International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
Overview
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.
Description
The purpose of this study is to compare disease-free survival (DFS) of standard risk pediatric Philapdelphia chromosome (Ph)+ acute lymphoblastic leukemia (ALL) treated with continuous imatinib mesylate (imatinib) combined with either a high-risk Children's Oncology Group (COG)/Berlin-Frankfurt-Munster (BFM) ALL chemotherapy backbone or the more intensive European (Es)PhALL chemotherapy backbone.
Eligibility
You may be eligible for this study if you meet the following criteria:
- Conditions: Lymphoblastic Leukemia
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Age: Between 2 Years - 21 Years
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Gender: Male or Female
Inclusion Criteria
Patients who have not previously enrolled on AALL08B1 or APEC14B1 (if open for classification of newly diagnosed ALL patients) prior to enrollment on AALL1631, a baseline diagnostic sample must be available to develop an MRD probe
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
For patients who DO NOT enter AALL1631 via AALL08B1 or APEC14B1 (if open for classification of newly diagnosed ALL patients), laboratory reports detailing evidence of BCR-ABL1 fusion must be submitted for rapid central review within 72 hours of study enrollment
Patients with known chronic myelogenous leukemia (CML) who develop lymphoid blast crisis are not eligible
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 induction therapy
Patient has not had prior treatment with imatinib, dasatinib, or any other BCR-ABL1 inhibitor
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
Additional Information:Patients who have not previously enrolled on AALL08B1 or APEC14B1 (if open for classification of newly diagnosed ALL patients) prior to enrollment on AALL1631, a baseline diagnostic sample must be available to develop an MRD probe
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
For patients who DO NOT enter AALL1631 via AALL08B1 or APEC14B1 (if open for classification of newly diagnosed ALL patients), laboratory reports detailing evidence of BCR-ABL1 fusion must be submitted for rapid central review within 72 hours of study enrollment
Patients with known chronic myelogenous leukemia (CML) who develop lymphoid blast crisis are not eligible
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 induction therapy
Patient has not had prior treatment with imatinib, dasatinib, or any other BCR-ABL1 inhibitor
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
Participants will not be paid for their participation.
Updated on
20 Nov 2022
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Study ID: TX8239
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