International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
Study on Investigational Approaches for Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Brief description of study.
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) ,Chromosome-Positive Acute Lymphoblastic Leukemia,Ph+ALL,Lymphoblastic Leukemia,Lymphoblastic,Leukemia,Cancer,Oncology,Pediatric,Kid,Kids,Teen,Teens,Teenager,Teenagers,Child,Children,Adolescent,Youth
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Age: 2 years - 21 years
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Gender: All
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
This study investigates treatments for Philadelphia chromosome positive acute lymphoblastic leukemia (ALL), a type of cancer affecting the blood and bone marrow. The purpose of this study is to examine the effectiveness of combining an investigational medication with different chemotherapy approaches to improve disease-free survival in children with standard risk ALL. The investigational medication is used alongside either a high-risk Children's Oncology Group (COG)/Berlin-Frankfurt-Munster (BFM) ALL chemotherapy backbone or a more intensive European (Es)PhALL chemotherapy backbone.
Participants will undergo specific procedures, including receiving the investigational medication and chemotherapy as part of their treatment plan. Chemotherapy involves using drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. The study will help determine which combination is more effective for patients.
- Who can participate: Children newly diagnosed with Philadelphia chromosome positive acute lymphoblastic leukemia can participate. They must have definitive evidence of BCR-ABL1 fusion by karyotype, FISH, or RT-PCR, not have started treatment with certain medications, and meet specific health criteria. Those with Down syndrome, a history of chronic myelogenous leukemia, or certain heart conditions are excluded.
- Study details: Participants will receive an investigational medication alongside chemotherapy. Some will receive the medication with a standard chemotherapy regimen, while others will receive it with a more intensive regimen.
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