A Study Testing the Combo of Dasatinib or Imatinib to Chemo Treatment W/ Blinatumomab for Children, Adolescents, & YA W/ Ph+ or Ph-Like B-cell B-ALL
A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
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Clinical Trial Information
Trial Contact: Frankos, Marie; Jones, Jamie; Singh, Sarah H; Parker, Melanie; Armatti, Julie M; Torrescano, Tanner
Trial Phone: 321-842-8738 ; 3218412008 ; 321.841.7561 ; 321-843-1036 ; 321-843-5284 ; 321-841-8271
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IRB No: AALL2131
Protocol Abbrev: AALL2131
Principal Investigator: Jaime H Mercado, MD
Phase: Drug: Phase III
Age Group: Adult; Pediatric
Treatment: Procedure: Biospecimen Collection Biological: Blinatumomab Procedure: Bone Marrow Biopsy Drug: Calaspargase Pegol Drug: Cyclophosphamide Drug: Cytarabine Drug: Dasatinib Drug: Daunorubicin Drug: Doxorubicin Procedure: Echocardiography Test Drug: Imatinib Drug: Leucovorin Drug: Mercaptopurine Drug: Methotrexate Procedure: Multigated Acquisition Scan Drug: Pegaspargase Drug: Prednisolone Drug: Prednisone Drug: Thioguanine Radiation: Radiation Therapy Drug: Vincristine
ClinicalTrials.gov ID: NCT06124157
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Objective
PRIMARY OBJECTIVES:
I. To estimate the 3-year event free survival (EFS) of children, adolescents, and young adults <25 years old with newly-diagnosed Ph+ (BCR::ABL1-rearranged) B- ALL who are treated with a modified Berlin-Frankfurt-Münster (mBFM) chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous dasatinib.
II. To estimate the 3-year EFS of children, adolescents, and young adults <25 years old with newly-diagnosed ABL-class Ph-like B-ALL who are treated with a modified BFM chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous imatinib for those with PDGFRB gene fusions or dasatinib for those without PDGFRB gene fusions.
III. To describe the safety and toxicity profile (infections, mucositis, neurotoxicity, cytokine release syndrome, hypogammaglobulinemia, therapy delays > 14 days, and treatment-related mortality) for patients with Ph+ or ABL-class Ph-like B-ALL treated on this novel chemo-immunotherapy backbone with continuous tyrosine kinase inhibitor (TKI).
