Clinical Trial: Imatinib (Gleevec(Registered Trademark)) to Treat Chronic Myelomonocytic Leukemia and Atypical Chronic Myelogenous Leukemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Myelogen
Brief 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 sid
Detailed Summary:
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.
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Current Primary Outcome: Peripheral blood absolute monocyte/leukocyte count measured at 2 months. [ Time Frame: 2-months ]
Original Primary Outcome:
Current Secondary Outcome: Resolution of bone marrow abnormalities, improvement in transfusion requirements, reduction or disappearance of cytogenetic abnormalities or fusion transcripts as detected by quantitative PCR/progression of clinical disease at 2 mths and every 3...
Original Secondary Outcome:
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: March 8, 2004
Date Started: January 14, 2004
Date Completion:
Last Updated: January 24, 2017
Last Verified: September 23, 2011
