Study title
Eltrombopag for low platelet count associated with TKI in CML [USA]
Scientific title
Eltrombopag for the management of thrombocytopenia associated with tyrosine kinase therapy in patients with chronic myeloid leukemia (CML) and myelofibrosis (MF) (ClinicalTrials.gov NCT01428635)
Indication and most important inclusion criteria
This study includes patients 18 years and older diagnosed with CML in chronic phase. Patients must have been receiving an FDA-approved tyrosine kinase inhibitor (TKI) for at least 3 months.
Patients must have a decrease of platelets in the blood (known as "thrombocytopenia"), grade 3, that is recurrent (at least two episodes) or requiring dose reductions of the tyrosine kinase inhibitor.
Short description of intervention
Patients with CML receiving tyrosine kinase inhibitors who develop persistent or profound decrease of platelets ("thrombocytopenia") are offered eltrombopag together with continuation of their TKI. The goal of this study is to learn if eltrombopag can improve the platelet count in the blood.
Type of study
Other studies
In a single country
Current status
No longer recruiting patients
Study sponsor
MD Anderson Cancer Center
Scientific lead / contact
Jorge Cortes
Principal investigator
Gautam Borthakur
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
United States
MD Anderson Cancer Center
University of Texas
Houston, Texas
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Inclusion criteria
Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.
Chronic phase
The earliest phase of CML development.
Indication
In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.
Platelets
Platelets are small cell fragments that circulate in the blood and help the clotting process. Platelets prevent bleeding and are therefore indispensable.
Also called thrombocytes
Cytopenia
The condition of having a deficient number of one or more elements in the blood. Depending on which types of blood cells are decreased, the condition is also called leuko(cyto)penia, granulopenia, lympho(cyto)penia, mono(cyto)penia, erythro(cyto)penia or thrombo(cyto)penia.
Chronic
Long-lasting, slowly developping
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
FDA
An agency of the United States Department of Health and Human services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food and drugs.
