Protocol Number: 04-H-0090

Title:

A Pilot Study of the Safety and Efficacy of Imatinib in Reducing Monocytosis or Leukocytosis in Patients with Chronic Myelomonocytic Leukemia and Atypical Chronic Myelogenous Leukemia, Respectively

Number:

04-H-0090

Summary:

This study will evaluate the safety and effectiveness of imatinib (Gleevec® (Registered Trademark)) in patients with chronic myelomonocytic leukemia (CMML) and atypical chronic myelogenous leukemia (CML). These conditions cause uncontrolled growth of malignant (cancerous) cells in the bone marrow that prevents the bone marrow from functioning normally in producing blood cells. The cancer cells also can spill over into the blood and invade other organs of the body. Imatinib has been approved by the Food and Drug Administration for treating chronic myelogenous leukemia, which has characteristics similar to atypical CML and to CMML, and data from other research suggests this drug may be able to produce a remission in forms of leukemia other than CML.

Patients over 18 years of age with atypical CML or CMML may be eligible for this study. Candidates are screened with a medical history and physical examination, blood tests, electrocardiogram, chest x-ray, and bone marrow aspiration and biopsy (removal of a small piece of bone marrow tissue through a needle inserted into the hip bone).

Participants take imatinib capsules once a day for 2 years. If at any time during the study the patient's blood counts begin to rise, disease symptoms develop, or the disease has progressed, the dose of imatinib is increased each week until the disease progression is stopped. Any patient whose disease does not response to treatment after 6 weeks of increased dosing and 30 days at the maximum daily dose of 800 mg is taken off the study and referred for different treatment.

Patients are seen by their referring physician every week for the first 4 weeks of the study, every other week for the next 8 weeks, and then monthly until the study is completed. At each visit, blood is drawn to monitor for drug side effects and response to therapy. In addition, patients come to the NIH Clinical Center every 3 months for a complete history and physical examination and for a bone marrow aspiration and biopsy every 6 months to assess the effect of treatment on bone marrow cells.

Patients who leave the study before 2 years are followed with laboratory monitoring for 6 months after stopping imatinib; those who remain on the drug for the full 2 years are monitored for 1 year after stopping the drug.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

CMML

CML

Gleevec

Glivec

STI-571

Tyrosine Kinase Inhibitor

Chronic Myelogenous Leukemia

Atypical Chronic Myelogenous Leukemia

Chronic Myelomoncytic Leukemia

Recruitment Keyword(s):

Leukemia

Chronic Myelomoncytic Leukemia

CMML

Chronic Myelogenous Leukemia

CML

Condition(s):

Chronic Myelomonocytic Leukemia

Chronic Myelogenous Leukemia

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Drug: Imatinib

Supporting Site:

National Heart, Lung and Blood Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Germing U, Gattermann N, Minning H, Heyll A, Aul C. Problems in the classification of CMML--dysplastic versus proliferative type. Leuk Res. 1998 Oct; 22(10): 871-8.

Nosslinger T, Reisner R, Koller E, Gruner H, Tuchler H, Nowotny H, Pittermann E, Pfeilstocker M. Myelodysplastic syndromes, from French-American-British to World Health Organization: comparison of classifications on 431 unselected patients from a single institution. Blood. 2001 Nov 15; 98(10): 2935-41.

Fenaux P, Beuscart R, Lai JL, Jouet JP, Bauters F. Prognostic factors in adult chronic myelomonocytic leukemia: an analysis of 107 cases. J Clin Oncol. 1988 Sep; 6(9): 1417-24.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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