A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML)
NCT ID: NCT00136409
Last Updated: 2016-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2002-05-31
2008-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mono-Therapy Gleevec
Gleevec administered orally at a pre-determined dose once daily.
Imatinib mesylate
400mg orally once daily until disease progression or unacceptable side effects
Interventions
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Imatinib mesylate
400mg orally once daily until disease progression or unacceptable side effects
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Brigham and Women's Hospital
OTHER
Massachusetts General Hospital
OTHER
Novartis
INDUSTRY
Responsible Party
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Daniel J. DeAngelo, MD, PhD
Principal Investigator
Principal Investigators
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Daniel J. DeAngelo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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01-214
Identifier Type: -
Identifier Source: org_study_id