Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-01035 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Drug availability
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sobi, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (avatrombopag) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avatrombopag | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Failure rate of platelet recovery | The proportion will be provided with 95% exact binomial confidence interval. | At day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Independence from platelet transfusion | Up to 1 year | |
| Duration of platelet response | Will be presented in a descriptive manner. | Up to 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ayman Saad, MB/BCH | Ohio State University Comprehensive Cancer Center | Principal Investigator |
Not provided
Not provided
| Label | URL |
|---|---|
| The Jamesline | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533238 | avatrombopag |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Platelet count >= 50,000/uL for 7 consecutive days without transfusion support | Up to 1 year |
| Duration of exposure to avatrombopag | Will be presented in a descriptive manner. | Up to 1 year |
| Incidence of adverse events associated with avatrombopag treatment | Up to 30 days after last dose |
| Transplant-related mortality | At day 100 and 1 year post-hematopoietic stem cell transplant (HCT) |
| 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 |
| 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 |