AALL2321; A Phase 2 Study of Blinatumomab in Combination with Chemotherapy for Infants with Newly Diagnosed Acute Lymphoblastic Leukemia with Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax
The purpose of this study is to learn whether adding venetoclax and/or blinatumomab to standard chemotherapy is safe and may improve treatment for infants with newly diagnosed acute lymphoblastic leukemia (ALL). We want to learn how well these treatments work and what side effects they may cause. What we learn may help improve future treatment options for infants with ALL
• age 1 year or younger at diagnosis
• diagnosed with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL) or a related acute leukemia with B-cell features
• more than 36 weeks gestational age at the time of enrollment
• see link to clinicaltrials.gov for complete inclusion criteria
• have Down syndrome
• developed B-ALL after treatment for a previous cancer
• have previously received chemotherapy for this leukemia or another cancer, except for certain limited treatments allowed by the study
• see link to clinicaltrials.gov for complete exclusion criteria
Drug: Asparaginase Erwinia chrysanthemi, Procedure: Biospecimen Collection, Biological: Blinatumomab, Procedure: Bone Marrow Aspiration, Drug: Calaspargase Pegol, Procedure: Computed Tomography, Drug: Cyclophosphamide, Drug: Cytarabine, Drug: Daunorubicin, Drug: Dexamethasone, Drug: Doxorubicin, Procedure: Echocardiography Test, Procedure: FDG-Positron Emission Tomography, Drug: Leucovorin, Drug: Levoleucovorin, Procedure: Lumbar Puncture, Procedure: Magnetic Resonance Imaging, Drug: Mercaptopurine, Drug: Methotrexate, Drug: Methylprednisolone, Procedure: Multigated Acquisition Scan, Drug: Prednisolone, Drug: Prednisone, Drug: Therapeutic Hydrocortisone, Drug: Thioguanine, Drug: Venetoclax, Drug: Vincristine
Blood Disorders, Cancer, Children's Health
Acute Lymphoblastic Leukemia, acute lymphoblastic leukemia, ALL, KMT2A-G, KMT2A-R, KMT2A-Rearranged