Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients
Completed · Phase 2
Conditions studied: Leukemia, Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia
In brief
The goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the platelet count in patients with Chronic myeloid leukemia (CML) who develop low platelet counts while receiving therapy with imatinib mesylate (Gleevec, STI571), or other tyrosine kinase inhibitors such as AMN107, dasatinib, or SK1606. Primary Objective: 1\. To determine efficacy of low-dose interleukin-11, (IL-11, oprelvekin, NeumegaTM) in improving the thrombocytopenia associate with imatinib or other tyrosine kinase inhibitor therapy in patients with CML. Secondary Objective: 1\. To determine the safety of low-dose IL-11 in patients with CML and thrombocytopenia associated with imatinib or other tyrosine kinase inhibitors
Key facts
- Study ID
- NCT00493181
- Run by
- M.D. Anderson Cancer Center
- People needed
- 8
- Starts
- 2005-10-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2012-02-20
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- CML patients in chronic or accelerated phase receiving treatment with imatinib mesylate (Gleevec), or other tyrosine kinase inhibitors such as AMN107, dasatinib, or SK1606.
- Grade >/= 3 thrombocytopenia (platelets <50 * 10(9)/L) after the first 4 weeks of therapy with the tyrosine kinase inhibitor. Thrombocytopenia must be either recurrent (i.e., second or greater episode of grade >/= 3 thrombocytopenia) or having required dose reductions of the tyrosine kinase inhibitor.
- Signed informed consent.
- Expected to have therapy with imatinib continued for > 3 months.
You may not qualify if…
- Known allergies to E. coli.
- New York Heart Association (NYHA) class III or IV.
- Patient has known hypersensitivity to Neumega or any component of Neumega.
- Thrombocytopenia that is considered to be unrelated to treatment with imatinib.
- Stem cell transplantation within 60 days.
- History of atrial arrhythmias
- Pregnancy
- Papilledema
Where it is running
- UT MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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