Open-Label, Phase II Trial of Isatuximab for Patients With Refractory Immune Cytopenias After Allogeneic Hematopoietic Cell Transplantation

Must have received: corticosteroid

Corticosteroid refractoriness: defined as a clear progression or minimal responsiveness of IC(s) after ≥7 days of treatment with prednisone equivalent of ≥1 mg/kg/day.

Must have received: corticosteroid

Corticosteroid dependence: defined as dependence on prednisone equivalent of ≥0.5 mg/kg/day to maintain hemoglobin level ≥2 g/dL nadir level (for AIHA and/or PRCA), and/or platelet count ≥30 x 109/L or ≥2-fold increase from nadir level (for ITP).

Must have received: IVIG

Refractory IC(s) after ≥2 treatment lines including corticosteroids (≥0.5 mg/kg/day prednisone equivalent), IVIG (400 mg/kg/day for 2 to 5 days), and/or rituximab, etc.

Must have received: anti-CD20 antibody (rituximab)

For rituximab treated patients, refractoriness will be defined as no or minimal response within 2 weeks of completing ≥4 doses of rituximab.

Cannot have received: anti-CD38 monoclonal antibody (daratumumab)

hypersensitivity or history of intolerance to ... prior anti-CD38 moAb such as daratumumab

Cannot have received: investigational drug

Received any investigational drug within 14 days or 5 half-lives of the investigational drug prior to initiation of study intervention, whichever is longer.