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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-03

Study Completion Date

2019-04-30

Brief Summary

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It's an observational study based on 98 patients included in the STIM trial to extend the monitoring of patients and to have molecular and clinical data, with long follow up. Are there late relapses? What has become patients who relapsed during STIM trial and restarted TKI (inhibitor tyrosine kinase) treatment?

Detailed Description

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Chronic myeloid leukemia (CML) is an hematopoietic stem cell disorder in which a t (9;22) (q34;q11) reciprocal chromosomal translocation gives rise to Philadelphia chromosome (Ph) and generates the BCR-ABL1 fusion gene encoding a constitutively activated protein tyrosine kinases (PTK). Tyrosine kinase Inibitors (TKIs) such as imatinib, by blocking BCR-ABL1 kinase activity, selectively eradicate CML cells and induce durable responses and prolong survival.

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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Chronic Myeloid Leukemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Imatinib treatment ending

Interruption of the treatment by Imatinib

Interruption of the treatment by Imatinib

Intervention Type BEHAVIORAL

Interventions

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Interruption of the treatment by Imatinib

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* The patients should have been included in the STIM1 Study CHUBX 2006/06 (NCT00478985)

Exclusion Criteria

* The patients not included or discharged prematurely from the STIM1 Study can not participate to the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU d'Angers

Angers, , France

Site Status

Institut Bergonié

Bordeaux, , France

Site Status

CHU de Bordeaux - Haut-Lévêque

Bordeaux, , France

Site Status

Hôpital Morvan

Brest, , France

Site Status

Hôpital Henri-Mondor

Créteil, , France

Site Status

Pôle de cancérologie

Grenoble, , France

Site Status

Centre Hospitalier de La Roche Sur Yon

La Roche-sur-Yon, , France

Site Status

Centre Hospitalier de Versailles

Le Chesnay, , France

Site Status

Hôpital Claude Huriez

Lille, , France

Site Status

Hôpital Edouard Herriot

Lyon, , France

Site Status

Institut Paoli Calmette

Marseille, , France

Site Status

CHU Hôtel-Dieu

Nantes, , France

Site Status

CHU de Nice

Nice, , France

Site Status

Hôpital Saint Louis

Paris, , France

Site Status

Hôpital Necker-Enfants Malades

Paris, , France

Site Status

CHU de Poitiers

Poitiers, , France

Site Status

Hôpital Civil

Strasbourg, , France

Site Status

Hôpital Purpan

Toulouse, , France

Site Status

CHU Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2012/06

Identifier Type: -

Identifier Source: org_study_id

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