Status:
COMPLETED
A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML)
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Myelofibrosis
Myeloid Metaplasia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 m...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00136409
Start Date
May 1 2002
End Date
December 1 2008
Last Update
December 23 2016
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115