Chronic Myeloid LeukaemiaSTIM 2NCT01343173
Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib
A study testing Imatinib stop in people with Chronic Myeloid Leukaemia, run by University Hospital, Bordeaux at 32 sites in France.
Trial summary
Background: Complete molecular remission under imatinib, therapeutic interruption possible for patients in complete remission proved in different trials. Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular remission during two following years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukaemia
- What is being tested?
- Imatinib stop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 32 sitesFrance
- Study dates
- 6 Apr 2011to 30 May 2017
- 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
- 18 years and older.
- Chronic myeloid leukaemia in chronic or accelerated phase under treatment with imatinib for at least 3 years.
- Complete molecular remission under treatment with imatinib for at least 2 years.
- HIV serology negative and absence of chronic hepatitis B or C.
- Molecular monitoring according to the international recommendations before the beginning of the study
- For the women old enough to procreate, method of effective contraception
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
Who cannot join
- Under 18 years old.
- Pregnant at the inclusion's time.
- Hospitalized patients without consent.
- Adults under law protection or without ability to assent.
- Previous or planned allogeneic stem cell transplantation.
- HIV serology positive or chronic hepatitis B or C.
- Interfering treatment (corticosteroids, immunosuppressors, chemotherapy, radiotherapy).
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
France32 sites
University Hospital Angers
Angers, 49033
CH Annecy
Annecy
CHU Bensançon
Besançon
Institut Bergonié
Bordeaux, 33076
Hôpital Morvan
Brest, 29285
CHU Caen
Caen
Hôpitaux civils de Colmar
Colmar, 68000
CH Sud Francilien
Corbeil-Essonnes
Hôpital Henri-Mondor
Créteil, 94000
CHU Grenoble
Grenoble, 38043
Centre Hospitalier - La Roche sur Yon
La Roche-sur-Yon, 85025
Lille University hospital - Hôpital Claude Huriez
Lille, 59037
CHU Dupuytren
Limoges
Hôpital Edouard Herriot
Lyon, 69374
Institut Paoli Calmette
Marseille, 13273
CHU Hôtel-Dieu
Nantes, 44035
Centre Hospitalier de Nevers
Nevers, 58033
CHU de Nice - Hôpital Archet 1
Nice, 06202
Hôpital Saint Louis
Paris, 75475
Hôpital Necker-Enfants Malades
Paris, 75743
University Hospital Bordeaux, Hôpital du Haut Lévêque
Pessac, 33604
University Hospital Poitiers - Hôpital Jean Bernard
Poitiers, 86021
Hôpital Pontchaillou
Rennes, 35033
Centre Henri Becquerel
Rouen
CH Yves Le Foll
Saint-Brieuc
CHR La Réunion
Saint-Denis, 97405
CH Régional de l'ILE DE LA REUNION/ Groupe Hospitalier Sud
Saint-Pierre
Hôpital Purpan
Toulouse, 31059
CH Valence
Valence
C.H.U. Brabois
Vandœuvre-lès-Nancy, 54500
CH Bretagne Atlantique
Vannes
Centre Hospitalier de Versailles - Hôpital André Mignot
Versailles, 78157
About this study
Background: Complete molecular remission under imatinib, therapeutic interruption possible for patients in complete remission proved in different trials.
Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular remission during two following years. The objectives of this study are to determine the rate of patients without a molecular relapse and so the rate of molecular relapse, to determine and to seek for clinical and biological CML-related factors predictive for a molecular relapse after imatinib discontinuation. These objectives require to increase the number of study patients to be enrolled for accurate statistical considerations. It will allow to predict which patients have to be proposed for discontinuation without risk of molecular relapse and to select the patients who need to continue or reinforce the treatment to achieve a complete long term eradication of the disease.
