ALaCART-B: Acute Leukemia and Chimeric Antigen Receptor-T Cell Therapy for B-lymphoblastic Leukemia.
Trial Parameters
Brief Summary
The objective of this study is to assess the safety and efficacy of a immunophenotype-adapted approach using CAR T-cells in patients with high-risk, refractory or relapsed B-lineage acute lymphoblastic leukemia (B-ALL).
Eligibility Criteria
Inclusion Criteria: * Fulfil the Diagnosis/ Disease define as: 1. Relapsed B-cell acute lymphoblastic leukaemia/ lymphoma as defined by: Bone marrow disease = or \> 0.01% by MRD as determined by flow cytometry Or CNS disease as defined as \> 5 WBCs in CSF by morphology, or flow cytometric or molecular evidence of blasts or biopsy proven recurrence in the eye or brain. Or Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites 2. Induction failure as defined by Day 33/ End of induction: MRD ≥ 1% by flow cytometry on the Ma-Spore ALL 2020 protocol Or Failure to achieve morphological remission defined as \> 5% blasts after standard induction chemotherapy 3. Refractory disease as defined by: MRD ≥ 0.01% by flow cytometry or molecular methods during 2 or more timepoints after induction therapy 4. Any high risk features including : BCR-ABL1, BCR-ABL1-like, - ABL1-r, PDGFRB-r, TCF3-HLF, MLL-r, hypodiploid ALL (\< 45 chromosomes), p