A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML)

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Novartis
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00136409
First received: August 25, 2005
Last updated: March 9, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Myelofibrosis
Myeloid Metaplasia
Agnogenic Myeloid Metaplasia
Chronic Myelomonocytic Leukemia
Drug: Imatinib mesylate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2002
Study Completion Date: December 2008
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Imatinib mesylate
    400mg orally once daily until disease progression or unacceptable side effects
    Other Name: Gleevec
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Daniel DeAngelo, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00136409     History of Changes
Other Study ID Numbers: 01-214
Study First Received: August 25, 2005
Last Updated: March 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
myelofibrosis
agnogenic myeloid metaplasia with myelofibrosis
CMML
chronic myelomonocytic leukemia
imatinib mesylate
Gleevec

Additional relevant MeSH terms:
Primary Myelofibrosis
Leukemia
Leukemia, Myelomonocytic, Chronic
Metaplasia
Leukemia, Myelomonocytic, Acute
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Pathologic Processes
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014