A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte… (NCT05284032) | Clinical Trial Compass
TerminatedEarly Phase 1
A Pilot Trial Using Isatuximab to Overcome Platelet Transfusion Refractoriness in Human Leukocyte Antigen Allo-Immunized Patients (SuppCare 001)
Stopped: Slow accrual
United States3 participantsStarted 2022-11-29
Plain-language summary
Some of the treatments for cancer can cause platelets (the part of the blood that helps with clotting) to decrease. If they are too low, then clinicians may recommend a transfusion (getting platelets from another person added to someone else's body). This usually works to increase the person's platelets to a healthy level, but sometimes it doesn't work. This is called platelet refractoriness. This study is trying to find out whether isatuximab (the study drug) may help people with a certain type of platelet refractoriness by removing some cells in order to make platelet transfusions more effective.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Male or female, age ≥ 18 years
✓. 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%
✓. Adequate Organ Function:
✓. For females and males of reproductive potential: agreement to use adequate contraception (see section 5.3)
✓. Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration
Exclusion criteria
✕. Immune-mediated platelet refractoriness other than anti-HLA antibody-mediated
✕. Non-immune-mediated platelet refractoriness (e.g. splenomegaly or disseminated intravascular coagulation)
What they're measuring
1
Percent panel-reactive antibodies (PRAs)- change over time/with study treatment
Timeframe: Through about 120 days following last study drug infusion