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Alkylating agents
Cyclophosphamide + Ruxolitinib for Graft-versus-Host Disease Prophylaxis
Phase 2
Recruiting
Led By Sameem Abedin, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year after hct
Awards & highlights
Study Summary
This trial looks at safety/effectiveness of low-dose drug to prevent transplant-related side effects in older adults getting a stem cell transplant.
Who is the study for?
Adults with certain blood cancers who are in remission can join this trial if they have a matched stem cell donor and meet health criteria like good performance status, normal organ function, and no recent other cancers. They must agree to contraception use.Check my eligibility
What is being tested?
The study tests a combination of low-dose Cyclophosphamide (PTCy) and Ruxolitinib for preventing GVHD in older adults receiving stem cell transplants from matched donors, using reduced intensity conditioning therapy.See study design
What are the potential side effects?
Possible side effects include immune system suppression leading to increased infection risk, bleeding complications, liver toxicity, gastrointestinal issues such as nausea or diarrhea, and potential drug-specific reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year after hct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year after hct
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of subjects who experience GVHD-free survival.
Secondary outcome measures
Overall survival at one year.
The number of subjects with acute GVHD at Day +100.
The number of subjects with acute GVHD at Day +180.
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Graft-versus-host disease prophylaxisExperimental Treatment4 Interventions
Following reduced intensity conditioning and 8/8-matched peripheral blood transplant on Day 0, all patients will receive a GVHD prophylaxis post-transplant composed of the following: (i) cyclophosphamide administered at 25 mg/kg on Day +3 and +4, (ii) tacrolimus beginning on Day +5 and through Day +180 and administered with a trough target of 5-10 ng/ml through Day +90 and tapered thereafter; (iii) mycophenolate mofetil (MMF) administered at 15 mg/kg thrice daily beginning on Day +5 through Day +35; and (iv) ruxolitinib administered at 5 mg twice daily starting after engraftment (between Days +30 and +60) and continuing through one year post transplant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Tacrolimus
2011
Completed Phase 4
~4740
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,527 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
Sameem Abedin, MDPrincipal InvestigatorMedical College of Wisconsin
4 Previous Clinical Trials
10,056 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a milder form of pre-transplant treatment.My lung function tests are below 50% of what's expected.I have had a bone marrow transplant or CAR-T cell therapy before.I have a stem cell donor who is a perfect match for me.I haven't had any cancer except for certain skin cancers or early cervical changes in the last year.I need ongoing treatment for a chronic or active infection.My bilirubin levels are high, but I don't have Gilbert syndrome.My blood cancer is currently in remission.My kidney function is normal or only slightly impaired.I can care for myself but may need occasional help.My heart's pumping ability is reduced.I agree to use barrier methods of contraception or practice abstinence during the study.I am not pregnant and agree to use two forms of birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Graft-versus-host disease prophylaxis
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.
Has the FDA sanctioned any preventative measures against Graft-versus-host disease?
"Due to the limited evidence of efficacy, Graft-versus-host disease prophylaxis received an appraisal score of 2 for safety."
Answered by AI
Are there any vacancies available for individuals to participate in this trial?
"According to the data available on clinicaltrials.gov, enrollment for this particular medical trial has been closed since November 11th 2022. While not recruiting anymore, there are 169 other studies actively seeking participants at this time."
Answered by AI
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