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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 more

Secondary outcome measures

1-year cGvHD-free survival

Duration of Response

Overall response rate

+1 more

Trial 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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stefanie Sarantopoulos, MD, PhD.Lead Sponsor

1 Previous Clinical Trials

22 Total Patients Enrolled

Incyte CorporationIndustry Sponsor

364 Previous Clinical Trials

55,135 Total Patients Enrolled

Rigel PharmaceuticalsIndustry Sponsor

31 Previous Clinical Trials

3,818 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 45 eligible to participate in this clinical trial?

"Prospective participants for this clinical trial must be within the age range of 18 to 80 years. Notably, there are a total of 60 studies available specifically for individuals below the age of 18 and an additional 134 studies tailored towards patients above the age of 65."

Answered by AI

Are new patients currently being enrolled in this ongoing medical study?

"According to clinicaltrials.gov, the recruitment phase for this particular clinical trial has concluded. The trial was initially posted on June 1st, 2024 and last updated on January 22nd, 2024. However, there are currently 159 other trials actively seeking participants at present."

Answered by AI

To what extent can individuals be harmed by the initial phase of dose escalation, specifically at level 0?

"Based on the current evaluation from our team at Power, we assign a safety score of 1 to Dose escalation phase: Dose level 0. This assessment is due to it being a Phase 1 trial where there is limited available data supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD

Stefanie Sarantopoulos, MD, PhD. 2024. "Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06233110.

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