Pure cell red aplasia by major ABO mismatch after allogeneic hematopoietic stem cell transplantation
Conditions
Brief summary
Time to obtention of transfusion independence for patients with PRCA: time interval between randomization (corresponding to the M6 post-transplant) and resolution of PRCA (date of resolution of reticulocytopenia) treated or not by the anti-CD 38 monoclonal antibody isatuximab
Detailed description
-Number of red blood cell transfusions after randomization -Ferritin levels at M6, M9 and M15 post-transplant -Adverse events (CTC-AE grade ≥ 2) after randomization -Quality of life questionnaire (EORTC QLQ-C30- v3) at D60, D100, M6, M9, M12, M15 post-transplant, Factors associated with spontaneous resolution of PRCA between D60 and M6 post-transplant, - Antibody level (anti A and/or anti B titers) at D60, D100, M6 post-transplant then at each visit d15, d29, d45, and M3, M6, M9 post randomization,, - Number of days of hospitalization, transfusions support and chelation treatments
Interventions
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to obtention of transfusion independence for patients with PRCA: time interval between randomization (corresponding to the M6 post-transplant) and resolution of PRCA (date of resolution of reticulocytopenia) treated or not by the anti-CD 38 monoclonal antibody isatuximab | — |
Secondary
| Measure | Time frame |
|---|---|
| -Number of red blood cell transfusions after randomization -Ferritin levels at M6, M9 and M15 post-transplant -Adverse events (CTC-AE grade ≥ 2) after randomization -Quality of life questionnaire (EORTC QLQ-C30- v3) at D60, D100, M6, M9, M12, M15 post-transplant, Factors associated with spontaneous resolution of PRCA between D60 and M6 post-transplant, - Antibody level (anti A and/or anti B titers) at D60, D100, M6 post-transplant then at each visit d15, d29, d45, and M3, M6, M9 post randomization,, - Number of days of hospitalization, transfusions support and chelation treatments | — |
Countries
France
Outcome results
None listed