Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia; Chronic Myelogenous Leukemia; Chronic Myeloid Leukemia
Intervention: Interleukin-11 (IL-11 or Neumega) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): Jorge E. Cortes, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center
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
Clinical Details
Official title: The Effect of Interleukin 11 on Thrombocytopenia Associated With Imatinib or Other Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myelogenous Leukemia
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants With Complete Response
Detailed description:
IL-11 is a hormone normally produced in your body that plays a role in stimulating the
production of platelets.
Before you can start treatment on this study, you will have what are called "screening
tests". These tests will help the doctor decide if you are eligible to take part in the
study. You will have a blood sample (1 teaspoon) collected to check your platelet count.
Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will receive one injection
of IL-11 under the skin (usually of the arms, legs or abdomen) 3 times a week. If your
platelet count increases, treatment will continue on this schedule as long as a platelet
increase is observed. If the treatment is well tolerated but there is not enough of a
platelet improvement, the dose and frequency of IL-11 injections may be increased. If the
platelet count becomes high enough, treatment may be stopped but may also be restarted if
necessary.
During therapy with IL-11, additional blood samples (1 teaspoon each) will be collected to
measure the platelet count every week until the platelets are stable and then every 2 to 6
weeks while you are receiving treatment on study. No other tests are required for this
study.
While you are on this study, you will continue your treatment with imatinib mesylate or
other tyrosine kinase inhibitor as decided by your doctor for standard care. You will be
taken off if there is no response to treatment or if there are unacceptable side effects.
There will be no follow-up after you go off study.
This is an investigational study. The Food and Drug Administration (FDA) has approved IL-11
for use in chemotherapy-caused low platelet counts. A maximum of 30 patients will take part
in this study. All will be enrolled at M. D. Anderson.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
UT MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
M.D. Anderson's Website
Starting date: October 2005
Last updated: February 17, 2012
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