New drug cocktail aims to tame deadly transplant complication

NCT ID NCT06615050

Recruiting now Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

First seen Nov 01, 2025 · Last updated Jun 23, 2026 · Updated 36 times

Summary

This phase 3 trial compares two drug combinations given after a stem cell transplant to prevent graft-versus-host disease (GVHD), a serious complication where donor cells attack the patient's body. The study will enroll 572 adults with blood cancers like leukemia or myelodysplasia. One group gets tacrolimus, methotrexate, and ruxolitinib; the other gets cyclophosphamide, tacrolimus, and mycophenolate mofetil. The goal is to see which combination better prevents severe GVHD and improves survival.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Study contacts

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Locations

Baylor College of Medicine
RECRUITING

Houston, Texas, 77030, United States
Blood and Marrow Transplant Group of Georgia
RECRUITING

Atlanta, Georgia, 30342, United States
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Dana Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Duke University Medical Center
RECRUITING

Durham, North Carolina, 27705, United States
Fred Hutchinson Cancer Research Center
RECRUITING

Seattle, Washington, 98109, United States
Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48202, United States
Indiana University Cancer Center
RECRUITING

Indianapolis, Indiana, 46202, United States
Karmanos Cancer Institute
RECRUITING

Detroit, Michigan, 48201, United States
Levine Cancer Institute
RECRUITING

Charlotte, North Carolina, 28204, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
Memorial Sloan Kettering
RECRUITING

New York, New York, 10065, United States
Moffitt Cancer Center
RECRUITING

Tampa, Florida, 33612, United States
Mount Sinai Hospital
RECRUITING

New York, New York, 10029, United States
Ohio State University
RECRUITING

Columbus, Ohio, 43210, United States
Oregon Health & Science University
RECRUITING

Portland, Oregon, 97239, United States
Sarah Cannon
RECRUITING

Nashville, Tennessee, 37203, United States
Stanford Cancer Center
RECRUITING

Palo Alto, California, 94304, United States
University of California San Francisco
RECRUITING

San Francisco, California, 94158, United States
University of Kansas Hospital Authority
RECRUITING

Kansas City, Kansas, 66160, United States
University of Miami
RECRUITING

Miami, Florida, 33136, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of North Carolina At Chapel Hill
RECRUITING

Chapel Hill, North Carolina, 27514, United States
University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
University of Wisconsin
RECRUITING

Madison, Wisconsin, 53705, United States
Vanderbilt Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States
Virginia Commonwealth University, North Hospital
RECRUITING

Richmond, Virginia, 23298, United States
Washington University
RECRUITING

St Louis, Missouri, 63110, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

Tacrolimus, Methotrexate, Ruxolitinib, Cyclophosphamide, Mycophenolate mofetil

What this could lead to

If successful, this could identify a better drug combination to prevent severe graft-versus-host disease after stem cell transplant, improving survival and quality of life.

What could go wrong

This is a large phase 3 trial, but the new combination may not be better than the standard one. Both regimens have significant side effects, including infection and organ damage.

Conditions

The condition(s) this trial relates to.

acute leukemia anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma Bronchiolitis Obliterans Syndrome chronic myelogenous leukemia, BCR-ABL1 positive chronic myelomonocytic leukemia diffuse large B-cell lymphoma follicular lymphoma graft versus host disease Hodgkins lymphoma mantle cell lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma myelodysplastic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GRAFT-VERSUS-HOST DISEASE (GVHD)