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Monoclonal Antibodies
Isatuximab for Platelet Transfusion Issues
Phase < 1
Recruiting
Research Sponsored by Firas El Chaer, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate Organ Function: serum creatinine <= 1.5 x upper limit of normal
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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through about 120 days following last study drug infusion
Awards & highlights
Study Summary
This trial is testing a drug to see if it can help people with a certain type of platelet refractoriness by removing some cells in order to make platelet transfusions more effective.
Who is the study for?
Adults with blood cancers who have immune-mediated platelet transfusion refractoriness due to class I anti-HLA antibodies can join this trial. They must be over 18, have good organ function, and agree to use contraception. People with certain infections, allergies to the study drug's components, or other causes of low platelets cannot participate.Check my eligibility
What is being tested?
The trial is testing if isatuximab can help overcome platelet transfusion refractoriness in patients whose bodies reject donor platelets despite needing them for clotting due to their blood cancer treatment.See study design
What are the potential side effects?
Possible side effects of isatuximab include allergic reactions, potential impact on liver enzymes (AST/ALT), and other infusion-related reactions. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine, is within the normal range.
Select...
I have been diagnosed with a condition where my body rejects platelet transfusions due to certain antibodies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through about 120 days following last study drug infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through about 120 days following last study drug infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent panel-reactive antibodies (PRAs)- change over time/with study treatment
Secondary outcome measures
Adverse events
Mean fluorescence intensity (MFI) - change over time/ with study treatment
Quality of life - changes over time/with study treatment according to the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Isatuximab (Sarclisa)Experimental Treatment1 Intervention
4 weekly doses of isatuximab
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Who is running the clinical trial?
Firas El Chaer, MDLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by creatinine, is within the normal range.I have previously received treatments targeting CD38.I am currently fighting a severe infection that needs strong IV antibiotics.I have been diagnosed with a condition where my body rejects platelet transfusions due to certain antibodies.I do not have uncontrolled HIV or active hepatitis.I am currently experiencing active bleeding.My low platelet count is not due to anti-HLA antibodies.I have been diagnosed with TTP or ITP.I have low platelet counts due to medications like vancomycin, heparin, or amphotericin.My low platelet count is not due to an immune system problem.I had a stem cell transplant from a donor with a different blood type.I have an infection under control with medication.I am 18 years old or older.I have severe symptoms from a transplant complication.I am currently receiving or expected to need treatments like anti-CD20, proteasome inhibitors, IVIG, or plasma exchange.
Research Study Groups:
This trial has the following groups:- Group 1: Isatuximab (Sarclisa)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit of individuals participating in this experiment?
"Confirmed. Clinicaltrials.gov states that the medical trial, which was initiated on November 4th 2022, is presently recruiting individuals to participate in it. 17 patients are required across 2 sites for this study."
Answered by AI
Are there still openings for participants to join this clinical trial?
"Confirmed. According to clinicaltrials.gov, this trial is actively enrolling 17 participants from two sites and was initially posted on November 4th 2022 with the most recent edit occurring on that same day."
Answered by AI
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