Imatinib Mesylate in Treating Patients With Myelofibrosis
A Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known as STI-571) In Patients With Myelofibrosis
6 other identifiers
interventional
18
1 country
1
Brief Summary
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have myelofibrosis. Imatinib mesylate may stop the growth of myelofibrosis by blocking certain enzymes necessary for cell growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 6, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedFebruary 25, 2014
December 1, 2012
5.3 years
June 6, 2002
February 24, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Clinical responses in terms of improvement in anemia and splenomegaly as previously published for myelofibrosis
Up to 12 months
Frequency of adverse events graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Exact 95% confidence intervals generated using the binomial distribution.
Up to 12 months
Secondary Outcomes (2)
Progression-free survival
Up to 12 months
Bone marrow response
Up to 12 months
Study Arms (1)
Treatment (imatinib mesylate)
EXPERIMENTALPatients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.
Interventions
Given orally
Eligibility Criteria
You may qualify if:
- Patients must have histologic confirmation of one of the following diseases-
- Myeloid metaplasia with myelofibrosis (this includes all subtypes- chronic idiopathic myelofibrosis or agnogenic myeloid metaplasia, post thrombocythemic and post polycythemic myelofibrosis) or
- Chronic myelomonocytic leukemia (CMMOL) with t(5;12)(q31-33;p12) or TEL-PDGFRβ rearrangement; patients with CMMOL and the t(5;7)(q31-33;q11.2) or other chromosomal translocations resulting in activation of PDGFR will also be eligible
- Patients must have anemia (hemoglobin \< 11 g/dL) or palpable splenomegaly (measured in cm from costal margin- to eligible); patients with palpable splenomegaly must have spleen size documented ultrasonographically as well; they must also meet standard diagnostic criteria for MMM\* or CMMOL; patients with MMM must have thrombocytopenia (platelet count \< 100 x 10\^9/L) to be eligible; they must be Philadelphia chromosome or (BCR/ABL) rearrangement negative
- Patients with CMMOL must also have the t(5;12)(q31-33;p12) or TEL-PDGFRβ rearrangement to be eligible
- The Italian diagnostic criteria for MMM
- Necessary criteria
- Diffuse bone marrow fibrosis
- Absence of the Philadelphia chromosome or BCR-ABL rearrangement in peripheral blood cells
- Optional criteria
- Splenomegaly of any grade
- Anisopoikilocytosis with tear drop erythrocytes
- Presence of circulating immature myeloid cells
- Presence of circulating erythroblasts
- Presence of clusters of megakaryoblasts and anomalous megakaryocytes in bone marrow sections
- +19 more criteria
You may not qualify if:
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to STI-571
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because STI-571 is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with STI-571, STI-571 should not be administered patients who are breastfeeding
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with STI-571; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
- Because warfarin is metabolized through the CYP450 system, and since gastrointestinal bleeding may occur with STI-571, no therapeutic anticoagulation with warfarin will be permitted in patients participating in this study; as an alternative, therapeutic anticoagulation may be accomplished using low-molecular weight heparin (e.g. Lovenox) or heparin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olatoyosi Odenike
University of Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2002
First Posted
January 27, 2003
Study Start
April 1, 2002
Primary Completion
August 1, 2007
Last Updated
February 25, 2014
Record last verified: 2012-12