Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
STIM-FU
1 other identifier
observational
97
1 country
19
Brief 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2013
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2013
CompletedFirst Submitted
Initial submission to the registry
August 17, 2016
CompletedFirst Posted
Study publicly available on registry
September 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedJune 19, 2020
June 1, 2020
6 years
August 17, 2016
June 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Evaluation of rate of molecular relapse after imatinib discontinuation
up to five years
Evaluation of duration of deep molecular response after stopping imatinib
up to five years
Status dead or alive for each patient
up to five years
Study Arms (1)
Imatinib treatment ending
Interruption of the treatment by Imatinib
Interventions
Eligibility Criteria
Patients included in the STIM1 protocol with persistence of the Complete Molecular Remission after Stopping Imatinib Chronic Myeloid Leukemia
You may qualify if:
- The patients should have been included in the STIM1 Study CHUBX 2006/06 (NCT00478985)
You may not qualify if:
- The patients not included or discharged prematurely from the STIM1 Study can not participate to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
CHU d'Angers
Angers, 49033, France
Institut Bergonié
Bordeaux, 33076, France
CHU de Bordeaux - Haut-Lévêque
Bordeaux, 33604, France
Hôpital Morvan
Brest, 29285, France
Hôpital Henri-Mondor
Créteil, 94000, France
Pôle de cancérologie
Grenoble, 38043, France
Centre Hospitalier de La Roche Sur Yon
La Roche-sur-Yon, 85025, France
Centre Hospitalier de Versailles
Le Chesnay, 78157, France
Hôpital Claude Huriez
Lille, 59037, France
Hôpital Edouard Herriot
Lyon, 69374, France
Institut Paoli Calmette
Marseille, 13273, France
CHU Hôtel-Dieu
Nantes, 44035, France
CHU de Nice
Nice, 06202, France
Hôpital Saint Louis
Paris, 75475, France
Hôpital Necker-Enfants Malades
Paris, 75743, France
CHU de Poitiers
Poitiers, 86021, France
Hôpital Civil
Strasbourg, 67000, France
Hôpital Purpan
Toulouse, 31059, France
CHU Brabois
Vandœuvre-lès-Nancy, 54500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2016
First Posted
September 12, 2016
Study Start
April 3, 2013
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
June 19, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share