Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT05559827
Eligibility Criteria:
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)
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 (βHCG 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT05559827
Study Brief:
Protocol Section:
NCT05559827