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:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-24 @ 9:41 PM
NCT ID:
NCT05284032
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, age ≥ 18 years
4. Diagnosis of immune mediated platelet transfusion refractoriness secondary to class I anti-HLA antibodies according to institutional practice, including calculated percent panel-reactive antibodies (%PRA) \> 80%
5. Adequate Organ Function:
* serum creatinine \<= 1.5 x upper limit of normal
* bilirubin \<= 1.5 x upper limit of normal (exceptions for Gilbert's disease)
* AST and ALT \<= 2.5 x upper limit of normal
* Alkaline phosphatase \<= 2.5 x upper limit of normal
6. For females and males of reproductive potential: agreement to use adequate contraception (see section 5.3)
7. Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration
Exclusion Criteria:
1. Immune-mediated platelet refractoriness other than anti-HLA antibody-mediated
2. Non-immune-mediated platelet refractoriness (e.g. splenomegaly or disseminated intravascular coagulation)
3. Diagnosis of thrombocytopenia induced by other drugs, such as vancomycin, heparin, or amphotericin
4. Diagnosis of thrombotic thrombocytopenic purpura or idiopathic immune thrombocytopenia
5. Active bleeding
6. Greater than Grade 2 active graft versus host disease (GVHD) following allogeneic HSCT
7. Bi-directional ABO mismatched allogeneic stem cell transplantation
8. Prior administration of daratumumab, isatuximab or any other anti-CD38 antibodies
9. Known uncontrolled HIV disease and/or active Hepatitis A, B, or C infection
10. Active systemic infection and severe infections requiring treatment with a parenteral administration of antimicrobials.
* Controlled systemic infections on antimicrobial therapy that are stable at the time of screening are not an exclusion criterion.
11. Hypersensitivity 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 intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
12. Received any investigational drug within 14 days or 5 half-lives of the investigational drug prior to initiation of study intervention, whichever is longer. In case of very aggressive disease (i.e acute leukemia) delay could be shortened after agreement between sponsor and investigator, in absence of residual toxicities from previous therapy
13. Pregnancy or lactation
14. Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose the patient to excessive risk or may interfere with compliance or interpretation of the study results.
15. Current receipt of, or expectation to require anti-CD20 therapy, proteasome inhibitors, intravenous immune globulin ("IVIG"), and plasma exchange therapy during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05284032
Study Brief:
Protocol Section:
NCT05284032