Leukemia, Myelocytic, AcutePhase 2NCT00446303
A Phase II Study of Maintenance With Azacitidine in MDS Patients
A Phase 2 study testing Azacitidine in people with Leukemia, Myelocytic, Acute and Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 25 sites in France.
Trial summary
A phase II multicentre trial of maintenance with Azacitidine in MDS patients achieving complete or partial remission (CR or PR) after intensive chemoterapy. The primary objective is response duration (MDS or AML) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Leukemia, Myelocytic, Acute, Myelodysplastic Syndromes
- What is being tested?
- Azacitidine
- How many people
- 39 participants
- Where
- 25 sitesFrance
- Study dates
- Jul 2006to Jul 2010
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MDS with int 2 or high IPSS score eitherRAEB 1 or 2 according to the WHO classification (see appendix 1) or CMML with WBC < 13 109/l RAEB-T according to the FAB classification (see appendix 1) without t(8 ;21), inv 16 or t(16;16) AML secondary to MDS (sAML) with a confirmed MDS phase of at least 2 months with available bone marrow cytogenetics at diagnosis of AML
- AND
- in CR or PR according to IWG criteria (see appendix 3) after one or two courses of predefined intensive chemotherapy (see page 12) with available cytogenetics at evaluation of response Aged 18 years of age or more Written Informed consent Adequate Contraception, if relevant Negative pregnancy test if relevant. Patients not eligible for the azacitidine confirmatory trial (azacitidine " versus " conventional treatment ") or unwilling to participate to it
Who cannot join
- AML secondary to myeloproliferative or MDS/MPD WHO subgroups except CMML with WBC< 13 109/l
- Therapy related MDS (after chemo or radiotherapy for a previous neoplasm or immune disorder)
- Patients eligible for allogeneic bone marrow transplantation (with a identified donor)
- Liver and/or kidney failures prohibiting the use of azacitidine. Creatininemia > 1.5 normal value ALAT and ASAT > 3N
- Bilirubin > 2 N, unless due to dyserythropoiesis
- Known hypersensitivity to azacitidine or mannitol
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- Other tumor, unstable for the last three years, except in situ uterine carcinoma or basal skin tumor
- Uncontrolled infection,
- WHO Performance status > 2
- Life expectancy less than 3 months
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
CHU d'Amiens
Amiens, 80054
CHU Angers
Angers, 49033
CH d'Avignon
Avignon, 84000
CHU de Caen
Caen, 14033
Hopital d'Instruction des Armées Percy
Clamart, 92140
Hopital Henri Mondor
Créteil, 94000
CHU de Dijon
Dijon, 21034
CHU Albert Michallon
Grenoble, 38043
CHRU Hurriez
Lille, 59057
CHRU de Limoges
Limoges, 87046
Hopital Edouard Herriot
Lyon, 69437
Hopital Paoli Calmette
Marseille, 13273
Hopital Hotel Dieu
Nantes, 44093
Hopital Archet
Nice, 06202
Hopital Saint Louis
Paris, 75475
Hopital Saint Antoine
Paris, 75571
Hopital Cochin
Paris, 75679
Hopital Haut Leveque
Pessac, 33604
Hopital Jean-Bernard
Poitiers, 86021
CHRU de Reims
Reims, 51092
CHU Pontchaillou
Rennes, 35033
Hopital Hautepierre
Strasbourg, 67098
Hopital Purpan
Toulouse, 31031
CHU Brabois
Vandœuvre-lès-Nancy, 54511
CH Versailles
Versailles, 78000
About this study
Official title: A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy
A phase II multicentre trial of maintenance with Azacitidine in MDS patients achieving complete or partial remission (CR or PR) after intensive chemoterapy.
