Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia

Completed · Not applicable

Conditions studied: L1 Childhood Acute Lymphoblastic Leukemia, L2 Childhood Acute Lymphoblastic Leukemia, Non-T, Non-B Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, T-cell Childhood Acute Lymphoblastic Leukemia

In brief

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining more than one chemotherapy drug with imatinib mesylate may kill more cancer cells. Randomized phase II trial to study the effectiveness of combination chemotherapy and imatinib mesylate in treating children who have relapsed acute lymphoblastic leukemia.

Key facts

Study ID

NCT00049569

Run by

National Cancer Institute (NCI)

People needed

126

Starts

2003-01-01

Last updated by the study team

2013-10-08

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with acute lymphoblastic leukemia (ALL) in first relapse involving the bone marrow (M3 marrow), with or without associated extramedullary disease; this includes patients who are Philadelphia chromosome-positive
• Shortening fraction of >= 28% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study
• Cumulative prior anthracycline exposure of =< 350 mg/m\^2 (each 10 mg/m\^2 dose of idarubicin should be calculated as the isotoxic equivalent of 50 mg/m\^2 of daunorubicin or adriamycin)
• 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

You may not qualify if…

• Patients with B-cell ALL (L3 morphology or evidence of myc translocation by molecular or cytogenetic technique) are not eligible
• Patients with Down syndrome are excluded due to the administration of methotrexate in Block 2
• Patients who have undergone prior stem cell transplantation (SCT) are ineligible if:
• They received SCT less than 12 months prior to study entry
• They are still receiving immunosuppression for the treatment of graft-versus-host disease (GVHD)
• They have active fungal infection at time of study entry
• They have had invasive filamentous fungal infection at any time post-SCT
• Pregnant or lactating females are ineligible as the medications used in this protocol could be harmful to unborn children and infants
• Patients with prior isolated extramedullary relapse are ineligible

Where it is running

• Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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