A Study of INCB039110 in Combination with Corticosteroids for the Treatment of Acute Graft Versus Host Disease

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 15-007446
    NCT ID: NCT02614612
    Sponsor Protocol Number: INCB-39110-108

About this study

The purpose of this study is to determine if INCB039110 in combination with corticosteroids is safe and tolerable for treating patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Have undergone first allo-HSCT from any donor source (matched unrelated donor, sibling, haploidentical) using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies
  • Recipients of nonmyeloablative and myeloablative transplants
  • Clinically suspected Grades IIB to IVD acute GVHD as per modified MN-CIBMTR criteria, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program
  • May, but are not required to, have previously received corticosteroids for acute GVHD
  • Evidence of myeloid engraftment
    • Use of growth factor supplementation is allowed

Exclusion Criteria

  • Has received more than 1 hematopoietic stem cell transplantation
  • Has progressed on more than 2 prior treatment regimens for acute GVHD
  • Presence of an active uncontrolled infection
  • Has relapsed primary disease, or has been treated for relapse after the allogeneic hematopoietic stem-cell transplantation (allo-HSCT) was performed
  • Inadequate recovery from toxicity and/or complications from the prior allo-HSCT
  • Any corticosteroid therapy (for indications other than GVHD) at doses > 1 mg/kg per day methylprednisolone or equivalent within 7 days of randomization
  • Previously received JAK inhibitor therapy for any indication

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jeanne Palmer, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20199629

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