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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Peripheral blood absolute monocyte/leukocyte count measured at 2 months.
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|