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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02896829
Other study ID # CHUBX 2012/06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 3, 2013
Est. completion date April 2019

Study information

Verified date June 2020
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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?


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Interruption of the treatment by Imatinib


Locations

Country Name City State
France CHU d'Angers Angers
France CHU de Bordeaux - Haut-Lévêque Bordeaux
France Institut Bergonié Bordeaux
France Hôpital Morvan Brest
France Hôpital Henri-Mondor Creteil
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 Necker-Enfants Malades Paris
France Hôpital Saint Louis Paris
France CHU de Poitiers Poitiers
France Hôpital Civil Strasbourg
France Hôpital Purpan Toulouse
France CHU Brabois Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the molecular status (BCR-ABL1 quantification by RT-qPCR) in the STIM1 population who stopped or restart a treatment by tyrosine kinase inhibitor (TKI) up to five years
Secondary Evaluation of rate of molecular relapse after imatinib discontinuation up to five years
Secondary Evaluation of duration of deep molecular response after stopping imatinib up to five years
Secondary Status dead or alive for each patient up to five years
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