Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Completed · Phase 3

Conditions studied: Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT00103285

Run by

Children's Oncology Group

People needed

5377

Starts

2005-04-11

Expected to finish

2021-03-31

Last updated by the study team

2021-06-14

Who can join

Age: 1 and older, up to 9. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• USA Health Strada Patient Care Center — Mobile, Alabama, United States
• Banner Children's at Desert — Mesa, Arizona, United States
• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente Downey Medical Center — Downey, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Mattel Children's Hospital UCLA — Los Angeles, California, United States
• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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