a study of gleevec in patients with idiopathic myelofibrosis or chronic myelomonocytic leukemia (cmml)

Conditions: Myelofibrosis; Myeloid Metaplasia; Agnogenic Myeloid Metaplasia; Chronic Myelomonocytic Leukemia

Summary: the purpose of this study is to determine the effects (good and bad) of gleevec in patients with bcr-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia and chronic myelomonocytic leukemia.

gleevec will be administered at a dose of 400 mg orally once daily. patients will continue to receive the drug until either drug progression or the development of intolerable side effects. patients will be assessed with a complete blood count weekly for the first 8 weeks and will have monthly physical examinations and bone marrow examinations every 3 months.

Eligibility criteria:
inclusion criteria: * patients must have a clinical diagnosis of myelofibrosis with myeloid metaplasia or chronic myelomonocytic leukemia (cmml). patients may be entered based on a prior cytogenetic karyotype showing the absence of the philadelphia chromosome. * patients may be entered prior to completion of reverse transcription-polymerase chain reaction (rt-pcr) or fluorescent in situ hybridization (fish) studies, but a patient who is subsequently found to be bcr-abl or fish positive will be removed from protocol treatment. fish will only be performed on patients with a normal karyotype. a pcr sample will be sent on all patients. * the patients with myelodysplasia must have french-american-british (fab) subtype chronic myelomonocytic leukemia (cmml) defined as peripheral blood monocytosis, and less than 30 percent blasts in the peripheral blood or the bone marrow. * the patients with myelofibrosis with myeloid metaplasia can have one of the following: agnogenic myeloid metaplasia (idiopathic myelofibrosis), or post-polycythemic myeloid metaplasia (post-polycythemic myelofibrosis), or post-thrombocythemic myeloid metaplasia. * estimated life expectancy of 6 months or greater. * serum bilirubin equal to or less than twice the upper limit of normal. * serum sgot and sgpt equal to or less than twice the upper limit of normal. * serum creatinine equal to or less than twice the upper limit of normal. * age at least 18 years. * greater than 4 weeks from any chemotherapy (except hydroxyurea), radiotherapy, immunotherapy, or systemic glucocorticoid therapy (non-glucocorticoid hormonal therapy is allowed). systemic glucocorticoid therapy for non-malignant disease is allowed. * the last dose of hydroxyurea must be 24 hours prior to the initiation of gleevec. * greater than 2 months following bone marrow or peripheral blood stem cell transplantation or treatment with donor lymphocyte infusion (dli). exclusion criteria: * uncontrolled active infection. * pregnancy or nursing mothers. * patients with myelofibrosis with myeloid metaplasia or chronic myelomonocytic leukemia who have transformed to acute myelogenous leukemia. * prior treatment or diagnosis of acute myelogenous leukemia. * patients with philadelphia positive cytogenetics by either peripheral blood or bone marrow sampling. * eastern cooperative oncology group (ecog) performance status \> 3. * prior exposure to gleevec. * active central nervous system (cns) disease. * evidence of infection with the human immunodeficiency virus. * active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely.

Keywords: myelofibrosis agnogenic myeloid metaplasia with myelofibrosis cmml chronic myelomonocytic leukemia imatinib mesylate gleevec