Clinical trial · Interventional
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Standard Risk B-precursor Acute Lymphoblastic Leukemia (ALL)
NCT00103285CI-TRIAL-00052243completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia. 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Childhood B Acute Lymphoblastic Leukemia | Childhood B Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-Dimensional Conformal Radiation Therapy | Radiation | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Leucovorin Calcium | Drug | Leucovorin | ALIAS |
| Mercaptopurine | Drug | Mercaptopurine | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Group 0 Induction Therapy
- description
- All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
- interventionNames
- Drug: Cytarabine
- Drug: Dexamethasone
- Drug: Leucovorin Calcium
- Drug: Methotrexate
- Drug: Pegaspargase
- Drug: Vincristine Sulfate
- type
- ACTIVE_COMPARATOR
- label
- Group 1-SR-low ALL, Arm I (combination chemotherapy)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 9 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients must be enrolled on AALL03B1 prior to enrollment on AALL0331
* Initial white blood cells (WBC) \< 50,000/ul
* Newly diagnosed B-precursor acute lymphoblastic leukemia
* Standard-risk (SR) disease meeting 1 of the following criteria:
* SR-average by age and WBC
* No unfavorable features
* Rapid early responder (RER) by day 15
* CNS 1 or 2
* Minimal residual disease (MRD) negative on day 29
* Trisomies of 4, 10, and 17 or TEL-AML1 translocation and RER and CNS2 allowed
* SR-low by age and WBC
* No unfavorable features
* RER by day 15
* MRD negative on day 29
* CNS1
* Favorable cytogenetics-trisomies of 4, 10, and 17 or TEL-AML translocation
* SR-high
* Unfavorable features meeting ≥ 1 of the following criteria:
* MLL rearrangements and RER
* Steroid pretreatment
* CNS3
* Slow early responder by morphology or MRD
* Patients with Down syndrome are allowed
* Patients with overt testicular disease are not eligible for this study, but may be eligible for AALL0232
* Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the central nervous system \[CNS\] status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
* Patients receiving prior steroid therapy may be eligible for AALL0331 study
* Patients with a contraindication to additional asparaginase therapy, following Induction, are not eligible for the Standard Risk-Low study, and should be removed from protocol therapy at the end of Induction
* Patients who are assigned to the standard risk-average group following Induction and who meet the HRQOL
* Age at diagnosis \>= 2 years (note that this is a more restrictive age range than for the therapeutic component of the study)
* At least one parent with reading comprehension of English or Spanish languages for which validated surveys exist
* Diagnosis at one of the institutions participating in this limited institution correlative study
* A parent or legal guardian must sign a written informed consent/parental permission for all patients
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metReferences
Publications (7)
- DERIVEDChen 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
- DERIVEDChang 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
- DERIVEDEscherich CS, Chen W, Li Y, Yang W, Nishii R, Li Z, Raetz EA, Devidas M, Wu G, Nichols KE, Inaba H, Pui CH, Jeha S, Camitta BM, Larsen E, Hunger SP, Loh ML, Yang JJ. Germ line genetic NBN variation and predisposition to B-cell acute lymphoblastic leukemia in children. Blood. 2024 May 30;143(22):2270-2283. doi: 10.1182/blood.2023023336. PMID 38446568
- DERIVEDRabin 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
- DERIVEDWood B, Wu D, Crossley B, Dai Y, Williamson D, Gawad C, Borowitz MJ, Devidas M, Maloney KW, Larsen E, Winick N, Raetz E, Carroll WL, Hunger SP, Loh ML, Robins H, Kirsch I. Measurable residual disease detection by high-throughput sequencing improves risk stratification for pediatric B-ALL. Blood. 2018 Mar 22;131(12):1350-1359. doi: 10.1182/blood-2017-09-806521. Epub 2017 Dec 28.