, 2025

    Preserved source evidence · Not medical advice