Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib
NCT ID: NCT01343173
Last Updated: 2018-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2011-04-06
2017-05-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients
Imatinib stop
To stop imatinib after inclusion.
Interventions
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Imatinib stop
To stop imatinib after inclusion.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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François-Xavier MAHON, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux, France
Locations
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University Hospital Angers
Angers, , France
CH Annecy
Annecy, , France
CHU Bensançon
Besançon, , France
Institut Bergonié
Bordeaux, , France
Hôpital Morvan
Brest, , France
CHU Caen
Caen, , France
Hôpitaux civils de Colmar
Colmar, , France
CH Sud Francilien
Corbeil-Essonnes, , France
Hôpital Henri-Mondor
Créteil, , France
CHU Grenoble
Grenoble, , France
Centre Hospitalier - La Roche sur Yon
La Roche-sur-Yon, , France
Lille University hospital - Hôpital Claude Huriez
Lille, , France
CHU Dupuytren
Limoges, , France
Hôpital Edouard Herriot
Lyon, , France
Institut Paoli Calmette
Marseille, , France
CHU Hôtel-Dieu
Nantes, , France
Centre Hospitalier de Nevers
Nevers, , France
CHU de Nice - Hôpital Archet 1
Nice, , France
Hôpital Saint Louis
Paris, , France
Hôpital Necker-Enfants Malades
Paris, , France
University Hospital Bordeaux, Hôpital du Haut Lévêque
Pessac, , France
University Hospital Poitiers - Hôpital Jean Bernard
Poitiers, , France
Hôpital Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
CH Yves Le Foll
Saint-Brieuc, , France
CHR La Réunion
Saint-Denis, , France
CH Régional de l'ILE DE LA REUNION/ Groupe Hospitalier Sud
Saint-Pierre, , France
Hôpital Purpan
Toulouse, , France
CH Valence
Valence, , France
C.H.U. Brabois
Vandœuvre-lès-Nancy, , France
CH Bretagne Atlantique
Vannes, , France
Centre Hospitalier de Versailles - Hôpital André Mignot
Versailles, , France
Countries
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Other Identifiers
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CHUBX 2010/25
Identifier Type: -
Identifier Source: org_study_id
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