Chronic Myelomonocytic Leukemia Clinical Trial
Official 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
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.
The purpose of this study is to evaluate the safety and effectiveness of imatinib for
improving blood counts in patients with chronic myelomonocytic leukemia (CMML) and atypical
chronic myelogenous leukemia (CML).
Although a number of agents have been used to treat these diseases, most patients do not
respond to treatment. Imatinib has been shown in clinical trials to induce high rates of
responses in patients with chronic phase CML. Imatinib has also been shown to be effective in
inducing responses in a subset of patients with CMML and atypical CML and is also effective
in a subset of patients with idiopathic hypereosinophilic syndrome (HES), another
myeloproliferative disorder. Because patients with several different myeloproliferative
diseases have been shown to experience dramatic responses to imatinib, we would like to
determine what proportion of patients with atypical myeloproliferative diseases (CMML and
atypical CML) will respond to this agent.
Prior to enrollment, a thorough clinical evaluation will be performed. A baseline bone marrow
will be obtained to exclude acute leukemia or lymphoma and to assess the degree and nature of
the myeloproliferation. In order to minimize bone marrow suppression, other myelosuppressive
drugs will be tapered and discontinued during the first week of therapy with imatinib.
Complete blood counts will be performed weekly for the first month and every other week
thereafter. Clinical assessments will be performed every three months to assess for continued
response.
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