Imatinib Mesylate in Treating Patients With Myelofibrosis

This study has been terminated.
(Per PI, results from another similar study were published prior to study analysis. Negative study results were published therefore analysis was not completed)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00245128
First received: October 25, 2005
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and how well it works in treating patients with myelofibrosis.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
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 Pilot Study to Determine the Safety and Preliminary Efficacy of Imatinib Mesylate (Gleevec) in Patients With Myelofibrosis With Myeloid Metaplasia

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy [ Time Frame: At 3,6, and 12 months of therapy ] [ Designated as safety issue: No ]

    A major response = transfusion independent or a>2.0g/dl rise in hemoglobin without transfusion maintained for at least 8 weeks.

    Minor response= > 1 to 2.0g/dl incremental rise in hemoglobin maintained for at lease 8 weeks with a decrease in transfusion requirements of at least 50% compared to the mean transfusion requirement during the 8 week pre-study period.



Secondary Outcome Measures:
  • Reduction in Marrow Fibrosis and Decrease in Spleen Size [ Time Frame: After 6 and 12 months of therapy ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2005
Study Completion Date: October 2011
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: imatinib mesylate
    Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety, efficacy, and tolerability of imatinib mesylate in patients with myelofibrosis with myeloid metaplasia.
  • Determine the 3-, 6-, and 12-month major and minor erythroid response rates in patients treated with this drug.

Secondary

  • Determine reduction in marrow fibrosis in patients treated with this drug.
  • Determine decrease in spleen size in patients treated with this drug.

OUTLINE: This is a multicenter, open-label, nonrandomized, pilot study.

Patients receive oral imatinib mesylate once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients who do not experience a minor erythroid response or a 50% reduction in spleen size after 6 months of treatment are removed from the study. Patients experiencing clinical benefit (e.g., ongoing erythroid response) after 1 year of treatment may continue treatment with imatinib mesylate as above at the discretion of the principal investigator.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of myelofibrosis with myeloid metaplasia (MMM), defined by all of the following:

    • Leukoerythroblastic blood picture
    • Fibrosis involving > 1/3 sectional area of bone marrow biopsy
    • Splenomegaly (unless patient has undergone prior splenectomy)
    • Philadelphia chromosome negative
    • No myelodysplastic syndrome
    • No systemic disorders associated with marrow fibrosis
  • Red blood cell transfusion dependent, defined by 1 of the following:

    • Patient has required ≥ 2 units of red blood cells every 4 weeks within the past 8 weeks
    • Hemoglobin ≤ 8 g/dL on ≥ 3 occasions (≥ 2 weeks apart ) over the past 8 weeks
  • No evidence of disease transformation to acute myelogenous leukemia, defined as > 20% blasts in bone marrow and/or peripheral blood

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-3

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,000/mm^3
  • Platelet count > 50,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 2 times ULN (unless due to extramedullary hematopoiesis in the liver)

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No New York Heart Association grade III-IV heart disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier method contraception during and for 3 months after completion of study treatment
  • No serious, uncontrolled medical condition
  • No patients who are considered potentially unreliable or with a history of noncompliance to medical regimens

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 2 weeks since prior interferon alfa

Chemotherapy

  • No concurrent chemotherapy except hydroxyurea to control elevated blood counts

Endocrine therapy

  • More than 4 weeks since prior corticosteroids, danazol, or other androgens for MMM

Other

  • More than 4 weeks since other prior treatment for MMM
  • No other concurrent experimental drug therapy for MMM
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245128

Locations
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Michael Mauro, MD OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00245128     History of Changes
Other Study ID Numbers: CDR0000445435, OHSU-541, OHSU-HEM-01071-L
Study First Received: October 25, 2005
Results First Received: October 25, 2011
Last Updated: December 1, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
chronic idiopathic myelofibrosis
polycythemia vera
essential thrombocythemia

Additional relevant MeSH terms:
Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014