NCT01927731

Eltrombopag Olamine in Increasing Platelet Counts in Patients Undergoing Transplant

Safety and Efficacy of Eltrombopag in Patients Undergoing Cord Blood or Haploidentical Bone Marrow Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well eltrombopag olamine works in increasing platelet counts in patients undergoing transplant. Eltrombopag olamine may help platelet counts and the immune system recover from blood or bone marrow transplant.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the rate of platelet engraftment by day 60 in patients undergoing cord blood transplant (CBT) or haploidentical donor stem cell transplantation treated with eltrombopag (eltrombopag olamine). SECONDARY OBJECTIVES: I. To assess safety of eltrombopag in this population. II. To assess neutrophil engraftment with eltrombopag in this population. III. To characterize immune reconstitution. IV. To assess overall survival (OS). V. To assess progression free survival (PFS). VI. To assess incidence of acute graft-versus-host disease (GVHD). OUTLINE: Patients are assigned to 1 of 2 arms. ARM I (CORD BLOOD TRANSPLANT): Patients receive eltrombopag olamine orally (PO) once daily (QD) for 60 days beginning on day -1. ARM II (HAPLOIDENTICAL DONOR STEM CELL TRANSPLANT): Patients receive eltrombopag olamine PO QD for 60 days beginning on day 5. After completion of study treatment, patients are followed up at 1, 2, 3, 6, and 12 months.

Conditions

• Bone Marrow Transplantation Recipient
• Cord Blood Transplant Recipient
• Hematopoietic Cell Transplantation Recipient

Interventions

Type	Name	Description
DRUG	Eltrombopag Olamine	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2013-10-14
• Primary completion: 2023-06-06
• Completion: 2023-06-06
• First posted: 2013-08-23
• Last updated: 2024-04-23
• Results posted: 2024-04-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study