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

NCT00493181

Last updated date
Study Location
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Leukemia, Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Leukemia, Chronic Myelogenous Leukemia, Chronic Myeloid LeukemiaInterleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients
NCT00493181
  1. Houston, Texas
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients
Official Title  ICMJE The Effect of Interleukin 11 on Thrombocytopenia Associated With Imatinib or Other Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myelogenous Leukemia
Brief 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia
  • Chronic Myelogenous Leukemia
  • Chronic Myeloid Leukemia
Intervention  ICMJE Drug: Interleukin-11 (IL-11 or Neumega)
10 mcg/kg under the skin (usually of the arms, legs or abdomen) three times weekly. If the treatment is well tolerated but there is not enough of a platelet improvement, the dose and frequency of injections may be increased.
Other Names:
  • IL-11
  • Neumega
Study Arms  ICMJE Experimental: Interleukin-11
Starting dose 10 mcg/kg subcutaneously 3 times a week
Intervention: Drug: Interleukin-11 (IL-11 or Neumega)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2011)
8
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2007)
30
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00493181
Other Study ID Numbers  ICMJE 2004-0113
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Jorge E. Cortes, MDM.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP