Eltrombopag Olamine in Treating Thrombocytopenia in Patients With Chronic Myeloid Leukemia or Myelofibrosis Receiving Tyrosine Kinase Therapy
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|ClinicalTrials.gov Identifier: NCT01428635|
Recruitment Status : Active, not recruiting
First Posted : September 5, 2011
Last Update Posted : January 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Primary Myelofibrosis Thrombocytopenia||Drug: Eltrombopag Olamine||Phase 2 Phase 3|
I. To determine the efficacy of eltrombopag (eltrombopag olamine) for patients with chronic myeloid leukemia (CML) or myelofibrosis (MF) who have developed thrombocytopenia during the course of therapy with tyrosine kinase inhibitors (TKI) as measured by recovery of platelet count.
I. To determine the safety of eltrombopag for patients with CML or MF who have developed thrombocytopenia during the course of therapy with TKI.
II. To determine the dose intensity of TKI after start of therapy with eltrombopag.
III. To determine response to TKI after start of therapy with eltrombopag.
Patients receive eltrombopag olamine orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Eltrombopag for the Management of Thrombocytopenia Associated With Tyrosine Kinase Therapy in Patients With Chronic Myeloid Leukemia (CML) and Myelofibrosis (MF)|
|Actual Study Start Date :||January 13, 2012|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||January 31, 2022|
Experimental: Supportive care (eltrombopag olamine)
Patients receive eltrombopag olamine PO QD in the absence of disease progression or unacceptable toxicity.
Drug: Eltrombopag Olamine
- Efficacy of eltrombopag olamine to increase platelet count as indicated by at least 30% of subjects having a complete (platelet) response: proportions of subjects with complete (platelet) response [ Time Frame: Up to 30 days after the last dose of study drug ]The proportions of subjects with complete (platelet) response will be reported together with exact 95% confidence intervals. The denominator will include all subjects who received eltrombopag olamine. Platelet counts over time and in relationship to exposure to eltrombopag and tyrosine kinase inhibitor (TKI) will be summarized using descriptive statistics.
- Risk of leukemia defined as suboptimal response and progression to accelerated or blastic phase over time [ Time Frame: Up to 30 days after the last dose of study drug ]Kaplan-Meier methods will be used.
- Determining the extent of exposure to eltrombopag olamine [ Time Frame: Up to 30 days after the last dose of study drug ]Summarized using descriptive statistics. Number of days needed for response and number of days on Eltrombopag
- Number of subjects with adverse events, serious adverse events, and adverse events leading to discontinuation, scored using Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days after the last dose of study drug ]Adverse events will be reported by type, severity and frequency.
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): NCT01428635
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gautam Borthakur||M.D. Anderson Cancer Center|