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
To evaluate the addition of two cycles of blinatumomab for all infants with newly diagnosed ALL and will evaluate in a randomized manner the safety, tolerability, and early activity of venetoclax in infants with KMT2A-R ALL.
• Eligibility Screening: All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to treatment and enrollment on AALL2321.
• Age: Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be > 36 weeks gestational age at the time of enrollment.
• Diagnosis: Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 WHO classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage.
• Patients with Down Syndrome.
• Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy.
• Prior therapy: Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy.
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
ALL, KMT2A-G, KMT2A-R, KMT2A-Rearranged, Newly Diagnosed Acute Lymphoblastic Leukemia