Eltrombopag for the Management of Thrombocytopenia Associated With Tyrosine Kinase Therapy in Patients With Chronic Myeloid Leukemia (CML)
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive eltrombopag by
mouth 1 time a day. Your dose may be increased every 2 weeks depending on your platelet
count response.
You should take eltrombopag on an empty stomach. You should not eat for 2 hours before
taking eltrombopag. You should wait at least 4 hours between taking eltrombopag and taking
other drugs (like antacids), dairy products, juices with calcium added, or supplements
containing iron, calcium, aluminum, magnesium, selenium, or zinc.
Study Visits:
Some of the routine blood draws listed below may be done at a clinic near your home. Ask
the study staff for more details about this.
The dose adjustment phase is when the study doctor will change the dose of the study drug or
your drug for treatment of CML or myelofibrosis.
During the dose adjustment phase:
- Before the most effective dose is found, blood (about 1-2 tablespoons) will be drawn 1
time every week for routine tests and to check your platelet counts.
- After the most effective dose is found, blood (about 1-2 tablespoons) will be drawn 1
time each month for routine tests and to check your platelet counts.
During the first year of eltrombopag therapy, every 3-4 months:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your height, weight, and vital
signs.
- You will be asked about side effects you may be having and any other drugs you may be
taking.
- You will have a standard-of-care bone marrow aspiration and/or biopsy to check the
status of the disease. This sample will also be used for genetic research tests. If
an aspirate cannot be collected, blood (about 1 teaspoon) will be drawn for these
tests.
After the first year of eltrombopag therapy, every 6 months, you will return to the clinic
and have the same tests and procedures performed as listed above.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment
visit.
End-of-Treatment Visit:
About 30 days after your last dose of study drug, you will return to the clinic for an
end-of-treatment visit.
- You will have a physical exam, including measurement of your height, weight, and vital
signs.
- You will be asked about any side effects you may be having.
- Blood (about 1-2 tablespoons) will be drawn for routine tests. This blood will also be
used to check your platelet counts.
This is an investigational study. Eltrombopag is FDA approved and commercially available
for the treatment of patients with low platelet counts. The use of eltrombopag for the
treatment of low platelet counts in patients with CML and myelofibrosis is investigational.
Up to 39 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Complete Platelet Response
Complete (platelet) response defined as a sustained (3 months) platelet count of ≥ 50 x 109/L and at least a 20% increase in platelet count from baseline with no more than 3 counts in that period being ≤ 50 * 109/L , while continuing imatinib or other TKI therapy. Complete Blood Counts (CBCs), including platelet count, weekly at beginning of treatment or with dose adjustments until stable platelet count achieved, monthly thereafter.
Every 3 to 4 months (Baseline to 3 months confirmed Complete Platelet Response, up to 18 months following treatment initiation.)
Yes
Gautam Borthakur, MBBS
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2011-0319
NCT01428635
January 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |