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

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18.0 years or older at the time of enrollment.

• Participants undergoing allogeneic HCT for one of the following indications:

‣ Acute leukemia or chronic myelogenous leukemia with no circulating blasts and with less than 5% blasts in the bone marrow. Therapy related myeloid neoplasms are allowed.

⁃ Myelodysplasia/chronic myelomonocytic leukemia with no circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \< 5% versus 5-10% blasts in this disease). Therapy related myeloid neoplasms are allowed.

⁃ Lymphoma \[follicular lymphoma, Hodgkin lymphoma, diffuse large B cell lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma and anaplastic large cell lymphoma\].

• Planned NMA/reduced intensity conditioning regimen.

• Participants must have a related or unrelated PBSC donor as follows:

‣ Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation. HLA-matched parents and children may be used as donors.

⁃ Unrelated donor must be a 7/8 or 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donor must be willing to donate peripheral blood stem cells and meet NMDP criteria for donation.

⁃ Donor selection must comply with 21 CFR 1271.

• Cardiac function: Left ventricular ejection fraction at least 45%.

• Estimated creatinine clearance greater than 60 ml/min using the 2021 CKD-EPI formula or 24-hour urine creatinine clearance.

• Pulmonary function: DLCO corrected for hemoglobin at least 40% and FEV1 predicted at least 50%.

• Liver function: AST/ALT \< 3x ULN; Total bilirubin \< 2 mg/dL excluding Gilbert's syndrome or hemolysis.

• Karnofsky Performance Score of at least 60%.

• Female participants (unless postmenopausal for at least one year before the screening visit, or surgically sterilized), agree to practice two effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse, from the time of signing the informed consent through 15 months post-transplant. Fertility preservation methods will be left to institutional standards.

• Male participants (even if surgically sterilized), of partners of women of childbearing potential must agree to one of the following: practice effective barrier contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 15 months post-transplant.

• Plans for the use of targeted small molecule inhibitor post-transplant maintenance therapy must be disclosed upon enrollment and must be used irrespective of the outcome of the randomization. Planned use of investigational maintenance agents is not permitted. Planned hypomethylating agents as maintenance therapy is not permitted.

• Voluntary written consent obtained prior to the performance of any study-related procedure that is not a part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.

Locations
United States
California
Stanford Cancer Center
RECRUITING
Palo Alto
Florida
University of Miami
RECRUITING
Miami
Moffitt Cancer Center
RECRUITING
Tampa
Georgia
Blood and Marrow Transplant Group of Georgia
RECRUITING
Atlanta
Indiana
Indiana University Cancer Center
RECRUITING
Indianapolis
Kansas
University of Kansas Hospital Authority
RECRUITING
Kansas City
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
Karmanos Cancer Institute
RECRUITING
Detroit
Missouri
Washington University
RECRUITING
St Louis
North Carolina
University of North Carolina At Chapel Hill
RECRUITING
Chapel Hill
Levine Cancer Institute
RECRUITING
Charlotte
Duke University Medical Center
RECRUITING
Durham
New York
Memorial Sloan Kettering
RECRUITING
New York
Mount Sinai Hospital
RECRUITING
New York
Ohio
Ohio State University
RECRUITING
Columbus
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Vanderbilt Medical Center
RECRUITING
Nashville
Texas
Baylor College of Medicine
RECRUITING
Houston
Virginia
Virginia Commonwealth University, North Hospital
RECRUITING
Richmond
Washington
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Wisconsin
University of Wisconsin
RECRUITING
Madison
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date: 2025-04-02
Estimated Completion Date: 2031-01-17
Participants
Target number of participants: 572
Treatments
Experimental: Dose Finding Run-In Group 1: Tac/MTX/Ruxolitnib Dose 1
Tacrolimus/ methotrexate/ ruxolitinib (Tac/MTX/Rux) at the protocol defined doses.
Experimental: Dose Finding Run-In Group 2: Tac/MTX/Ruxolitnib Dose 2
Tacrolimus/ methotrexate/ ruxolitinib (Tac/MTX/Rux) at the protocol defined doses.
Experimental: Main Study Group A: Tac/MTX/Ruxolitnib
Tacrolimus/ methotrexate/ ruxolitinib (Tac/MTX/Rux) at the protocol defined doses.
Active_comparator: Main Study Group B: PTCy/Tac/MMF
Post-transplant cyclophosphamide/ tacrolimus/ mycophenolate mofetil (PTCy/Tac/MMF) at the protocol defined doses.
Sponsors
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network
Leads: Incyte Corporation

This content was sourced from clinicaltrials.gov