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Low-Dose Cyclophosphamide for Graft-versus-Host Disease
Study Summary
This trial is testing whether a lower dose of a drug called cyclophosphamide is helpful for people who undergo blood stem cell transplants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 57 Patients • NCT02440464Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- I have an active cancer that is not related to blood or skin cancer.My organs are functioning well.I have a related donor over 12 years old willing to donate and participate in research.I am 50 years or older, or I am 18-49 years old and meet specific criteria.I have a blood cancer that requires a stem cell transplant.I, or my legal guardian, can understand and agree to sign the consent form.
- Group 1: Phase I Dose De-escalation (Matched HCT)
- Group 2: Phase I Pilot for Comparative Data (Matched HCT)
- Group 3: Phase II Efficacy (Haplo HCT)
- Group 4: Phase II Efficacy (Matched HCT)
- Group 5: Donors (Haplo HCT)
- Group 6: Donors (Matched HCT)
- Group 7: Phase I Dose De-escalation (Haplo HCT)
- Group 8: Phase I Pilot for Comparative Data (Haplo HCT)
- 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
What are the main intentions of this research project?
"This clinical trial, which will be closely monitored over the course of a year, seeks to find the lowest effective dose of PTCy in combination with sirolimus and mycophenolate mofetil as GVHD prophylaxis after reduced intensity conditioning and PBSCT. The primary goal is to assess for primary graft failure AND Grade III-IV acute GVHD. Secondary objectives include estimating rates of any chronic GVHD and moderate/severe chronic GVHD at one year, describing and characterizing cytokine release syndrome (CRS) incidence, frequency and severity as well as measuring symptomatic BK virus"
What is the sample size of participants in this experiment?
"Affirmative. According to the information published on clinicaltrials.gov, this research is actively recruiting for participants and was initially posted on November 18th 2022 with a most recent update occurring on 23rd of the same month. There are 220 prospective patients that need to be recruited from one site of operation."
Are there any vacant slots available to participate in this research?
"The study is recruiting, with initial postings on the 18th of November 2022 and recent edits made on the 23rd. This information can be found at clinicaltrials.gov."
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