Read the detailed description
The gold standard for the treatment of chronic myeloid leukaemia (CML) is Imatinib, the first tyrosine inhibitor (TKI) of BCR-ABL. Imatinib specifically targets the BCR-ABL tyrosine kinase encoded by the BCR-ABL fusion gene, the molecular hallmark of CML. Regular monitoring of BCR-ABL transcript levels by quantitative RT-PCR is of key importance for the assessment of treatment response to imatinib.
Over time, an increasing proportion of imatinib-treated patients obtain a complete molecular response (CMR), defined as an undetectable molecular residual disease. In a previous study, STIM trial (PHRC 2006, stop Imatinib), 100 patients were included. The preliminary analysis among 69 patients having a median follow up of 21 months shows that the probability to maintain the CMR at 12 months is 45%. Our goal is actually to include up to 200 patients and then let the STIM opened during 3 years in a way to determine the predictive factors of the molecular relapse Discontinuation of treatment is proposed after checking selection criteria and signing informed consent. The assessment of BCR-ABL in peripheral blood by quantitative RT-PCR is performed every month during the first year then every two months second year then every three months during 3 years.
The molecular relapse after imatinib discontinuation is defined by positive PCR for BCR-ABL two times using RTQ-PCR with increasing of the transcript on two following assessment and or a value> 0.1% i.e. lost of MMR. In case of molecular relapse it is recommended to re-challenge an imatinib treatment. According to our experience the 50 patients well documented who re challenged the treatment were sensitive again. The treatment of molecular relapse by second generation tyrosine kinase inhibitors (dasatinib or nilotinib) will possible in the current trial. It is important for all the French patients to be included in a national trial to avoid discontinuation without evaluation.
- Conditions
- Chronic Myeloid Leukaemia
- Being tested
- Imatinib stop
- 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 stopDrug
To stop imatinib after inclusion.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Drug: Imatinib stop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of molecular relapse defined by the rate of patients having a significant increasing of BCR-ABL transcript.
Measured: Every months during two years
Secondary outcomes (4)
Overall survival
Number of patients alive or died will be measured
Measured: after two years
Clinical and biological profile of patient with complete molecular remission persistence
The relevant clinical and biological factors which could be predictive of the the complete molecular remission persistence will be measured by dosage in the blood.
Measured: after two years
Treatment costs according to days without imatinib.
Measured: after two years
Event-free survival
All adverse events will be reported to know what kind of adverse events occured to patients without treatment, number of patients with adverse events and in particular number of patients with lost of complete molecular remission.
Measured: after two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study start6 Apr 2011
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid LeukaemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François-Xavier MAHON, Pr, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343173
- Sponsor's protocol ID
- CHUBX 2010/25
- Other IDs
- 2011-000068-91
- Acronym
- STIM 2
- Status last verified
- Mar 2018
- First submitted
- 23 Mar 2011
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alcazer V, Dulucq S, Mosnier I, Chabane K, Bertin-Mourot P, Derruau S, Balsat M, Labussiere-Wallet H, Sujobert P, Mahon FX, Etienne G, Nicolini F, Hayette S. Development and External Validation of a Transcriptome-Based Multivariable Prediction Model for Treatment-Free Remission in Chronic Myeloid Leukemia. J Clin Oncol. 2026 Jul 20;44(21):1992-2005. doi: 10.1200/JCO-25-02948. Epub 2026 Jun 9.
PubMed 42454992
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib
- ClinicalTrials.gov ID
- NCT01343173
- Acronym / sponsor ID
- STIM 2 / CHUBX 2010/25
- Conditions
- Chronic Myeloid Leukaemia
- Keywords
- Leukemia, Adult Chronic, Myeloid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 6 Apr 2011 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 27 Apr 2011 (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.
Background: Complete molecular remission under imatinib, therapeutic interruption possible for patients in complete remission proved in different trials.
Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular remission during two following years. The objectives of this study are to determine the rate of patients without a molecular relapse and so the rate of molecular relapse, to determine and to seek for clinical and biological CML-related factors predictive for a molecular relapse after imatinib discontinuation. These objectives require to increase the number of study patients to be enrolled for accurate statistical considerations. It will allow to predict which patients have to be proposed for discontinuation without risk of molecular relapse and to select the patients who need to continue or reinforce the treatment to achieve a complete long term eradication of the disease.
