Randomized prospective trial evaluating the efficacy of the antiCD38 monoclonal antibody isatuximab in the treatment of pure cell red aplasia by major ABO mismatch after allogeneic hematopoietic stem cell transplantatio

Phase 1

• Conditions: Pure cell red aplasia by major ABO mismatch after allogeneic hematopoietic stem cell transplantation; MedDRA version: 20.0Level: PTClassification code 10002965Term: Aplasia pure red cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2021-000932-70-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE -HOPITAUX DE PARIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

-Aged 15 years or older
-Having receiving an allogeneic hematopoietic stem cell transplantation in condition of major ABO mismatch
-PCRA defined by persistent red blood cell transfusion dependence at day 60 post-transplant with reticulocytes count under 10 G/L despite full donor chimerism and a good leucocytes (>1 G/L) and platelet (>50G/L) recovery
-No relapse or progression of underlying disease
-Contraception methods must be prescribed during all the duration of the research and using effective contraceptive methods during treatment for women of childbearing age (continue abstinence from heterosexual intercourse is accepted) and for man during the study treatment period and for at least 5 months after the last dose of study treatment and refrain from donating sperm during this period
-With health insurance coverage
-Having signed a written informed consent (2 parents for patients aged less than 18)

Are the trial subjects under 18? yes
Number of subjects for this age range: 6
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Aged < 15 years
-Relapse of underlying disease
-Leucocyte chimerism < 95%
-PRCA related to Parvovirus B19 infection (positive blood PCR)
- Known to be HIV+ or to have hepatitis A, B, or C active infection
- Active tuberculosis
- Pregnancy (ßHCG positive) or breast-feeding.
- Patient receiving recombinant human erythropoietin.
- Patient receiving proteasome inhibitor (Bortezomib for example).
- Patient receiving thrombopoietin receptor agonists (ARTPO).
- Patient receiving plasma or plasmapheresis exchanges after transplant.
- Planned to receive any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
- Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the patient or may interfere with compliance or interpretation of the study results.
- Hypersensitivity to the active substance or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine, hydrochloride, poloxamer 188, sucrose or any of the other components of study therapy that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
- Who have any debilitating medical or psychiatric illness
- Under tutorship or curatorship
- Who not understand informed consent for an optimal treatment and follow-up

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified