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

Overview

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

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

More information

Publications

Publications are currently not available
.
CLS-20199629

Mayo Clinic Footer