A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

The researchers are doing this study to compare 2 different GVHD prevention (prophylaxis) approaches. The researchers will see which approach is good or more effective at preventing chronic GVHD until 1 year after allogeneic hematopoietic stem cell transplantation (allo-HCT).

Eligibility criteria

Qualifiers

Patients ≥18- years-old at time of consent

Diagnosis: hematologic malignancy in morphologic remission (blasts <5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed. Patients with lymphoma must have a complete or partial response

Donor: related or unrelated 7-8/8 HLA-matched or related haploidentical

Karnofsky score ≥ 70%

Disqualifiers

Recipient of CD34+ selected or engineered stem cell graft

Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)

Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ

Severely impaired renal function defined by serum creatinine > 2mg/dL, renal dialysis requirement.

Trial design

Treatments tested in this trial

  • Cyclophosphamide
  • Cyclophosphamide
  • Mycophenolate Mofetil
  • Ruxolitinib
  • Tacrolimus
  • Tacrolimus

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

7
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920, Basking RidgeNew Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748, MiddletownNew Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645, MontvaleNew Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)11725, CommackNew York, United States

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

Incyte Corporation

Collaborator