Overview

Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Imatinib Mesylate
Oprelvekin
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 <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.

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