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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

Tracking Information
First Submitted Date  ICMJE August 25, 2005
First Posted Date  ICMJE August 29, 2005
Last Update Posted Date December 23, 2016
Study Start Date  ICMJE May 2002
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
  • 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
  • to determine the biologic activity of Gleevec in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia or chronic myelomonocytic leukemia.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML)
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myelofibrosis
  • Myeloid Metaplasia
  • Agnogenic Myeloid Metaplasia
  • Chronic Myelomonocytic Leukemia
Intervention  ICMJE Drug: Imatinib mesylate
400mg orally once daily until disease progression or unacceptable side effects
Other Name: Gleevec
Study Arms  ICMJE Experimental: Mono-Therapy Gleevec
Gleevec administered orally at a pre-determined dose once daily.
Intervention: Drug: Imatinib mesylate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2016)
34
Original Enrollment  ICMJE
 (submitted: August 25, 2005)
60
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00136409
Other Study ID Numbers  ICMJE 01-214
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Novartis
Investigators  ICMJE
Principal Investigator: Daniel J. DeAngelo, MD, PhD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP