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
Data Collection
Bone Marrow Diseases+12
+ Chronic Disease
+ Hematologic Diseases
Treatment Study
Summary
Study start date: January 14, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.7 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
* INCLUSION CRITERIA: All subjects must be greater than or equal to 18 years of age. All subjects must meet the established diagnostic criteria for CMML or atypical CML. The diagnostic criteria for CMML include: * persistent peripheral blood monocytosis (greater than 1000/mm(3)), * no Philadelphia chromosome or BCR/ABL fusion gene, * fewer than 20% blasts in the blood and bone marrow, and * dysplasia in one or more myeloid lineages. If dysplasia is absent the diagnosis of CMML can still be made if the other requirements are met and a cytogenetic abnormality is present in the marrow cells or if monocytosis has been persistent for at least 3 months and all other causes of monocytosis have been excluded. OR The diagnostic criteria for atypical CML include: * peripheral blood leukocytosis comprised of increased mature and immature neutrophils, * prominent dysgranulopoiesis, * no Philadelphia chromosome or BCR/ABL fusion gene, * neutrophil precursors greater than or equal to 10% of white blood cells, * basophils less than 2% of white blood cells, * monocytes less than 10% of white blood cells, * hypercellular bone marrow with granulocytic proliferation and dysplasia, and fewer than 20% blasts in the blood and bone marrow. * Serum creatinine less than 2mg/dl * ECOG performance status less than 3 * Life expectancy greater than 12 weeks * All subjects (men and women) must agree to practice abstinence or effective contraception during administration of imatinib. * Patients must be able to comprehend the investigational nature of the research and be willing to sign an informed consent. EXCLUSION CRITERIA: Pregnancy or lactation. HIV positivity or other known immunodeficiency. Absolute neutrophil count less than 1000/mm(3) or platelet count less than 10,000/mm(3) or less than 50,000/m(3) with clinical evidence of bleeding. Infection not adequately responding to appropriate therapy History of non-hematologic malignancy treated with chemotherapy in past 5 years. A moribund status or concurrent hepatic, renal, cardiac, metabolic disease of such severity that death within 12 weeks from initiation of therapy is likely. Treatment with investigational agent (other than hematopoietic growth factors) within 4 weeks of study entry. Psychiatric, affective, or other disorder that may compromise the ability to give informed consent or to cooperate in a research study. Elevated transaminases (greater than 5 times the upper limit of normal) or elevated bilirubin (greater than 3 times the upper limit of normal). Recent exposure to chickenpox or recent history of Herpes zoster (shingles) reactivation. Imatinib may put patients at increased risk of severe disease. Left ventricular ejection fraction less than 45%.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesSee the location