Study of Ruxolitinib in Sclerotic Chronic Graft-Versus-Host Disease After Failure of Systemic Glucocorticoids
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03616184|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : October 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Graft-versus-host-disease (GVHD)||Drug: Ruxolitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Open Label, Phase II Study of Ruxolitinib in Sclerotic Chronic Graft-Versus-Host Disease After Failure of Systemic Glucocorticoids|
|Actual Study Start Date :||September 5, 2018|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2024|
Patients will receive oral ruxolitinib at a dose of 10 mg twice daily.
Patients with sclerotic chronic graft-versus-host disease (GVHD) will receive oral ruxolitinib at a dose of 10 mg twice daily. Doses may not exceed 10 mg twice daily. Ruxolitinib will be continued for 6 months. Patients who continue to have stable disease, mixed responses or partial/complete responses at the end of 6 months may continue the drug for a total of 12 months.
- Proportion of patients with complete and partial responses in skin and/or joint [ Time Frame: 6 months ]This outcome will examine the efficacy of ruxolitinib in patients with sclerotic chronic graft-versus-host disease (GVHD) as determined by 2014 NIH Criteria.
- Proportion of patients with complete or partial responses overall [ Time Frame: 6 months ]As determined by 2014 NIH Criteria.
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): NCT03616184
|Contact: Denise Kreski, M.A.||firstname.lastname@example.org|
|Contact: April Winchester, B.S.||email@example.com|
|United States, Nebraska|
|University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68198|
|Contact: Penny Nurse Coordinator, RN 402-559-4596|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Betty Hamilton, MD|
|Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Ayman Saad, MD, MSc|
|United States, Washington|
|Fred Hutchinson Cancer Research Center||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Stephanie J Lee, MD|
|Principal Investigator:||Vijaya Bhatt, M.D.||University of Nebraska|