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The Effect of Interleukin 11 on Thrombocytopenia Associated With Imatinib or Other Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myelogenous Leukemia

Phase 2
Not Enrolling
Leukemia, Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia

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Trial Information

The Effect of Interleukin 11 on Thrombocytopenia Associated With Imatinib or Other Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myelogenous Leukemia

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

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

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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Complete Response

Outcome Description:

Number of participants with platelet response of 'Complete Response' (CR) defined as a sustained (>/= 3 months) platelet count >/= 60 x 10^9/L while continuing tyrosine kinase inhibitor (TKI) therapy or sustained (>/= 3 months) re-escalation of TKI dose to the pre-thrombocytopenia level without recurrence of thrombocytopenia.

Outcome Time Frame:

Weekly platelet count till stabilized with on-going review while receiving treatment (study total 2 years)

Safety Issue:


Principal Investigator

Jorge E. Cortes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

January 2011

Related Keywords:

  • Leukemia
  • Chronic Myelogenous Leukemia
  • Chronic Myeloid Leukemia
  • oprelvekin
  • tyrosine kinase inhibitor
  • Chronic Myelogenous Leukemia
  • Leukemia
  • CML
  • Thrombocytopenia
  • Imatinib
  • IL-11
  • Interleukin 11
  • Neumega
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Thrombocytopenia



UT MD Anderson Cancer CenterHouston, Texas  77030