Avatrombopag for the Treatment of Thrombocytopenia After Donor Hematopoietic Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT04312789|
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Platelet Disorder||Drug: Avatrombopag||Phase 2|
I. To determine the safety and efficacy of avatrombopag for the treatment of thrombocytopenia after allogenic hematopoietic stem cell transplantation.
I. To identify predictors of response to avatrombopag.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Avatrombopag for the Treatment of Thrombocytopenia After Allogeneic Hematopoietic Stem Cell Transplant|
|Actual Study Start Date :||August 10, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Treatment (avatrombopag)
Patients receive avatrombopag PO 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.
- Incidence of adverse events of avatrombopag treatment [ Time Frame: Up to 30 days after the last dose ]Toxicities will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version (v).5 standard toxicity grading. Frequency and other descriptive statistics will be used to present the toxicity pattern.
- Failure rate of platelet recovery [ Time Frame: At day 90 ]The proportion will be provided with 95% exact binomial confidence interval.
- Independence from platelet transfusion [ Time Frame: Up to 1 year ]
- Duration of platelet response [ Time Frame: Up to 1 year ]Will be presented in a descriptive manner.
- Platelet count >= 50,000/uL for 7 consecutive days without transfusion support [ Time Frame: Up to 1 year ]
- Duration of exposure to avatrombopag [ Time Frame: Up to 1 year ]Will be presented in a descriptive manner.
- Incidence of adverse events associated with avatrombopag treatment [ Time Frame: Up to 30 days after last dose ]
- Transplant-related mortality [ Time Frame: At day 100 and 1 year post-hematopoietic stem cell transplant (HCT) ]
- Progression-free survival (PFS) of underlying malignant hematologic disorder [ Time Frame: From the time of HCT to progression and death, assessed up to 1 year ]The method of Kaplan-Meier will be used to estimate PFS.
- Overall survival (OS) [ Time Frame: From the time of HCT to death from any cause, assessed up to 1 year ]The method of Kaplan-Meier will be used to estimate OS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04312789
|Contact: Ohio State Comprehensive Cancer Center||800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Basem M. William, MD MRCP FACP 614-688-7942 basem.William@osumc.edu|
|Principal Investigator: Basem M. William, MD MRCP FACP|
|Principal Investigator:||Basem M William, MD MRCP FACP||Ohio State University Comprehensive Cancer Center|