Phase 2
Completed N=8
Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients
Source: ClinicalTrials.gov NCT00493181 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Number of Participants With Complete Response — 3 Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Response |
3 | — |
Eligibility Criteria
Inclusion Criteria
- 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 /= 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00493181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.