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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
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Novartis
Information provided by (Responsible Party):
Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute

Study Description
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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 myelomonocytic leukemia.

Condition or disease Intervention/treatment Phase
Myelofibrosis Myeloid Metaplasia Agnogenic Myeloid Metaplasia Chronic Myelomonocytic Leukemia Drug: Imatinib mesylate Phase 2

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mono-Therapy Gleevec
Gleevec administered orally at a pre-determined dose once daily.
 Drug: Imatinib mesylate
400mg orally once daily until disease progression or unacceptable side effects
Other Name: Gleevec


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Novartis
Investigators
Principal Investigator: Daniel J. DeAngelo, MD, PhD Dana-Farber Cancer Institute
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Daniel J. DeAngelo, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00136409     History of Changes
Other Study ID Numbers: 01-214
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016

Keywords provided by Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute:
myelofibrosis
agnogenic myeloid metaplasia with myelofibrosis
CMML
 chronic myelomonocytic leukemia
imatinib mesylate
Gleevec

Additional relevant MeSH terms:
Leukemia
Primary Myelofibrosis
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myeloproliferative Disorders
Metaplasia
Neoplasms by Histologic Type
Neoplasms
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