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Dose escalation phase: Dose level 0 for Graft-versus-Host Disease
Phase 1
Waitlist Available
Led By Mitchell Horwitz, MD
Research Sponsored by Stefanie Sarantopoulos, MD, PhD.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have undergone allogeneic hematopoietic cell transplantation (HCT) from any donor source (matched unrelated donor, sibling, haploidentical) using bone marrow, peripheral blood, or cord blood stem cells
Patients with clinically diagnosed cGvHD staging of mild to severe according to NIH Consensus Criteria prior to Cycle 1 Day 1 and with confirmed steroid refractoriness or steroid dependence irrespective of the concomitant use of a calcineurin inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a combination of two medications, fostamatinib and ruxolitinib, for the treatment of chronic GvHD. The goal is to find the safest and most effective
Who is the study for?
This trial is for individuals with chronic Graft-versus-Host Disease (cGVHD) who haven't responded well to steroids. Participants should have specific conditions like Bronchiolitis Obliterans Syndrome and be able to receive both Ruxolitinib and Fostamatinib.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining two drugs, Ruxolitinib and Fostamatinib, for cGVHD patients not responding to steroids. It starts by finding a safe dose before expanding to more patients who will help determine the best dose for future studies.See study design
What are the potential side effects?
Possible side effects from Ruxolitinib may include infections, low blood counts, dizziness, or headaches. Fostamatinib might cause high blood pressure, diarrhea, nausea, or liver enzyme elevations. The combination's side effects will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received a stem cell transplant from a donor.
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I have chronic GvHD that's not responding well to steroids, regardless of other treatments.
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I am 18 years old or older.
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My blood tests show enough neutrophils, platelets, and hemoglobin.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Minimum safe and biologically effective dose as determined by 6-month overall response rate
Minimum safe and biologically effective dose as determined by dose-limiting toxicities
Minimum safe and biologically effective dose as determined by pharmacodynamic results
+1 moreSecondary outcome measures
1-year cGvHD-free survival
Duration of Response
Overall response rate
+1 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Dose escalation phase: Dose level 3Experimental Treatment2 Interventions
Fostamatinib at dose level 3 (dose of 100mg BID) in combination with standard of care ruxolitinib 10mg BID
Group II: Dose escalation phase: Dose level 2Experimental Treatment2 Interventions
Fostamatinib at dose level 2 (dose of 150mg QAM) in combination with standard of care ruxolitinib 10mg BID
Group III: Dose escalation phase: Dose level 1Experimental Treatment2 Interventions
Fostamatinib at dose level 1 (dose of 100mg QAM) in combination with standard of care ruxolitinib 10mg BID
Group IV: Dose escalation phase: Dose level 0Experimental Treatment2 Interventions
Fostamatinib at dose level 0 (dose of 50mg QAM) in combination with standard of care ruxolitinib 10mg BID
Group V: Candidate Dose #2Experimental Treatment2 Interventions
In the safety expansion cohort, subjects will be randomized to one of two candidate doses of fostamatinib (identified from the dose escalation phase) in combination with ruxolitinib 10mg BID.
Group VI: Candidate Dose #1Experimental Treatment2 Interventions
In the safety expansion cohort, subjects will be randomized to one of two candidate doses of fostamatinib (identified from the dose escalation phase) in combination with ruxolitinib 10mg BID.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Fostamatinib
2010
Completed Phase 3
~1510
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Who is running the clinical trial?
Stefanie Sarantopoulos, MD, PhD.Lead Sponsor
1 Previous Clinical Trials
22 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
368 Previous Clinical Trials
55,431 Total Patients Enrolled
Rigel PharmaceuticalsIndustry Sponsor
31 Previous Clinical Trials
3,818 Total Patients Enrolled
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