A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)
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|ClinicalTrials.gov Identifier: NCT02953678|
Recruitment Status : Active, not recruiting
First Posted : November 3, 2016
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Graft-versus-host Disease (GVHD)||Drug: Ruxolitinib Drug: Prednisone or methylprednisolone||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Cohort, Phase 2 Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)|
|Actual Study Start Date :||December 27, 2016|
|Actual Primary Completion Date :||January 31, 2018|
|Estimated Study Completion Date :||June 2020|
Experimental: Ruxolitinib in combination with corticosteroids
Participants began oral administration of ruxolitinib at 5 mg twice daily (BID); if stable after the first 3 days of treatment, the dose could be increased to 10 mg BID.
Drug: Prednisone or methylprednisolone
Either oral prednisone or IV methylprednisolone may be used to begin corticosteroid treatment at the investigator's discretion.
- Overall Response Rate (ORR) at Day 28 [ Time Frame: From baseline to Day 28 ]Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
- Six-month Duration of Response (DOR) [ Time Frame: From baseline to Day 180 ]Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. DOR was assessed when all participants who were still on study completed the Day 180 visit.
- Overall Response Rate (ORR) [ Time Frame: From baseline to days 14, 56, and 100 ]Defined as the percentage of participants demonstrating a CR, VGPR, or PR.
- Three-month Duration of Response (DOR) [ Time Frame: From baseline to 84 days ]
- Nonrelapse Mortality (NRM) [ Time Frame: From baseline to Months 6, 9, 12, and 24 ]Defined as the proportion of subjects who died due to causes other than malignancy relapse.
- Relapse Rate [ Time Frame: From baseline to Day 84 ]Defined as the percentage of participants whose underlying malignancy relapsed.
- Relapse-related Mortality Rate [ Time Frame: From baseline to Day 84 ]Defined as the percentage of participants whose malignancy relapsed and had a fatal outcome.
- Failure-free Survival (FFS) [ Time Frame: From baseline to Day 84 ]Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD).
- Overall Survival (OS) [ Time Frame: From baseline to Day 84 ]Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause.
- Incidence and Severity of Adverse Events [ Time Frame: From consent to 30-35 days after end of treatment, up to 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953678
|United States, Arizona|
|Tucson, Arizona, United States, 85719|
|United States, California|
|Duarte, California, United States, 31010|
|La Jolla, California, United States, 92903|
|Los Angeles, California, United States, 90033|
|Los Angeles, California, United States, 90095|
|Stanford, California, United States, 94306|
|United States, Colorado|
|Denver, Colorado, United States, 80218|
|United States, Florida|
|Gainesville, Florida, United States, 32610|
|Miami, Florida, United States, 33136|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Chicago, Illinois, United States, 60637|
|United States, Kentucky|
|Lexington, Kentucky, United States, 40536-0293|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Grand Rapids, Michigan, United States, 49503|
|United States, Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|New York, New York, United States, 10022|
|New York, New York, United States, 10065|
|Rochester, New York, United States, 14642|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28204|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45242|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Philadelphia, Pennsylvania, United States, 19107|
|Pittsburgh, Pennsylvania, United States, 15224|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|Dallas, Texas, United States, 75246|
|San Antonio, Texas, United States, 78229|
|United States, Utah|
|Salt Lake City, Utah, United States, 84112|
|United States, Washington|
|Seattle, Washington, United States, 98109|
|United States, West Virginia|
|Morgantown, West Virginia, United States, 26506|
|United States, Wisconsin|
|Madison, Wisconsin, United States, 53705|
|Milwaukee, Wisconsin, United States, 53226|
|Study Director:||Fitzroy Dawkins, MD||Incyte Corporation|