Chronic Myeloid LeukemiaPhase 2NCT00146913
AFR10 - Combination Therapy of Imatinib Mesylate (IM) + Alpha-2A Interferon for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year
A Phase 2 study testing Imatinib mesylate 600mg/day and Peg-Interféron at 90 microg/week in people with Chronic Myeloid Leukemia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Sixty % of CML patients treated by Imatinib mesylate achieved a major cytogenetic responses (CCR) at 18 months. So, 40% of the patients must receive additional treatment. In vitro, it has been shown that IM and Interféron-alpha have synergic anti-proliferative effect on chromosome Ph+ cell lines. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Imatinib mesylate 600mg/day and Peg-Interféron at 90 microg/week
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2004to not given
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic phase Philadelphia positive CML, confirmed by karyotyping (or FISH) analysis, in complete hematologic response with IM.
- Lack of major cytogenetic response after at least one year of STI 571 as single therapy.
- Male and female * 18 years old.
- Informed consent signed up.
- Performance status grade 0 - 2 (ECOG).
- SGOT and SGPT <3N
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- Serum bilirubin < 1.5 N
- Serum creatinine < 1.5 N
- No HSC graft planned
- B-HCG negative for female with potential childbearing
Who cannot join
- Absence of complete hematologic response
- Extramedullar involvement
- Previous extra-hematologic intolerance of Interféron at a dose superior or equal to 25 MUI/week
- Depressive syndrome not controlled
- Not controlled dysthyroidy
- Auto-immune pathology not controlled
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- Women with childbearing potential who are unwilling or unable to use an adequate method to avoid pregnancy for the entire period of the study
- Significant cardiac disease (grade 3 or more)
- Known seropositivity for HIV
- Active viral hepatitis
- Other malignant disease
- Other experimental medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study Evaluating the Efficacy and Tolerance of Combination Therapy of Imatinib Mesylate (IM) +-2A Interféron for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year
Sixty % of CML patients treated by Imatinib mesylate achieved a major cytogenetic responses (CCR) at 18 months. So, 40% of the patients must receive additional treatment. In vitro, it has been shown that IM and Interféron-alpha have synergic anti-proliferative effect on chromosome Ph+ cell lines. By using Peg-Interféron and IM combination, we hope to increase the cytogenetic response of patients.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Imatinib mesylate 600mg/day, Peg-Interféron at 90 microg/week
- Keywords
- Chronic myeloid leukaemia, resistant, refractory, Imatinib mesylate
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib mesylate 600mg/dayDrug
Peg-Interféron at 90 microg/weekDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population
Secondary outcomes (1)
Evaluate the tolerance of a combination of STI571 and alpha-interferon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Mauricette MICHALLET, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146913
- Sponsor's protocol ID
- 2003.317
- Status last verified
- Apr 2007
- First submitted
- 5 Sep 2005
- Last updated
- 27 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Efficacy and Tolerance of Combination Therapy of Imatinib Mesylate (IM) +-2A Interféron for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year
- ClinicalTrials.gov ID
- NCT00146913
- Acronym / sponsor ID
- 2003.317
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Chronic myeloid leukaemia, resistant, refractory, Imatinib mesylate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2004
- First posted
- 7 Sep 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.
Sixty % of CML patients treated by Imatinib mesylate achieved a major cytogenetic responses (CCR) at 18 months. So, 40% of the patients must receive additional treatment. In vitro, it has been shown that IM and Interféron-alpha have synergic anti-proliferative effect on chromosome Ph+ cell lines. By using Peg-Interféron and IM combination, we hope to increase the cytogenetic response of patients.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Chronic phase Philadelphia positive CML, confirmed by karyotyping (or FISH) analysis, in complete hematologic response with IM.
- Lack of major cytogenetic response after at least one year of STI 571 as single therapy.
- Male and female * 18 years old.
- Informed consent signed up.
- Performance status grade 0 - 2 (ECOG).
Key exclusion criteria (12 listed)
- Absence of complete hematologic response
- Extramedullar involvement
- Previous extra-hematologic intolerance of Interféron at a dose superior or equal to 25 MUI/week
- Depressive syndrome not controlled
- Not controlled dysthyroidy
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 mesylate 600mg/day | Drug | – |
| Peg-Interféron at 90 microg/week | Drug | – |
Primary outcome
Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population
1 secondary outcome
Evaluate the tolerance of a combination of STI571 and alpha-interferon
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
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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.
Mauricette MICHALLET, MD principal investigator
Hospices Civils de Lyon
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 600mg/day and Peg-Interféron at 90 microg/week in people with Chronic Myeloid Leukemia, run by Hospices Civils de Lyon at 1 site in France.
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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 27 Apr 2007. 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 France. 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?
Results are not available in the source record.
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?
Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population. 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 27 Apr 2007.