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Randomized prospective trial evaluating the efficacy of the antiCD38 monoclonal antibody isatuximab in the treatment of PCRA by major ABO mismatch after allogeneic hematopoietic stem cell transplantation
EU CTIS ID: 2024-514351-14-00
What this study is testing
Efficacy of the treatment of PRCA by isatuximab after allogeneic hematopoietic stem cell transplant compared to supportive care only control group (reduction in PRCA resolution time in days)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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 clinical trial 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
You likely can't join if
- - Aged < 15 years
- 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.
See the full eligibility 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 clinical trial 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)
- - Aged < 15 years
- 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
- - 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 (βHCG positive) or breast-feeding.
- Patient receiving recombinant human erythropoietin.
- Patient receiving proteasome inhibitor (Bortezomib for example).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.