The primary objective is response duration (MDS or AML)
Read the detailed description
A academic multicentre study whose aims are to study the benefits of a maintenance therapy with 24 monthly courses af azacytidine in high-risk MDS patients, previously treated with intensive chemotherapy with obtention of a partial or complete response and not eligible for allogeneic transplantation
- Being tested
- Azacitidine
- Keywords
- MDS, Myelodysplastic Syndromes, AML, Intensive chemotherapy, azacitidine
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Azacitidine 60mg/m2 /d for 5 days every 28 days, for 24 months (parallel study to the ongoing NMDSG study.
Extension of maintenance in responders after 24 courses until relapse or death.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reponse duration and cumulative incidence of relapses
Measured: 1-24 months
Secondary outcomes (2)
Toxicity according to WHO
Measured: 1-24 months
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2007 (estimated)
- Study startJul 2006
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myelocytic, AcuteStudies of the same condition, open and under way.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Francophone des Myelodysplasies
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Claude GARDIN, MD, Principal investigator, Groupe Francophone des Myelodysplasies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446303
- Sponsor's protocol ID
- GFM aza05
- Status last verified
- Jun 2010
- First submitted
- 9 Mar 2007
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy
- ClinicalTrials.gov ID
- NCT00446303
- Acronym / sponsor ID
- GFM aza05
- Keywords
- MDS, Myelodysplastic Syndromes, AML, Intensive chemotherapy, azacitidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Groupe Francophone des MyelodysplasiesUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jul 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Mar 2007 (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.
A phase II multicentre trial of maintenance with Azacitidine in MDS patients achieving complete or partial remission (CR or PR) after intensive chemoterapy.
The primary objective is response duration (MDS or AML)
Detailed description
A academic multicentre study whose aims are to study the benefits of a maintenance therapy with 24 monthly courses af azacytidine in high-risk MDS patients, previously treated with intensive chemotherapy with obtention of a partial or complete response and not eligible for allogeneic transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MDS with int 2 or high IPSS score eitherRAEB 1 or 2 according to the WHO classification (see appendix 1) or CMML with WBC < 13 109/l RAEB-T according to the FAB classification (see appendix 1) without t(8 ;21), inv 16 or t(16;16) AML secondary to MDS (sAML) with a confirmed MDS phase of at least 2 months with available bone marrow cytogenetics at diagnosis of AML
- AND
- in CR or PR according to IWG criteria (see appendix 3) after one or two courses of predefined intensive chemotherapy (see page 12) with available cytogenetics at evaluation of response Aged 18 years of age or more Written Informed consent Adequate Contraception, if relevant Negative pregnancy test if relevant. Patients not eligible for the azacitidine confirmatory trial (azacitidine " versus " conventional treatment ") or unwilling to participate to it
Key exclusion criteria (10 listed)
- AML secondary to myeloproliferative or MDS/MPD WHO subgroups except CMML with WBC< 13 109/l
- Therapy related MDS (after chemo or radiotherapy for a previous neoplasm or immune disorder)
- Patients eligible for allogeneic bone marrow transplantation (with a identified donor)
- Liver and/or kidney failures prohibiting the use of azacitidine. Creatininemia > 1.5 normal value ALAT and ASAT > 3N
- Bilirubin > 2 N, unless due to dyserythropoiesis
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 |
|---|---|---|
| AzacitidineAzacitidine 60mg/m2 /d for 5 days every 28 days, for 24 months (parallel study to the ongoing NMDSG study. Extension of maintenance in responders after 24 courses until relapse or death. | Drug | – |
Primary outcome
Reponse duration and cumulative incidence of relapses
Time frame: 1-24 months
2 secondary outcomes
Toxicity according to WHO
Time frame: 1-24 months
Overall survival
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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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.
Claude GARDIN, MD principal investigator
Groupe Francophone des Myelodysplasies
25 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 Azacitidine in people with Leukemia, Myelocytic, Acute and Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 25 sites 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 3 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: stopped early, as of the sponsor's last update on 19 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 25 sites 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 was stopped early. 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?
Reponse duration and cumulative incidence of relapses (time frame: 1-24 months). 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 19 Jan 2012.