Myeloid Leukemia, ChronicSTIMNCT00478985
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
A study testing Imatinib ending in people with Myeloid Leukemia, Chronic, run by University Hospital, Bordeaux at 24 sites in France.
Trial summary
The first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for bcr-abl transcripts). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Leukemia, Chronic
- What is being tested?
- Imatinib ending
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 24 sitesFrance
- Study dates
- Jun 2007to Dec 2011
- Phase
- Interventional
- 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 reached their 18th birthday
- Women of childbearing potential must agree to use effective methods of contraception
- Patients must be affiliated to a social security regime
- Patients must have received imatinib therapy for at least 36 months.
- Patients must be in complete molecular remission during at least two consecutive years with at least five RT-PCR negative measures for bcr-abl transcripts.
- Patients must be HIV, HCV and HBV negatives
- Patients who have molecular follow-up realized in accordance with international recommendations
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
Who cannot join
- Patients who are protected by the law. Patients who are unable to give their consent to participate to the study.
- Patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping imatinib. Patients who have pathologies or treatments which able to interfere with immunologic study (excepted IFN α):
- Corticosteroids or other immuno suppressors Other concomitant malign pathology treated by chemotherapy or radiotherapy Previous or programmed Haematopoietic Stem Cell allogreffe
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
University Hospital Angers
Angers, Angers, 49033
Institut Bergonié
Bordeaux, 33076
University Hospital Bordeaux, Groupe Hospitalier Pellegrin
Bordeaux, 33076
Hôpital Morvan
Brest, Brest, 29285
Hôpital Henri-Mondor
Créteil, Créteil, 94000
CHU de Grenoble
Grenoble, 38043
Centre hospitalier-service de médecine interne Onco-Hématologique
La Roche-sur-Yon, 85025
Hôpital André Mignot
Le Chesnay, 78157
Hôpital Bicêtre, AP-HP
Le Kremlin-Bicêtre, 94275
Hôpital Claude Huriez
Lille, Lille, 59037
Hôpital Edouard Herriot
Lyon, 69374
Institut Paoli Calmet
Marseille, 13273
CHR de Metz-Thionville
Metz, 57038
University Hospital Hôtel-Dieu
Nantes, Nantes, 44035
Centre Hospitalier de Nevers
Nevers, 58033
University Hospital Nice
Nice, 06202
Hôpital Saint Louis
Paris, Paris, 75475
Hôpital Necker-Enfants Malades
Paris, 75743
Haut Lévêque Hospital
Pessac, 33604
University Hospital Poitiers
Poitiers, Poitiers, 86021
University Hospital Strasbourg, Hôpital Civil
Strasbourg, 67000
University Hospital Toulouse, Purpan
Toulouse, Toulouse, 31059
University Hospital Brabois
Vandœuvre-lès-Nancy, Vandoeuvre Les Nancy, 54500
Centre Hospitalier Bretagne Atlantique
Vannes, 56 017
About this study
Official title: Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)
The first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for bcr-abl transcripts). The second purpose is to determine clinicals and biologicals factors associated with the persistent complete molecular remission.
Read the detailed description
Principal Objective : To evaluate the complete molecular remission persistence after stopping imatinib during six months as measured by RT-PCR negative for bcr-abl transcripts in patients with Chronic Myeloid Leukemia .
Secondary Objective :
- To determine clinicals factors associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukemia.
- To determine the biologics factors (immunologic and molecular) associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukaemia.
- To determine the molecular relapse level after more than six month of persistent complete molecular remission without imatinib.
- To determine the complete molecular remission length.
- To evaluate medical and economical impact of stopping imatinib treatment.
Study design : multicentric trial
- Conditions
- Myeloid Leukemia, Chronic
- Being tested
- Imatinib ending
- Keywords
- Leukemia, Adult Chronic, Myeloid
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib endingBehavioural
Interruption of the treatment by Imatinib
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Imatinib treatment ending Receives: Behavioral: Imatinib ending |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts
Measured: Every month during the first year and every two months during the second year
Secondary outcomes (4)
T lymphocytes differenciation and proliferation analyse / cytokines production analyse
Measured: first visit, M2,M4,M6,M9,M12,M18,M24
T lymphocytes apoptosis analyse
Measured: first visit
Haemogramme analyse
Measured: every months during two years
Clinical exam
Measured: every three months during the first year and every four months during the second year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myeloid Leukemia, ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François-Xavier MAHON, MD, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478985
- Sponsor's protocol ID
- CHUBX 2006/06
- Acronym
- STIM
- Status last verified
- Jul 2013
- First submitted
- 23 May 2007
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mahon FX, Dulucq S, Rea D, Nicolini FE, Rigal-Huguet F, Machova Polakova K, Dubruille V, Noel MP, Ianotto JC, Villemagne B, Cayssials E, Park S, Rousselot P, Etienne G. Extended long-term follow-up and the survival of Stop Imatinib study. Blood Neoplasia. 2025 Oct 27;3(1):100177. doi: 10.1016/j.bneo.2025.100177. eCollection 2026 Feb.
