drugset / Trial / NCT04384692

Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis

NCT04384692 ↗

Phase 2 Active not recruiting 53 enrolled Fred Hutchinson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well administering ruxolitinib before, during, and after allogeneic hematopoietic stem cell transplantation works in preventing graft versus host disease and improving transplant outcomes in patients with primary and secondary myelofibrosis. Donor hematopoietic stem cell transplantation (HSCT) is currently the only treatment with proven curative potential for myelofibrosis, however, myelofibrosis patients have a high risk for developing graft versus host disease post-transplant. Graft versus host disease is a condition where the transplanted cells from a donor can attack the body's normal cells. Ruxolitinib, a janus-associated kinase (JAK) inhibitor, is known to decrease inflammatory signals, which may reduce spleen size and decrease symptoms such as night sweats and weight loss. Administering ruxolitinib before, during, and after transplant may decrease the incidence and severity of graft versus host disease, increase survival, and improve quality of life in patients with primary and secondary myelofibrosis.

Timeline

Start
2020-12-18
Primary completion
2026-04-03
Completion
2030-04-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Ruxolitinib Small molecule — Oral
Background Busulfan Small molecule — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous
Background Melphalan Small molecule — Intravenous
Background Methotrexate Small molecule — Intravenous
Background Mycophenolate Mofetil Small molecule — Intravenous
Background Tacrolimus Small molecule — Intravenous