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)

Part of paid clinical trials in Palo Alto, California.

Sponsor
Incyte Corporation
Study ID
NCT06615050
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Graft-versus-host Disease (GVHD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tacrolimus (Tac) — DRUG
    Tablet or intravenously (IV)
  • Methotrexate (MTX) — DRUG
    Intravenously (IV)
  • Ruxolitinib (Rux) — DRUG
    Tablet
  • Cyclophosphamide — DRUG
    Intravenously (IV)
  • Mycophenolate mofetil (MMF) — DRUG
    Tablet or intravenously (IV)

Study Details

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

Key Dates

Start date
Apr 2, 2025
Status verified
May 2026
Primary completion
Jan 17, 2031
Completion
Jan 17, 2031

Study Design

Enrollment
572 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

GVHD-free survival (GFS) [ Time Frame: Up to 24 months post-transplant (Day 0) ]

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
Stanford Cancer CenterPalo AltoCalifornia94304-
University of California San FranciscoSan FranciscoCalifornia94158-
University of MiamiMiamiFlorida33136-
Moffitt Cancer CenterTampaFlorida33612-
Blood and Marrow Transplant Group of GeorgiaAtlantaGeorgia30342-
Indiana University Cancer CenterIndianapolisIndiana46202-
University of Kansas Hospital AuthorityKansas CityKansas66160-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
Karmanos Cancer InstituteDetroitMichigan48201-
Washington UniversitySt LouisMissouri63110-
Memorial Sloan KetteringNew YorkNew York10065-
Mount Sinai HospitalNew YorkNew York10029-
University of North Carolina At Chapel HillChapel HillNorth Carolina27514-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27705-
Cleveland ClinicClevelandOhio44195-
Ohio State UniversityColumbusOhio43210-
Oregon Health & Science UniversityPortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Sarah CannonNashvilleTennessee37203-
Vanderbilt Medical CenterNashvilleTennessee37232-
Baylor College of MedicineHoustonTexas77030-
Virginia Commonwealth University, North HospitalRichmondVirginia23298-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
University of WisconsinMadisonWisconsin53705-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Palo Alto, CA

By research site
Stanford Cancer Center· Palo Alto, CAUniversity of California San Francisco· San Francisco, CAUniversity of Miami· Miami, FLMoffitt Cancer Center· Tampa, FLBlood and Marrow Transplant Group of Georgia· Atlanta, GAIndiana University Cancer Center· Indianapolis, IN

Related Studies