This phase II trial tests how well ruxolitinib as a maintenance medication works to prevent relapse and graft-versus-host disease (GVHD) for patients who have undergone stem cell transplantation for T-cell lymphoma. GVHD is a common problem that may occur after a blood stem cell transplant. The "graft" is the donor blood cells that patients get during the transplant. The "host" is the person receiving the cells. GVHD is when the donor graft attacks and damages some of the transplant recipient's tissues. Ruxolitinib is a type of drug called a Janus kinase (JAK) inhibitor which works by decreasing the immune response of cells in the body. It is also a cancer growth blocker that blocks the growth factors that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene, called JAK2, that is important in the production of cancer cells.
Adult patients with T-cell lymphoma [PTCL (all subtypes), T-PLL, ATLL, and CTCL (all subtypes)] in partial or complete remission between day +35 and +120 from auto-SCT or allo-SCT
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
Adequate hematologic function defined by absolute neutrophil count (ANC) > 1000/mm3 without granulocyte colony-stimulating factor (G-CSF) for at least 3 days, platelets > 50K/mm3 without transfusion for at least 3 days and hemoglobin (Hb) > 8.0 g/dL without transfusion for at least 3 days.
Adequate organ function defined by total Bilirubin < 1.5 x ULN, alanine aminotransferase (ALT) </= 3 x ULN, CKD-EPI eGFR ≥ 30 ml/min, SpO2 > 92% without supplemental oxygen.
Anaplastic lymphoma kinase (ALK)+ or Dual specificity 22 (DUSP22)+ ALCL with low international prognostic index (IPI) score (<2) in first complete remission.
Progressive disease or any other systemic therapy post-SCT (radiation allowed)
Disease progression to Ruxolitinib previously
GvHD requiring systemic therapy.
Jonathan Brammer
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Incyte Corporation
Collaborator