Chronic Myeloid Leukemia Clinical Trial
— STIM-FUOfficial title:
Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
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 |
Verified date | June 2020 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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?
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
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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