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Isatuximab for Immune Cytopenia After Stem Cell Transplant
Study Summary
This trial seeks to find out if isatuximab can help people with ICs after allo-HCT.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 307 Patients • NCT02990338Trial Design
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Who is running the clinical trial?
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- I am able to understand and follow the study's requirements.I am HIV positive or have an active hepatitis infection.My organs are functioning well.My condition didn't improve after trying at least 2 treatments including steroids, IVIG, or rituximab.I do not have any uncontrolled health conditions that pose a high risk.My cancer returned or worsened after a stem cell transplant.I am 18 years old or older.My disease is in remission after a stem cell transplant.I have been diagnosed with immune conditions like AIHA, ITP, or PRCA.My previous treatment did not fully work on my condition.I do not have an active hepatitis infection nor am I being treated for one.I agree not to donate sperm and to use birth control.I cannot take certain medications due to adverse reactions.I have anemia or low platelet count due to a complication after a transplant.I am currently receiving treatment for severe graft-versus-host disease.I am not pregnant and agree to use birth control.I had a stem cell transplant from a donor more than 45 days ago.
- Group 1: Participants with Refractory Immune Cytopenias
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has the FDA officially sanctioned treatments for Immune Cytopenias that have been resistant to therapies?
"As this Phase 2 trial has generated some data to support safety, but no evidence of efficacy, our team at Power estimates the safety of Participants with Refractory Immune Cytopenias to be a score of 2."
How widespread is the implementation of this experiment?
"Patient recruitment is currently underway at 7 sites, with four of these located in Middletown, Montvale and Commack. For convenience's sake, it would be advisable to select the site closest to you when enrolling for this study."
Are there any open spots available to partake in this investigation?
"Clinicialtrials.gov reports that this clinical trial, originally posted on May 29th 2023 and edited lastly on the 15th of May, is no longer recruiting patients. Fortunately, 628 other medical trials are currently in need of participants."
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