GVHD

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)

Incyte Study ID:
INCB18424-370
CT.gov ID:
NCT06615050
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
Blood and Marrow Transplant Clinical Trials Network,National Institutes of Health (NIH),National Heart, Lung, and Blood Institute (NHLBI),National Cancer Institute (NCI)
Study Contact Information:
1.855.463.3463 or [email protected]
Recruiting
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Clinical Study Purpose

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

Clinical Study Summary

MEDICAL CONDITION(S)
  • GVHD
    • PRODUCT
  • Drug: Tacrolimus (Tac)
  • Drug: Methotrexate (MTX)
  • Drug: Ruxolitinib (Rux)
  • Drug: Cyclophosphamide
  • Drug: Mycophenolate mofetil (MMF)
    • COLLABORATORS
    Blood and Marrow Transplant Clinical Trials Network,National Institutes of Health (NIH),National Heart, Lung, and Blood Institute (NHLBI),National Cancer Institute (NCI)
    DATE
    Apr 2025 - Jan 2031
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18 Years - NA
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Location
    Status
    Location
    BLOOD AND MARROW TRANSPLANT GROUP OF GEORGIA
    ATLANTA, GA, US, 30342
    Status
    Recruiting
    Location
    MOUNT SINAI HOSPITAL
    NEW YORK, NY, US, 10029
    Status
    Recruiting
    Location
    HENRY FORD HOSPITAL
    DETROIT, MI, US, 48202
    Status
    Recruiting
    Location
    KARMANOS CANCER INSTITUTE
    DETROIT, MI, US, 48201
    Status
    Recruiting

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Age 18.0 years or older at the time of enrollment.
    • Participants undergoing allogeneic HCT for one of the following indications:

    Exclusion Criteria

    • Prior allogeneic transplant.
    • Active CNS involvement by malignant cells.

    Protocol Summary

    Incyte Study ID:
    INCB18424-370
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    572
    Primary Outcome
    Open

    GVHD-free survival (GFS)

    Timeframe: Up to 24 months post-transplant (Day 0)

    Secondary Outcome
    Open

    GVHD/relapse or Progression-free Survival (GRFS)

    Timeframe: Up to 24 months post-transplant (Day 0)

    Incidence of chronic GVHD

    Timeframe: Up to 24 months post-transplant (Day 0)

    Incidence of acute grade 2-4 and 3-4 graft versus host disease (GVHD)

    Timeframe: Up to 24 months post-transplant (Day 0)

    Time to neutrophil and platelet recovery

    Timeframe: Up to 24 months post-transplant (Day 0)

    Donor Cell Engraftment

    Timeframe: Up to 24 months post-transplant (Day 0)

    Cumulative incidence of primary and secondary graft failure

    Timeframe: Day 28 and up to 2 years post-transplant (Day 0)

    Disease Relapse or Progression

    Timeframe: Up to 24 months post-transplant (Day 0)

    Non-relapse Mortality

    Timeframe: Up to 24 months post-transplant (Day 0)

    Toxicity and Infections

    Timeframe: Up to 24 months post-transplant (Day 0)

    Disease-Free Survival

    Timeframe: Up to 24 months post-transplant (Day 0)

    Overall Survival

    Timeframe: Up to 24 months post-transplant (Day 0)

    Modified Lee Chronic GVHD Symptom Scale (mLSS)

    Timeframe: Up to 24 months post-transplant (Day 0)

    Individual Symptom Scale: Modified Medical Research Council (mMRC) Dyspnea scale

    Timeframe: Up to 24 months post-transplant (Day 0)

    Individual Symptom Scale: Two items from a protocol defined survey

    Timeframe: Up to 24 months post-transplant (Day 0)

    Individual Symptom Scale: Oral Health Impact Profile (OHIP)

    Timeframe: Up to 24 months post-transplant (Day 0)

    Individual Symptom Scale: Ocular Surface Disease Index (OSDI)

    Timeframe: Up to 24 months post-transplant (Day 0)

    Work Productivity and Impairment Questionnaire (WPAI)

    Timeframe: Up to 24 months post-transplant (Day 0)

    Comprehensive Score for Financial Toxicity (COST)

    Timeframe: Up to 24 months post-transplant (Day 0)

    Patient-Reported Economic, Income and Insurance Data (PREIID)

    Timeframe: Up to 24 months post-transplant (Day 0)

    Patient Reported Caregiver Assessment (PRCA)

    Timeframe: Up to 24 months post-transplant (Day 0)