Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
NCT ID: NCT00478985
Last Updated: 2013-07-02
Study Results
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Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2007-06-30
2011-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Imatinib treatment ending
Imatinib ending
Interruption of the treatment by Imatinib
Interventions
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Imatinib ending
Interruption of the treatment by Imatinib
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
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, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux, France
Locations
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University Hospital Angers
Angers, Angers, France
Hôpital Morvan
Brest, Brest, France
Hôpital Henri-Mondor
Créteil, Créteil, France
Hôpital Claude Huriez
Lille, Lille, France
University Hospital Hôtel-Dieu
Nantes, Nantes, France
Hôpital Saint Louis
Paris, Paris, France
University Hospital Poitiers
Poitiers, Poitiers, France
University Hospital Toulouse, Purpan
Toulouse, Toulouse, France
University Hospital Brabois
Vandœuvre-lès-Nancy, Vandoeuvre Les Nancy, France
Institut Bergonié
Bordeaux, , France
University Hospital Bordeaux, Groupe Hospitalier Pellegrin
Bordeaux, , France
CHU de Grenoble
Grenoble, , France
Centre hospitalier-service de médecine interne Onco-Hématologique
La Roche-sur-Yon, , France
Hôpital André Mignot
Le Chesnay, , France
Hôpital Bicêtre, AP-HP
Le Kremlin-Bicêtre, , France
Hôpital Edouard Herriot
Lyon, , France
Institut Paoli Calmet
Marseille, , France
CHR de Metz-Thionville
Metz, , France
Centre Hospitalier de Nevers
Nevers, , France
University Hospital Nice
Nice, , France
Hôpital Necker-Enfants Malades
Paris, , France
Haut Lévêque Hospital
Pessac, , France
University Hospital Strasbourg, Hôpital Civil
Strasbourg, , France
Centre Hospitalier Bretagne Atlantique
Vannes, , France
Countries
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References
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Rea 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.
Mahon 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.
Other Identifiers
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CHUBX 2006/06
Identifier Type: -
Identifier Source: org_study_id
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