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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04312789
Other study ID # OSU-19328
Secondary ID NCI-2020-01035
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date December 2022
Est. completion date December 31, 2022

Study information

Verified date November 2021
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Avatrombopag
Given PO

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Ayman Saad Dova Pharmaceuticals

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events of avatrombopag treatment 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. Up to 30 days after the last dose
Primary Failure rate of platelet recovery The proportion will be provided with 95% exact binomial confidence interval. At day 90
Secondary Independence from platelet transfusion Up to 1 year
Secondary Duration of platelet response Will be presented in a descriptive manner. Up to 1 year
Secondary Platelet count >= 50,000/uL for 7 consecutive days without transfusion support Up to 1 year
Secondary Duration of exposure to avatrombopag Will be presented in a descriptive manner. Up to 1 year
Secondary Incidence of adverse events associated with avatrombopag treatment Up to 30 days after last dose
Secondary Transplant-related mortality At day 100 and 1 year post-hematopoietic stem cell transplant (HCT)
Secondary Progression-free survival (PFS) of underlying malignant hematologic disorder The method of Kaplan-Meier will be used to estimate PFS. From the time of HCT to progression and death, assessed up to 1 year
Secondary Overall survival (OS) The method of Kaplan-Meier will be used to estimate OS. From the time of HCT to death from any cause, assessed up to 1 year
See also
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Completed NCT02979158 - Preoperative Dual Antiplatelet Therapy: Platelet Function and Influence of Cardiopulmonary Bypass N/A
Recruiting NCT04842760 - PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer
Completed NCT01880047 - Safety and Efficacy of Eltrombopag at Escalated Doses Phase 2
Recruiting NCT05143892 - Avatrombopag to Promote Platelet Engraftment After Allo-HSCT Phase 2

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