Actively Recruiting
A Randomized Phase III Trial Comparing Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
Led by Incyte Corporation · Updated on 2026-05-20
572
Participants Needed
30
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Incyte Corporation
Lead Sponsor
B
Blood and Marrow Transplant Clinical Trials Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two different drug combinations to prevent graft-versus-host disease (GVHD) in adults undergoing non-myeloablative or reduced intensity conditioning allogeneic peripheral blood stem cell transplantation (PBSC). The study compares the combination of Tacrolimus, Methotrexate, and Ruxolitinib with the combination of Post-Transplant Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil. This Phase III trial aims to find better ways to improve outcomes for patients receiving stem cell transplants for certain blood cancers and disorders. Participants receive one of the study drug regimens following their transplant. The experimental groups include three different doses of the Tacrolimus/Methotrexate/Ruxolitinib combination, while the active comparator group receives Post-Transplant Cyclophosphamide with Tacrolimus and Mycophenolate Mofetil. Drugs are administered by tablet or intravenous infusion as per protocol. The trial includes a dose-finding run-in period followed by the main randomized comparison of these treatment combinations. During the study, participants are closely monitored for up to 24 months after transplant to assess outcomes such as GVHD-free survival, incidence and severity of acute and chronic GVHD, time to blood cell recovery, donor cell engraftment, graft failure, relapse or progression of disease, mortality, infections, and treatment toxicities. Patient-reported outcomes including symptom scales, work productivity, and financial impact are also collected. Safety and efficacy are evaluated through regular clinical assessments and laboratory tests throughout the follow-up period.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at enrollment
- Undergoing allogeneic hematopoietic cell transplantation for acute leukemia, chronic myelogenous leukemia, myelodysplasia, chronic myelomonocytic leukemia, or specified lymphomas
- Receiving non-myeloablative or reduced intensity conditioning regimen
- Have a related or unrelated peripheral blood stem cell donor meeting specified HLA matching criteria
- Left ventricular ejection fraction of at least 45%
- Estimated glomerular filtration rate greater than 60 ml/min/1.73 m2
- Pulmonary function with DLCO corrected for hemoglobin at least 40% and FEV1 predicted at least 50%
- Liver function with AST/ALT less than 3 times upper limit of normal and total bilirubin less than 2 mg/dL
- Karnofsky Performance Score of at least 60%
- Female participants agree to use two effective contraception methods or abstain from heterosexual intercourse unless postmenopausal or surgically sterilized
- Male participants agree to use barrier contraception or abstain from heterosexual intercourse if partners of women of childbearing potential
- Disclosure of planned post-transplant maintenance therapy excluding investigational agents and hypomethylating agents
- Voluntary written informed consent obtained
You will not qualify if you...
- Prior allogeneic transplant
- Active central nervous system involvement by malignant cells
- Secondary AML arising from myeloproliferative neoplasms or overlap syndromes, except secondary AML from myelodysplastic neoplasm
- Primary, post-Essential Thrombocythemia, and post-Polycythemia Vera myelofibrosis
- Uncontrolled bacterial, viral, or fungal infections with progression or no improvement
- Active or inadequately treated latent tuberculosis infection
- Clinically significant fluid collections interfering with methotrexate use
- HIV infection with detectable viral load (undetectable viral load allowed)
- Uncontrolled hepatitis B or C virus infection (controlled cases with prophylaxis allowed)
- Recent arterial or venous thrombosis or severe uncontrolled heart conditions
- Pregnant or lactating females
- Serious medical or psychiatric illness likely to interfere with participation
- Prior malignancies except certain treated cancers
- Planned use of ATG or alemtuzumab in conditioning
- Planned prophylactic donor leukocyte infusions
- Prior use of ruxolitinib or immune checkpoint inhibitors within 6 months
- Presence of donor-specific antibodies or desensitization protocols for 7/8 HLA-matched donors
- Treatment with other investigational medicinal products during study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration as defined by protocol dosing schedules
Participants receive initial doses of Tacrolimus, Methotrexate, and Ruxolitinib to identify the appropriate dose level before starting the main treatment.
Visits according to dosing schedules
Duration - Up to 24 months post-transplant
Participants receive assigned drug regimens post-transplant: either Tacrolimus/Methotrexate/Ruxolitinib or Post-transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil to prevent graft-versus-host disease and support engraftment.
Multiple visits including baseline and follow-up visits during treatment
Duration - Up to 24 months post-transplant
Participants are monitored for outcomes such as graft-versus-host disease, relapse, survival, and treatment-related side effects after treatment ends.
Regular follow-up visits during this period
Trial Site Locations
Total: 30 locations
1
Stanford Cancer Center
Palo Alto, California, United States, 94304
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
3
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
Actively Recruiting
6
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
University of Kansas Hospital Authority
Kansas City, Kansas, United States, 66160
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
12
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
13
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
14
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
15
Memorial Sloan Kettering
New York, New York, United States, 10065
Actively Recruiting
16
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
17
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
18
Duke University Medical Center
Durham, North Carolina, United States, 27705
Actively Recruiting
19
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
20
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
21
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
22
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
23
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
24
Sarah Cannon
Nashville, Tennessee, United States, 37203
Actively Recruiting
25
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
26
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
27
Virginia Commonwealth University, North Hospital
Richmond, Virginia, United States, 23298
Actively Recruiting
28
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
29
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
30
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
I
Incyte Corporation Call Center (US)
I
Incyte Corporation Call Center (ex-US)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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