Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06615050

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)

Led by Incyte Corporation · Updated on 2026-04-16

572

Participants Needed

30

Research Sites

302 weeks

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

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

CONDITIONS

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at enrollment.
  • Undergoing allogeneic hematopoietic cell transplantation for acute leukemia, chronic myelogenous leukemia (with no circulating blasts and less than 5% blasts in bone marrow), myelodysplasia/chronic myelomonocytic leukemia (with no circulating blasts and less than 10% blasts in bone marrow), or lymphoma (specified types).
  • Planned non-myeloablative or reduced intensity conditioning regimen.
  • Have a related or unrelated peripheral blood stem cell donor meeting specified HLA matching criteria and institutional donation standards.
  • Left ventricular ejection fraction of at least 45%.
  • Estimated creatinine clearance greater than 60 ml/min.
  • 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 (excluding Gilbert's syndrome or hemolysis).
  • Karnofsky Performance Score of at least 60%.
  • Female participants must agree to use two effective contraception methods or abstain from heterosexual intercourse from consent through 15 months post-transplant unless postmenopausal or surgically sterilized.
  • Male participants must agree to use barrier contraception or abstain from heterosexual intercourse from consent through 15 months post-transplant.
  • Disclose any planned use of targeted small molecule inhibitor post-transplant maintenance therapy; investigational or hypomethylating maintenance agents are not permitted.
  • Provide voluntary written consent prior to study procedures.
Not Eligible

You will not qualify if you...

  • Prior allogeneic transplant.
  • Active central nervous system involvement by malignant cells.
  • Secondary acute myeloid leukemia arising from myeloproliferative neoplasms or overlap syndromes; secondary AML from myelodysplastic neoplasm is allowed.
  • Primary myelofibrosis.
  • Uncontrolled bacterial, viral, or fungal infections at enrollment.
  • Active or inadequately treated latent tuberculosis infection.
  • Clinically significant fluid collections interfering with methotrexate use.
  • HIV positive with detectable viral load; undetectable viral load on therapy is allowed.
  • Uncontrolled hepatitis B or C virus infection; controlled cases with undetectable viral load allowed.
  • Recent arterial or venous thrombosis within 6 months or severe heart conditions.
  • Pregnant or lactating females.
  • Serious medical or psychiatric illness interfering with study participation.
  • Prior malignancies except certain treated cancers; recent cancers require approval.
  • Planned use of ATG, alemtuzumab, or prophylactic donor leukocyte infusions.
  • Prior use of ruxolitinib or immune checkpoint inhibitors within 6 months before conditioning.
  • For 7/8 HLA-matched donors, presence of donor specific antibodies or use of desensitization protocols.
  • Treatment with any other investigational medicinal product during study treatment.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

I

Incyte Corporation Call Center (US)

CONTACT

I

Incyte Corporation Call Center (ex-US)

CONTACT

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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