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

Sponsors and collaborators