Detailed description
The gold standard for the treatment of chronic myeloid leukaemia (CML) is Imatinib, the first tyrosine inhibitor (TKI) of BCR-ABL. Imatinib specifically targets the BCR-ABL tyrosine kinase encoded by the BCR-ABL fusion gene, the molecular hallmark of CML. Regular monitoring of BCR-ABL transcript levels by quantitative RT-PCR is of key importance for the assessment of treatment response to imatinib.
Over time, an increasing proportion of imatinib-treated patients obtain a complete molecular response (CMR), defined as an undetectable molecular residual disease. In a previous study, STIM trial (PHRC 2006, stop Imatinib), 100 patients were included. The preliminary analysis among 69 patients having a median follow up of 21 months shows that the probability to maintain the CMR at 12 months is 45%. Our goal is actually to include up to 200 patients and then let the STIM opened during 3 years in a way to determine the predictive factors of the molecular relapse Discontinuation of treatment is proposed after checking selection criteria and signing informed consent. The assessment of BCR-ABL in peripheral blood by quantitative RT-PCR is performed every month during the first year then every two months second year then every three months during 3 years.
The molecular relapse after imatinib discontinuation is defined by positive PCR for BCR-ABL two times using RTQ-PCR with increasing of the transcript on two following assessment and or a value> 0.1% i.e. lost of MMR. In case of molecular relapse it is recommended to re-challenge an imatinib treatment. According to our experience the 50 patients well documented who re challenged the treatment were sensitive again. The treatment of molecular relapse by second generation tyrosine kinase inhibitors (dasatinib or nilotinib) will possible in the current trial. It is important for all the French patients to be included in a national trial to avoid discontinuation without evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Drug: Imatinib stop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years and older.
- Chronic myeloid leukaemia in chronic or accelerated phase under treatment with imatinib for at least 3 years.
- Complete molecular remission under treatment with imatinib for at least 2 years.
- HIV serology negative and absence of chronic hepatitis B or C.
- Molecular monitoring according to the international recommendations before the beginning of the study
Key exclusion criteria (7 listed)
- Under 18 years old.
- Pregnant at the inclusion's time.
- Hospitalized patients without consent.
- Adults under law protection or without ability to assent.
- Previous or planned allogeneic stem cell transplantation.
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 stopTo stop imatinib after inclusion. | Drug | Patients |
Primary outcome
Rate of molecular relapse defined by the rate of patients having a significant increasing of BCR-ABL transcript.
Time frame: Every months during two years
4 secondary outcomes
Overall survival
Time frame: after two years
Clinical and biological profile of patient with complete molecular remission persistence
Time frame: after two years
Treatment costs according to days without imatinib.
Time frame: after two years
Event-free survival
Time frame: after two 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 31 Jul 2026.
- Results publication: PubMed 42454992Alcazer V, Dulucq S, Mosnier I, Chabane K, Bertin-Mourot P, Derruau S, Balsat M, Labussiere-Wallet H, Sujobert P, Mahon FX, Etienne G, Nicolini F, Hayette S. Development and External Validation of a Transcriptome-Based Multivariable Prediction Model for Treatment-Free Remission in Chronic Myeloid Leukemia. J Clin Oncol. 2026 Jul 20;44(21):1992-2005. doi: 10.1200/JCO-25-02948. Epub 2026 Jun 9.
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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, Pr principal investigator
University Hospital Bordeaux, France
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imatinib stop in people with Chronic Myeloid Leukaemia, run by University Hospital, Bordeaux at 32 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 7 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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?
Rate of molecular relapse defined by the rate of patients having a significant increasing of BCR-ABL transcript. (time frame: Every months during two years). 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 NCT01343173, which also lists 1 linked publication.
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 31 Jul 2026.