Efficacy of the antiCD38 Monoclonal Antibody Isatuximab in the Treatment of PCRA by Major ABO Mismatch After Allogeneic Hematopoietic Stem Cell Transplantation

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

September 30, 2022

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Immunological Pure Red Cell Aplasia
Interventions
DRUG

Isatuximab

Isatuximab treatment at a dose of 10 mg/kg by intravenous route. The first injection of isatuximab will be performed at randomization (month 6 +/- 2 days). A second injection may be performed at day 15 if the reticulocytes \<10 G / L, and a third at day 29 if reticulocytes \<10 G / L. Patients will be assessed on day 1, day 15, day 29, day 45, 2 months, 3 months, 6 months and 9 months after randomization.

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER