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Imatinib Mesylate and Combination Chemotherapy in Treating Patients with Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
Not Available
Phase III
Both
Not Available
Not Available
Zarnegar-Lumley, Sara
International
Vanderbilt University
06-04-2019
Treatment
COGAALL1631
NCT03007147

Eligibility

2 Years
BOTH
NO
Inclusion Criteria:

For patients enrolled on AALL08B1 or APEC14B1 (if open for ALL patients) prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled * For patients who have not previously enrolled on AALL08B1 or APEC14B1 (if open for ALL patients) prior to enrollment on AALL1631, a baseline diagnostic sample must be available to develop an MRD probe * In addition, laboratory reports detailing evidence of BCR-ABL1 fusion must be submitted for rapid central review within 72 hours of study enrollment

Newly diagnosed de novo ALL (B-ALL or T-ALL) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR

Patient must have previously started induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy

Patient has not received more than 14 days of multiagent induction therapy beginning with the first dose of vinCRIStine

Patient may have started imatinib prior to study entry but has not received more than 14 days of imatinib

Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2

Direct bilirubin =
Shortening fraction of >= 27% by echocardiogram

Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram

Corrected QT interval, QTc
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2

Serum creatinine within normal limits based on age/gender, as follows: * 1 to = 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)



Exclusion Criteria:

Known history of chronic myelogenous leukemia (CML)

ALL developing after a previous cancer treated with cytotoxic chemotherapy

Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation

Down syndrome

Pregnancy and breast feeding * Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential * Lactating females who plan to breastfeed their infants * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block

Prior treatment with dasatinib, or any BCR-ABL1 inhibitor other than imatinib

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

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