Chronic Myeloproliferative DisordersPhase 2NCT00245128
Imatinib Mesylate in Treating Patients With Myelofibrosis
A Phase 2 study testing imatinib mesylate in people with Chronic Myeloproliferative Disorders, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloproliferative Disorders
- What is being tested?
- imatinib mesylate
- Type of treatment
- Pill or oral medicine
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Oct 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239-3098
About this study
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
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.
Read the 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.
- Conditions
- Chronic Myeloproliferative Disorders
- Being tested
- imatinib mesylate
- Keywords
- chronic idiopathic myelofibrosis, polycythemia vera, essential thrombocythemia
- Medical subject headings
- Myeloproliferative Disorders, Primary Myelofibrosis, Polycythemia Vera, Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib mesylateDrug
Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3,6, and 12 months of therapy
Secondary outcomes (1)
Reduction in Marrow Fibrosis and Decrease in Spleen Size
Measured: After 6 and 12 months of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startAug 2005
- Primary completionMar 2007
- Study completionOct 2011
Why it stopped: Per PI, results from another similar study were published prior to study analysis. Negative study results were published therefore analysis was not completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Mauro, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245128
- Sponsor's protocol ID
- CDR0000445435
- Other IDs
- OHSU-541, OHSU-HEM-01071-L
- Status last verified
- Dec 2011
- First submitted
- 25 Oct 2005
- Last updated
- 13 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00245128
- Acronym / sponsor ID
- CDR0000445435
- Conditions
- Chronic Myeloproliferative Disorders
- Keywords
- chronic idiopathic myelofibrosis, polycythemia vera, essential thrombocythemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per PI, results from another similar study were published prior to study analysis. Negative study results were published therefore analysis was not completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 27 Oct 2005 (estimated)
- Results
- Posted 13 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imatinib mesylateOnce daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months. | Drug | – |
Primary outcome
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
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.
1 secondary outcome
Reduction in Marrow Fibrosis and Decrease in Spleen Size
Time frame: After 6 and 12 months of therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Mauro, MD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing imatinib mesylate in people with Chronic Myeloproliferative Disorders, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2012.