Imatinib Mesylate in Treating Patients With Myelofibrosis

NCT00245128 | Terminated Phase 2 Results DMC

• 3 other identifiers: CDR0000445435OHSU-541OHSU-HEM-01071-L
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Myeloproliferative Disorders

Keywords

chronic idiopathic myelofibrosis; polycythemia vera; essential thrombocythemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy

  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.

  At 3,6, and 12 months of therapy

Secondary Outcomes (1)

• Reduction in Marrow Fibrosis and Decrease in Spleen Size

  After 6 and 12 months of therapy

Interventions

imatinib mesylate DRUG

Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Primary Myelofibrosis; Polycythemia Vera; Thrombocythemia, Essential

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

Early termination/results were never analyzed due to negative study results from other similar studies.

Results Point of Contact

• Title: Dr. Michael Mauro
• Organization: OHSU Knight Cancer Institute

maurom@ohsu.edu

503-494-1080

Study Officials

• Michael Mauro, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: August 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: October 1, 2011
• Last Updated: January 13, 2012
• Results First Posted: January 13, 2012

Record last verified: 2011-12

Locations

US (1)