Avatrombopag for the Treatment of Thrombocytopenia After Donor Hematopoietic Stem Cell Transplant

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies the side effects and how well avatrombopag works for the treatment of thrombocytopenia after donor hematopoietic stem cell transplant. Thrombocytopenia is defined as abnormally low level of platelets in the blood. Avatrombopag is a small molecule thrombopoietin receptor agonist which stimulates thrombopoietin receptor leading to increase production of platelets.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Basem William, MD; Ohio State University Comprehensive Cancer Center
• Collaborators: Dova Pharmaceuticals; National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Failure to engraft platelets by day 30 (D30) after hematopoietic cell transplantation (HCT) defined as: Platelet count less than 20,000/uL and patient is still dependent on platelet transfusion support

• Patient must be able to start treatment with avatrombopag within 30-60 days following transplant

• Able to provide written informed consent from patient or legal representative

Exclusion Criteria:

• Serious uncontrolled infections

• Steroid refractory graft versus host disease (GVHD)

• Patients with thrombotic microangiopathy

• Pregnant or lactating women

• Creatinine clearance < 30 ml/min

• Active thromboembolism requiring anticoagulation

• Unable to understand the investigational nature of the study or provide informed consent

• Evidence of disease relapse by flow cytometry of chimerisms

• Concomitant use of other thrombopoietin receptor agonists (TPO-RA) medication during the treatment phase of the study or two weeks prior to enrollment