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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-02348 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2012-0920 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well eltrombopag olamine works in increasing platelet counts in patients undergoing transplant. Eltrombopag olamine may help platelet counts and the immune system recover from blood or bone marrow transplant.
PRIMARY OBJECTIVES:
I. To estimate the rate of platelet engraftment by day 60 in patients undergoing cord blood transplant (CBT) or haploidentical donor stem cell transplantation treated with eltrombopag (eltrombopag olamine).
SECONDARY OBJECTIVES:
I. To assess safety of eltrombopag in this population. II. To assess neutrophil engraftment with eltrombopag in this population. III. To characterize immune reconstitution. IV. To assess overall survival (OS). V. To assess progression free survival (PFS). VI. To assess incidence of acute graft-versus-host disease (GVHD).
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (CORD BLOOD TRANSPLANT): Patients receive eltrombopag olamine orally (PO) once daily (QD) for 60 days beginning on day -1.
ARM II (HAPLOIDENTICAL DONOR STEM CELL TRANSPLANT): Patients receive eltrombopag olamine PO QD for 60 days beginning on day 5.
After completion of study treatment, patients are followed up at 1, 2, 3, 6, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (cord blood transplant patients) | Experimental | Patients receive eltrombopag olamine PO QD for 60 days beginning on day -1. |
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| Arm II (haploidentical donor stem cell transplant patients) | Experimental | Patients receive eltrombopag olamine PO QD for 60 days beginning on day 5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag Olamine | Drug | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Achieved Platelet Engraftment Greater Than 50K/ul | Number of participants that achieved platelet engraftment greater than 50K/ul 60 days post transplant. | Up to day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Number of participants that survived at one year post transplant. | Up to 1 year |
| Progression Free Survival | Number of participants without disease progression at 1 year post transplant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uday Popat | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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October 2013 to November 2016. All participants were registered in University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Cord Blood Transplant Patients) | Patients receive eltrombopag olamine PO QD for 60 days beginning on day -1. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies |
| FG001 | Arm II (Haploidentical Donor Stem Cell Transplant Patients) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 24, 2020 |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Up to 1 year |
Patients receive eltrombopag olamine PO QD for 60 days beginning on day 5. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Cord Blood Transplant Patients) | Patients receive eltrombopag olamine PO QD for 60 days beginning on day -1. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies |
| BG001 | Arm II (Haploidentical Donor Stem Cell Transplant Patients) | Patients receive eltrombopag olamine PO QD for 60 days beginning on day 5. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Achieved Platelet Engraftment Greater Than 50K/ul | Number of participants that achieved platelet engraftment greater than 50K/ul 60 days post transplant. | Posted | Count of Participants | Participants | Up to day 60 |
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| Secondary | Overall Survival | Number of participants that survived at one year post transplant. | Posted | Count of Participants | Participants | Up to 1 year |
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| Secondary | Progression Free Survival | Number of participants without disease progression at 1 year post transplant. | Posted | Count of Participants | Participants | Up to 1 year |
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Up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Cord Blood Transplant Patients) | Patients receive eltrombopag olamine PO QD for 60 days beginning on day -1. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies | 0 | 6 | 2 | 6 | 2 | 6 |
| EG001 | Arm II (Haploidentical Donor Stem Cell Transplant Patients) | Patients receive eltrombopag olamine PO QD for 60 days beginning on day 5. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies | 3 | 42 | 2 | 42 | 8 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Infections and infestations | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Bronchial infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Catheter related infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Infections and infestations | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Lethargy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Pleural infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Soft tissue infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Uday Popat, M.D. / Stem Cell Transplantation | The University of Texas MD Anderson Cancer Center | 713-792-8750 | upopat@mdanderson.org |
| Jun 28, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C520809 | eltrombopag |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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