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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    27
  • sponsor
    Basem William, MD
Updated on 15 December 2021
platelet count
thrombocytopenia
hematopoietic stem cell transplant

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.

Description

PRIMARY OBJECTIVE:

I. To determine the safety and efficacy of avatrombopag for the treatment of thrombocytopenia after allogenic hematopoietic stem cell transplantation.

SECONDARY OBJECTIVE:

I. To identify predictors of response to avatrombopag.

OUTLINE

Patients receive avatrombopag orally (PO) once daily (QD) for up to 1 year in the absence of disease progression or unacceptable toxicity. Avatrombopag will be titrated weekly until platelet count of greater than or equal to 60,000/uL is achieved and persists for 7 consecutive days, and the patient remains free from platelet transfusion.

After completion of study treatment, patients are followed up weekly for 4 weeks and then monthly up to 1 year.

Details
Condition Thrombocytopathy, Platelet Disorders, Platelet Deficiencies, Platelet Deficiencies, Platelet Disorders
Treatment Avatrombopag
Clinical Study IdentifierNCT04312789
SponsorBasem William, MD
Last Modified on15 December 2021

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