Clinical trial NCT00478985: Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
Official title: Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myeloid Leukemia, Chronic
Keywords: Leukemia
Adult Chronic
Myeloid
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2007-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for bcr-abl transcripts). The second purpose is to determine clinicals and biologicals factors associated with the persistent complete molecular remission.

Detailed description: Principal Objective : To evaluate the complete molecular remission persistence after stopping imatinib during six months as measured by RT-PCR negative for bcr-abl transcripts in patients with Chronic Myeloid Leukemia .

Secondary Objective :

* To determine clinicals factors associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukemia.
* To determine the biologics factors (immunologic and molecular) associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukaemia.
* To determine the molecular relapse level after more than six month of persistent complete molecular remission without imatinib.
* To determine the complete molecular remission length.
* To evaluate medical and economical impact of stopping imatinib treatment.

Study design : multicentric trial

Eligibility criteria: Inclusion Criteria:

* Patients must have reached their 18th birthday
* Women of childbearing potential must agree to use effective methods of contraception
* Patients must be affiliated to a social security regime
* Patients must have received imatinib therapy for at least 36 months.
* Patients must be in complete molecular remission during at least two consecutive years with at least five RT-PCR negative measures for bcr-abl transcripts.
* Patients must be HIV, HCV and HBV negatives
* Patients who have molecular follow-up realized in accordance with international recommendations
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

Exclusion Criteria:

* Patients who are protected by the law. Patients who are unable to give their consent to participate to the study.
* Patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping imatinib. Patients who have pathologies or treatments which able to interfere with immunologic study (excepted IFN α):

Corticosteroids or other immuno suppressors Other concomitant malign pathology treated by chemotherapy or radiotherapy Previous or programmed Haematopoietic Stem Cell allogreffe

Primary outcomes:
measure: Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts
timeFrame: Every month during the first year and every two months during the second year
Secondary outcomes:
measure: T lymphocytes differenciation and proliferation analyse / cytokines production analyse
timeFrame: first visit, M2,M4,M6,M9,M12,M18,M24
measure: T lymphocytes apoptosis analyse
timeFrame: first visit
measure: Haemogramme analyse
timeFrame: every months during two years
measure: Clinical exam
timeFrame: every three months during the first year and every four months during the second year
Other outcomes:
Locations:
city: Angers Cedex 01
country: France
facility: University Hospital Angers
state: Angers
city: Creteil
country: France
facility: Hôpital Henri-Mondor
state: Créteil
city: PARIS Cedex
country: France
facility: Hôpital Saint Louis
state: Paris
city: BORDEAUX Cedex
country: France
facility: Institut Bergonié
city: Bordeaux cedex
country: France
facility: University Hospital Bordeaux, Groupe Hospitalier Pellegrin
city: Brest
country: France
facility: Hôpital Morvan
city: Grenoble
country: France
facility: CHU de Grenoble
city: La Roche sur Yon
country: France
facility: Centre hospitalier-service de médecine interne Onco-Hématologique
city: Le Chesnay Cedex
country: France
facility: Hôpital André Mignot
city: Le Kremlin-bicetre
country: France
facility: Hôpital Bicêtre, AP-HP
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Marseille Cedex 9
country: France
facility: Institut Paoli Calmet
city: Metz Cedex 01
country: France
facility: CHR de Metz-Thionville
city: Nantes
country: France
facility: University Hospital Hôtel-Dieu
city: Nevers
country: France
facility: Centre Hospitalier de Nevers
city: Nice
country: France
facility: University Hospital Nice
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
city: Pessac
country: France
facility: Haut Lévêque Hospital
city: Poitiers
country: France
facility: University Hospital Poitiers
city: Strasbourg
country: France
facility: University Hospital Strasbourg, Hôpital Civil
city: Toulouse
country: France
facility: University Hospital Toulouse, Purpan
city: Vandoeuvre Les Nancy
country: France
facility: University Hospital Brabois
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
Study officials:
affiliation: University Hospital Bordeaux, France
name: François-Xavier MAHON, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rea D, Henry G, Khaznadar Z, Etienne G, Guilhot F, Nicolini F, Guilhot J, Rousselot P, Huguet F, Legros L, Gardembas M, Dubruille V, Guerci-Bresler A, Charbonnier A, Maloisel F, Ianotto JC, Villemagne B, Mahon FX, Moins-Teisserenc H, Dulphy N, Toubert A. Natural killer-cell counts are associated with molecular relapse-free survival after imatinib discontinuation in chronic myeloid leukemia: the IMMUNOSTIM study. Haematologica. 2017 Aug;102(8):1368-1377. doi: 10.3324/haematol.2017.165001. Epub 2017 May 18.
citation: Mahon FX, Rea D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Francais des Leucemies Myeloides Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19.