MyelofibrosisPhase 2NCT00136409
A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML)
A Phase 2 study testing Imatinib mesylate in people with Myelofibrosis and Myeloid Metaplasia, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Myeloid Metaplasia, Agnogenic Myeloid Metaplasia
- What is being tested?
- Imatinib mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2002to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Myelofibrosis, Myeloid Metaplasia, Agnogenic Myeloid Metaplasia, Chronic Myelomonocytic Leukemia
- Being tested
- Imatinib mesylate
- Keywords
- myelofibrosis, agnogenic myeloid metaplasia with myelofibrosis, CMML, chronic myelomonocytic leukemia, imatinib mesylate, Gleevec
- Medical subject headings
- Primary Myelofibrosis, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib mesylateDrug
Also called Gleevec
400mg orally once daily until disease progression or unacceptable side effects
| Study group | Role | What they receive |
|---|---|---|
| Mono-Therapy Gleevec | Experimental | Gleevec administered orally at a pre-determined dose once daily. Receives: Drug: Imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (2)
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
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startMay 2002
- Primary completionAug 2005
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Dana-Farber 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, Novartis
- Responsible party
- Principal investigator, Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Daniel J. DeAngelo, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136409
- Sponsor's protocol ID
- 01-214
- Status last verified
- Dec 2016
- First submitted
- 25 Aug 2005
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00136409
- Acronym / sponsor ID
- 01-214
- Conditions
- Myelofibrosis, Myeloid Metaplasia, Agnogenic Myeloid Metaplasia, Chronic Myelomonocytic Leukemia
- Keywords
- myelofibrosis, agnogenic myeloid metaplasia with myelofibrosis, CMML, chronic myelomonocytic leukemia, imatinib mesylate, Gleevec
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, Novartis
- Study start
- May 2002
- Primary completion
- Aug 2005 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mono-Therapy Gleevec | Experimental | Drug: Imatinib mesylateGleevec administered orally at a pre-determined dose once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 mesylateAlso: Gleevec400mg orally once daily until disease progression or unacceptable side effects | Drug | Mono-Therapy Gleevec |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
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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.
Daniel J. DeAngelo, MD, PhD principal investigator
Dana-Farber Cancer Institute
2 sites 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 Myelofibrosis and Myeloid Metaplasia, run by Dana-Farber Cancer Institute at 2 sites 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?
The sponsor lists 12 inclusion and 10 exclusion criteria. 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: finished, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 23 Dec 2016.