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RECRUITING
NCT06615050
PHASE3

A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Official title: A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

572

Start Date

2025-04-02

Completion Date

2031-01-17

Last Updated

2025-12-16

Healthy Volunteers

No

Interventions

DRUG

Tacrolimus (Tac)

Tablet or intravenously (IV)

DRUG

Methotrexate (MTX)

Intravenously (IV)

DRUG

Ruxolitinib (Rux)

Tablet

DRUG

Cyclophosphamide

Intravenously (IV)

DRUG

Mycophenolate mofetil (MMF)

Tablet or intravenously (IV)

Locations (28)

Stanford Cancer Center

Palo Alto, California, United States

University of California San Francisco

San Francisco, California, United States

University of Miami

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

University of Kansas Hospital Authority

Kansas City, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

Mount Sinai Hospital

New York, New York, United States

Memorial Sloan Kettering

New York, New York, United States

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt Medical Center

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

Virginia Commonwealth University, North Hospital

Richmond, Virginia, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States