This phase I trial studies the side effects and best dose of romiplostim in treating patients with slow platelet recovery after umbilical cord blood transplant. Romiplostim may help increase and maintain platelet counts in patients whose platelet counts have not recovered after umbilical cord blood transplant.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02046291.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of romiplostim in patients who have failed to achieve platelet engraftment by day +28 after a myeloablative or nonmyeloablative umbilical cord blood transplant (UCBT).
SECONDARY OBJECTIVES:
I. To determine whether administration of romiplostim after UCBT influences the speed of platelet recovery in patients who have failed to achieve platelet engraftment by day +28 post-transplant.
II. To determine whether administration of romiplostim after UCBT influences the consequences of thrombocytopenia (clinically significant bleeding episodes, number of platelet transfusions).
III. To determine if administration of romiplostim in the post UCBT setting affects the incidence of bone marrow fibrosis.
TERTIARY OBJECTIVES:
I. To determine if administration of romiplostim after UCBT affects the number of bone marrow hematopoietic precursors and colony forming units.
OUTLINE: This is a dose-escalation study.
Beginning 28-42 days post-transplant, patients receive romiplostim subcutaneously (SC) once weekly for 6 weeks unless platelet count exceeds 100 x 10^9/L and at least 4 doses were given.
After completion of study treatment, patients are followed up weekly for 2 weeks and at 6 months and 1 year.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorAngela Renee Smith
