A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML)
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ClinicalTrials.gov Identifier: NCT00136409 |
Recruitment Status :
Completed
First Posted : August 29, 2005
Last Update Posted : December 23, 2016
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Condition or disease | Intervention/treatment | Phase |
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Myelofibrosis Myeloid Metaplasia Agnogenic Myeloid Metaplasia Chronic Myelomonocytic Leukemia | Drug: Imatinib mesylate | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Gleevec (Imatinib Mesylate) In Patients With BCR-Negative Myeloproliferative Disorders Including Patients With Idiopathic Myelofibrosis With Myeloid Dysplasia or Chronic Myelomonocytic Leukemia |
Study Start Date : | May 2002 |
Actual Primary Completion Date : | August 2005 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Mono-Therapy Gleevec
Gleevec administered orally at a pre-determined dose once daily.
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Drug: Imatinib mesylate
400mg orally once daily until disease progression or unacceptable side effects
Other Name: Gleevec |
- To determine the overall response rate of Gleevec as a single agent in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia and chronic myelomonocytic leukemia [ Time Frame: 3 years ]
- To determine the safety and efficacy of Gleevec as a single agent in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia or chronic myelomonocytic leukemia [ Time Frame: 3 years ]
- to determine the biologic activity of Gleevec in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia or chronic myelomonocytic leukemia [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136409
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Daniel J. DeAngelo, MD, PhD | Dana-Farber Cancer Institute |
Responsible Party: | Daniel J. DeAngelo, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00136409 |
Other Study ID Numbers: |
01-214 |
First Posted: | August 29, 2005 Key Record Dates |
Last Update Posted: | December 23, 2016 |
Last Verified: | December 2016 |
myelofibrosis agnogenic myeloid metaplasia with myelofibrosis CMML |
chronic myelomonocytic leukemia imatinib mesylate Gleevec |
Leukemia Leukemia, Myelomonocytic, Acute Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Primary Myelofibrosis Metaplasia Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases |
Hematologic Diseases Leukemia, Myeloid Myelodysplastic-Myeloproliferative Diseases Pathologic Processes Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |