Avatrombopag for the Treatment of Thrombocytopenia After Donor Hematopoietic Stem Cell Transplant
NCT ID: NCT04312789
Last Updated: 2021-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2022-12-31
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Avatrombopag
Given PO
Interventions
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Avatrombopag
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sobi, Inc.
INDUSTRY
Ayman Saad
OTHER
Responsible Party
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Ayman Saad
Principal Investigator
Principal Investigators
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Ayman Saad, MB/BCH
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2020-01035
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-19328
Identifier Type: -
Identifier Source: org_study_id