PubMed 41574312Rea D, Henry G, Khaznadar Z, Etienne G, Guilhot F, Nicolini F, Guilhot J, Rousselot P, Huguet F, Legros L, Gardembas M, Dubruille V, Guerci-Bresler A, Charbonnier A, Maloisel F, Ianotto JC, Villemagne B, Mahon FX, Moins-Teisserenc H, Dulphy N, Toubert A. Natural killer-cell counts are associated with molecular relapse-free survival after imatinib discontinuation in chronic myeloid leukemia: the IMMUNOSTIM study. Haematologica. 2017 Aug;102(8):1368-1377. doi: 10.3324/haematol.2017.165001. Epub 2017 May 18.
PubMed 28522576Mahon FX, Rea D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Francais des Leucemies Myeloides Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19.
PubMed 20965785
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)
- ClinicalTrials.gov ID
- NCT00478985
- Acronym / sponsor ID
- STIM / CHUBX 2006/06
- Conditions
- Myeloid Leukemia, Chronic
- Keywords
- Leukemia, Adult Chronic, Myeloid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 May 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.
The first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for bcr-abl transcripts). The second purpose is to determine clinicals and biologicals factors associated with the persistent complete molecular remission.
Detailed description
Principal Objective : To evaluate the complete molecular remission persistence after stopping imatinib during six months as measured by RT-PCR negative for bcr-abl transcripts in patients with Chronic Myeloid Leukemia .
Secondary Objective :
- To determine clinicals factors associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukemia.
- To determine the biologics factors (immunologic and molecular) associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukaemia.
- To determine the molecular relapse level after more than six month of persistent complete molecular remission without imatinib.
- To determine the complete molecular remission length.
- To evaluate medical and economical impact of stopping imatinib treatment.
Study design : multicentric trial
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Imatinib endingImatinib treatment ending |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have reached their 18th birthday
- Women of childbearing potential must agree to use effective methods of contraception
- Patients must be affiliated to a social security regime
- Patients must have received imatinib therapy for at least 36 months.
- Patients must be in complete molecular remission during at least two consecutive years with at least five RT-PCR negative measures for bcr-abl transcripts.
Key exclusion criteria (3 listed)
- Patients who are protected by the law. Patients who are unable to give their consent to participate to the study.
- Patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping imatinib. Patients who have pathologies or treatments which able to interfere with immunologic study (excepted IFN α):
- Corticosteroids or other immuno suppressors Other concomitant malign pathology treated by chemotherapy or radiotherapy Previous or programmed Haematopoietic Stem Cell allogreffe
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 endingInterruption of the treatment by Imatinib | Behavioural | 1 |
Primary outcome
Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts
Time frame: Every month during the first year and every two months during the second year
4 secondary outcomes
T lymphocytes differenciation and proliferation analyse / cytokines production analyse
Time frame: first visit, M2,M4,M6,M9,M12,M18,M24
T lymphocytes apoptosis analyse
Time frame: first visit
Haemogramme analyse
Time frame: every months during two years
Clinical exam
Time frame: every three months during the first year and every four months during the second year
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 2 Jul 2013.
- Derived from this study: PubMed 41574312Mahon FX, Dulucq S, Rea D, Nicolini FE, Rigal-Huguet F, Machova Polakova K, Dubruille V, Noel MP, Ianotto JC, Villemagne B, Cayssials E, Park S, Rousselot P, Etienne G. Extended long-term follow-up and the survival of Stop Imatinib study. Blood Neoplasia. 2025 Oct 27;3(1):100177. doi: 10.1016/j.bneo.2025.100177. eCollection 2026 Feb.
- Derived from this study: PubMed 28522576Rea D, Henry G, Khaznadar Z, Etienne G, Guilhot F, Nicolini F, Guilhot J, Rousselot P, Huguet F, Legros L, Gardembas M, Dubruille V, Guerci-Bresler A, Charbonnier A, Maloisel F, Ianotto JC, Villemagne B, Mahon FX, Moins-Teisserenc H, Dulphy N, Toubert A. Natural killer-cell counts are associated with molecular relapse-free survival after imatinib discontinuation in chronic myeloid leukemia: the IMMUNOSTIM study. Haematologica. 2017 Aug;102(8):1368-1377. doi: 10.3324/haematol.2017.165001. Epub 2017 May 18.
- Derived from this study: PubMed 20965785Mahon FX, Rea D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Francais des Leucemies Myeloides Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19.
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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-Xavier MAHON, MD principal investigator
University Hospital Bordeaux, France
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imatinib ending in people with Myeloid Leukemia, Chronic, run by University Hospital, Bordeaux at 24 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 8 inclusion and 3 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 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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.
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?
Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts (time frame: Every month during the first year and every two months during the second year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00478985, which also lists 3 linked publications.
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 2 Jul 2013.