Chronic Myeloid LeukemiaPhase 2NCT00219752
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years
A Phase 2 study testing Imatinib mesylate 400 mg in people with Chronic Myeloid Leukemia, run by Poitiers University Hospital at 1 site in France.
Trial summary
The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis of cml is being performed within 1 year. Quality of life will be carefully assessed. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Imatinib mesylate 400 mg
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2002to May 2007
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- CML Ph+ (assessed by cytogenetic or FISH)
- Chronic phase with less than 5% bone marrow blasts
- Diagnosis within 12 months
- Age ≥ 70 year at inclusion
- PS grade 0 to 2 (ECOG)
- Mini mental status more than 25
- Hydroxyurea optional before Imatinib
- Adequate end organ function, defined as the following: total bilirubin <1.5x uln, sgpt <3x uln, creatinine <1.5x uln.
Who cannot join
- patients who cannot sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
- Mini mental status ≤ 25
- patients who are not able to adequately take the study drug
- Age less than 70 y
- accelerated or blastic phase
- previous therapy with imatinib or interferon
- HIV positivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase With Age More Than 70, Diagnosis of CML is Being Performed Within 1 Year
The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis of cml is being performed within 1 year. Quality of life will be carefully assessed.
Read the detailed description
Patients will received Imatinib at a dose of 400mg daily. Tolerability and quality of life will be assessed Secondary objectives are : to evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.
Duration of responses and failure to respond will be evaluated.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Imatinib mesylate 400 mg
- Keywords
- CML - ederly patients - 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 400 mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability
Quality of life
Secondary outcomes (5)
. the survival without progression
. the survival without event
. the overall survival
. the hematologic cytogenetic and molecular responses at various check points.
. duration of responses and failure to respond
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2002
- Study completionMay 2007
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 Poitiers University HospitalThe 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
- 30 participants
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- François GUILHOT, MD, Study chair, Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCEPhilippe ROUSSELOT, MD, Principal investigator, Department of Hematology and Oncology - University Hospital "Saint Louis" - 75475 PARIS cedex 10 (FRANCE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219752
- Sponsor's protocol ID
- 020948
- Other IDs
- CSTI571AFR04
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 22 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase With Age More Than 70, Diagnosis of CML is Being Performed Within 1 Year
- ClinicalTrials.gov ID
- NCT00219752
- Acronym / sponsor ID
- 020948
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- CML - ederly patients - Imatinib mesylate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- May 2002
- Study completion
- May 2007
- First posted
- 22 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.
The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis of cml is being performed within 1 year. Quality of life will be carefully assessed.
Detailed description
Patients will received Imatinib at a dose of 400mg daily. Tolerability and quality of life will be assessed Secondary objectives are : to evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.
Duration of responses and failure to respond will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- CML Ph+ (assessed by cytogenetic or FISH)
- Chronic phase with less than 5% bone marrow blasts
- Diagnosis within 12 months
- Age ≥ 70 year at inclusion
- PS grade 0 to 2 (ECOG)
Key exclusion criteria (7 listed)
- patients who cannot sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
- Mini mental status ≤ 25
- patients who are not able to adequately take the study drug
- Age less than 70 y
- accelerated or blastic phase
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 400 mg | Drug | – |
Primary outcome
Tolerability
Quality of life
5 secondary outcomes
. the survival without progression
. the survival without event
. the overall survival
. the hematologic cytogenetic and molecular responses at various check points.
. duration of responses and failure to respond
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 22 Dec 2005.
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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.
François GUILHOT, MD study chair
Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
Philippe ROUSSELOT, MD principal investigator
Department of Hematology and Oncology - University Hospital "Saint Louis" - 75475 PARIS cedex 10 (FRANCE)
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 400 mg in people with Chronic Myeloid Leukemia, run by Poitiers University Hospital 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 8 inclusion and 7 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 22 Dec 2005. 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?
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?
Tolerability. The study lists 2 primary outcomes in all. 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 22 Dec 2005.