GVHD

A study of ruxolitinib vs best available therapy (BAT) in patients with steroid-refractory chronic graft vs. host disease (GvHD) after bone marrow transplantation (REACH3)

Incyte Study ID:
INCB 18424-365 (REACH3)
CT.gov ID:
NCT03112603
View Results Summary
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Results Available

Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
Available Languages: English
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Clinical Study Purpose

The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).

Clinical Study Summary

MEDICAL CONDITION(S)
  • GVHD
    • PRODUCT
  • Drug: Ruxolitinib
  • Drug: Extracorporeal photopheresis (ECP)
  • Drug: Low-dose methotrexate (MTX)
  • Drug: Mycophenolate mofetil (MMF)
  • Drug: mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus)
  • Drug: Infliximab
  • Drug: Rituximab
  • Drug: Pentostatin
  • Drug: Imatinib
  • Drug: Ibrutinib
    • COLLABORATORS
    N/A
    DATE
    Jun 2017 - May 2020
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    12+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    Incyte Investigative Site
    Tucson, Arizona, US, 85724
    Name
    Incyte Investigative Site
    Duarte, California, US, 31010
    Name
    Incyte Investigative Site
    La Jolla, California, US, 92093-0987
    Name
    Incyte Investigative Site
    Los Angeles, California, US, 90033
    Name
    Incyte Investigative Site
    New Haven, Connecticut, US, 06510
    Name
    Incyte Investigative Site
    Wilmington, Delaware, US, 19803

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Have undergone allogeneic stem cell transplantation (alloSCT) from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible
    • Evident myeloid and platelet engraftment: Absolute neutrophil count (ANC) > 1000/mm^3 and platelet count > 25,000/ mm^3

    Exclusion Criteria

    • Participants who have received 2 or more systemic treatment for cGvHD in addition to corticosteroids ± CNI for cGvHD
    • Patients that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment

    Protocol Summary

    Incyte Study ID:
    INCB 18424-365 (REACH3)
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    330
    Primary Outcome
    Open

    Efficacy of ruxolitinib versus investigator's choice best available therapy (BAT) in participants with moderate or severe SR-cGvHD assessed by overall response rate (ORR) at the Cycle 7 Day 1 visit

    Timeframe: Cycle 7 Day 1 (from baseline to Day 168)

    Secondary Outcome
    Open

    Rate of failure-free survival (FFS)

    Timeframe: From baseline to end of study treatment, up to 36 months

    Change in the modified Lee cGvHD symptom scale score

    Timeframe: Cycle 7 Day 1 (from baseline to Day 168)

    Best overall response (BOR)

    Timeframe: From baseline to crossover or end of treatment up to 36 months

    ORR at end of Cycle 3

    Timeframe: Cycle 4 Day 1 (from baseline to Day 84)

    Duration of response

    Timeframe: Time from first response until GvHD progression or death, up to approximately 36 months

    Overall survival (OS)

    Timeframe: From the date of randomization to the date of death due to any cause up to approximately 36 months.

    Cumulative incidence of non-relapse mortality (NRM)

    Timeframe: Months 1, 2, 6, 12, 18, and 24

    Percentage of participants with ≥ 50% reduction in daily corticosteroid dose at Cycle 7 Day 1

    Timeframe: Cycle 7 Day 1 (from baseline to Day 168)

    Percentage of participants successfully tapered off all corticosteroids at Cycle 7 Day 1

    Timeframe: Cycle 7 Day 1 (from baseline to Day 168)

    Cumulative incidence of malignancy relapse/recurrence (MR)

    Timeframe: At 3, 6, 12, 18, and 24 months

    Changes in Functional Assessment of Cancer therapy – Bone Marrow Transplantation (FACT-BMT)

    Timeframe: From baseline to end of treatment, up to 36 months

    Changes in EQ-5D

    Timeframe: From baseline to end of treatment, up to 36 months

    Incidence and severity of adverse events

    Timeframe: From baseline to 30-35 days after end of treatment, up to approximately 36 months

    Pharmacokinetics Parameter : Cmax of ruxolitinib

    Timeframe: Cycle 1 Day 1 and Day 15

    Pharmacokinetics Parameter : AUC last of ruxolitinib

    Timeframe: Cycle 1 Day 1 and Day 15

    Pharmacokinetics Parameter : AUCinf of ruxolitinib

    Timeframe: Cycle 1 Day 1 and Day 15

    Pharmacokinetics Parameter : CL/F of ruxolitinib

    Timeframe: Cycle 1 Day 1 and Day 15

    Pharmacokinetics Parameter : Vz/F of ruxolitinib

    Timeframe: Cycle 1 Day 1 and Day 15

    Pharmacokinetics Parameter : Tmax of ruxolitinib

    Timeframe: Cycle 1 Day 1 and Day 15

    Pharmacokinetics Parameter : T1/2 of ruxolitinib

    Timeframe: Cycle 1 Day 1 and Day 15

    Utilization of Medical Resources

    Timeframe: 36 months