OSU-19328

About this trial

Last updated 4 years ago

Study ID

OSU-19328

Status

Withdrawn

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 2 years ago

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.

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

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