Interleukin 11, Thrombocytopenia, CML, Imatinib in CML Patients - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Wyeth
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00493181

Purpose

Primary 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

1. To determine the safety of low-dose IL-11 in patients with CML and thrombocytopenia associated with imatinib or other tyrosine kinase inhibitors

Condition	Intervention	Phase
Leukemia Chronic Myelogenous Leukemia CML	Drug: IL-11 (Neumega)	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Imatinib Imatinib mesylate Tyrosine Oprelvekin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Effect of Interleukin 11 on Thrombocytopenia Associated With Imatinib or Other Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myelogenous Leukemia

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	30
Study Start Date:	October 2005

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 FDA has approved IL-11 for use in chemotherapy-caused low platelet counts. IL-11 will be provided free of charge during your participation in this study. A maximum of 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

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 x 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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493181

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Wyeth

Investigators

Principal Investigator:

Jorge E. Cortes, MD

U.T.M.D. Anderson Cancer Center

More Information

M.D. Anderson's Website This link exits the ClinicalTrials.gov site

Study ID Numbers:	2004-0113
Study First Received:	June 26, 2007
Last Updated:	September 25, 2007
ClinicalTrials.gov Identifier:	NCT00493181
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Chronic Myelogenous Leukemia
Leukemia
CML
Thrombocytopenia

Imatinib
IL-11
Interleukin 11
Neumega

Study placed in the following topic categories:

Imatinib
Thrombocytopathy
Leukemia
Oprelvekin
Thrombocytopenia
Chronic myelogenous leukemia

Hematologic Diseases
Blood Platelet Disorders
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009