Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib
STIM 2
1 other identifier
interventional
220
1 country
32
Brief Summary
Background: Complete molecular remission under imatinib, therapeutic interruption possible for patients in complete remission proved in different trials. Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular remission during two following years. The objectives of this study are to determine the rate of patients without a molecular relapse and so the rate of molecular relapse, to determine and to seek for clinical and biological CML-related factors predictive for a molecular relapse after imatinib discontinuation. These objectives require to increase the number of study patients to be enrolled for accurate statistical considerations. It will allow to predict which patients have to be proposed for discontinuation without risk of molecular relapse and to select the patients who need to continue or reinforce the treatment to achieve a complete long term eradication of the disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2011
Longer than P75 for not_applicable
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2011
CompletedStudy Start
First participant enrolled
April 6, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2017
CompletedMarch 13, 2018
March 1, 2018
6.2 years
March 23, 2011
March 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of molecular relapse defined by the rate of patients having a significant increasing of BCR-ABL transcript.
Every months during two years
Secondary Outcomes (4)
Overall survival
after two years
Clinical and biological profile of patient with complete molecular remission persistence
after two years
Treatment costs according to days without imatinib.
after two years
Event-free survival
after two years
Study Arms (1)
Patients
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- years and older.
- Chronic myeloid leukaemia in chronic or accelerated phase under treatment with imatinib for at least 3 years.
- Complete molecular remission under treatment with imatinib for at least 2 years.
- HIV serology negative and absence of chronic hepatitis B or C.
- Molecular monitoring according to the international recommendations before the beginning of the study
- For the women old enough to procreate, method of effective contraception
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
You may not qualify if:
- Under 18 years old.
- Hospitalized patients without consent.
- Adults under law protection or without ability to assent.
- Previous or planned allogeneic stem cell transplantation.
- HIV serology positive or chronic hepatitis B or C.
- Interfering treatment (corticosteroids, immunosuppressors, chemotherapy, radiotherapy).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
University Hospital Angers
Angers, 49033, France
CH Annecy
Annecy, France
CHU Bensançon
Besançon, France
Institut Bergonié
Bordeaux, 33076, France
Hôpital Morvan
Brest, 29285, France
CHU Caen
Caen, France
Hôpitaux civils de Colmar
Colmar, 68000, France
CH Sud Francilien
Corbeil-Essonnes, France
Hôpital Henri-Mondor
Créteil, 94000, France
CHU Grenoble
Grenoble, 38043, France
Centre Hospitalier - La Roche sur Yon
La Roche-sur-Yon, 85025, France
Lille University hospital - Hôpital Claude Huriez
Lille, 59037, France
CHU Dupuytren
Limoges, France
Hôpital Edouard Herriot
Lyon, 69374, France
Institut Paoli Calmette
Marseille, 13273, France
CHU Hôtel-Dieu
Nantes, 44035, France
Centre Hospitalier de Nevers
Nevers, 58033, France
CHU de Nice - Hôpital Archet 1
Nice, 06202, France
Hôpital Saint Louis
Paris, 75475, France
Hôpital Necker-Enfants Malades
Paris, 75743, France
University Hospital Bordeaux, Hôpital du Haut Lévêque
Pessac, 33604, France
University Hospital Poitiers - Hôpital Jean Bernard
Poitiers, 86021, France
Hôpital Pontchaillou
Rennes, 35033, France
Centre Henri Becquerel
Rouen, France
CH Yves Le Foll
Saint-Brieuc, France
CHR La Réunion
Saint-Denis, 97405, France
CH Régional de l'ILE DE LA REUNION/ Groupe Hospitalier Sud
Saint-Pierre, France
Hôpital Purpan
Toulouse, 31059, France
CH Valence
Valence, France
C.H.U. Brabois
Vandœuvre-lès-Nancy, 54500, France
CH Bretagne Atlantique
Vannes, France
Centre Hospitalier de Versailles - Hôpital André Mignot
Versailles, 78157, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François-Xavier MAHON, Pr
University Hospital Bordeaux, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2011
First Posted
April 27, 2011
Study Start
April 6, 2011
Primary Completion
May 30, 2017
Study Completion
May 30, 2017
Last Updated
March 13, 2018
Record last verified: 2018-03