Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
NCT ID: NCT02896829
Last Updated: 2020-06-19
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
97 participants
OBSERVATIONAL
2013-04-03
2019-04-30
Brief Summary
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Detailed Description
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CML patients treated with TKI are monitored by BCR-ABL1 RT-qPCR (Reverse Transcription real-time quantitative Polymerase Chain Reaction) performed from peripheral blood samples.
A first multicenter study entitled STIM trial demonstrated that imatinib could be safely discontinued in patients with complete molecular remission (CMR) for at least 2 years (undetectable BCR-ABL1 transcript by RT-qPCR).
Around 40% of these patients remain in a prolonged treatment-free remission (TFR) after treatment cessation. All molecular relapsing patients were sensitive when imatinib was re-challenged.
The purpose of this STIM-FU study is to follow all the patients included in the STIM trial in order to evaluate their molecular status, vital status and ongoing treatment in patient with a first molecular relapse.
This long term follow up will allow us to predict if a constant long term control of the disease is possible and to better define the clinical and biological CML-related factors predictive for a molecular relapse after TKI discontinuation.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Imatinib treatment ending
Interruption of the treatment by Imatinib
Interruption of the treatment by Imatinib
Interventions
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Interruption of the treatment by Imatinib
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Locations
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CHU d'Angers
Angers, , France
Institut Bergonié
Bordeaux, , France
CHU de Bordeaux - Haut-Lévêque
Bordeaux, , France
Hôpital Morvan
Brest, , France
Hôpital Henri-Mondor
Créteil, , France
Pôle de cancérologie
Grenoble, , France
Centre Hospitalier de La Roche Sur Yon
La Roche-sur-Yon, , France
Centre Hospitalier de Versailles
Le Chesnay, , France
Hôpital Claude Huriez
Lille, , France
Hôpital Edouard Herriot
Lyon, , France
Institut Paoli Calmette
Marseille, , France
CHU Hôtel-Dieu
Nantes, , France
CHU de Nice
Nice, , France
Hôpital Saint Louis
Paris, , France
Hôpital Necker-Enfants Malades
Paris, , France
CHU de Poitiers
Poitiers, , France
Hôpital Civil
Strasbourg, , France
Hôpital Purpan
Toulouse, , France
CHU Brabois
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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CHUBX 2012/06
Identifier Type: -
Identifier Source: org_study_id
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