Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia

Myeloid Leukemia, Chronic Clinical Trial

— STIM  

Official title:

Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478985
• Other study ID #: CHUBX 2006/06
• Status: Completed
• Phase: N/A
• First received: May 23, 2007
• Last updated: July 1, 2013
• Start date: June 2007
• Est. completion date: December 2011

Study information

• Verified date: July 2013
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 a):

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Myeloid Leukemia, Chronic

Intervention

Behavioral:
• Imatinib ending
Interruption of the treatment by Imatinib

Locations

Country	Name	City	State
France	University Hospital Angers	Angers Cedex 01	Angers
France	Institut Bergonié	BORDEAUX Cedex
France	University Hospital Bordeaux, Groupe Hospitalier Pellegrin	Bordeaux cedex
France	Hôpital Morvan	Brest
France	Hôpital Henri-Mondor	Creteil	Créteil
France	CHU de Grenoble	Grenoble
France	Centre hospitalier-service de médecine interne Onco-Hématologique	La Roche sur Yon
France	Hôpital André Mignot	Le Chesnay Cedex
France	Hôpital Bicêtre, AP-HP	Le Kremlin-bicetre
France	Hôpital Claude Huriez	Lille
France	Hôpital Edouard Herriot	Lyon
France	Institut Paoli Calmet	Marseille Cedex 9
France	CHR de Metz-Thionville	Metz Cedex 01
France	University Hospital Hôtel-Dieu	Nantes
France	Centre Hospitalier de Nevers	Nevers
France	University Hospital Nice	Nice
France	Hôpital Necker-Enfants Malades	Paris
France	Hôpital Saint Louis	PARIS Cedex	Paris
France	Haut Lévêque Hospital	Pessac
France	University Hospital Poitiers	Poitiers
France	University Hospital Strasbourg, Hôpital Civil	Strasbourg
France	University Hospital Toulouse, Purpan	Toulouse
France	University Hospital Brabois	Vandoeuvre Les Nancy
France	Centre Hospitalier Bretagne Atlantique	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts		Every month during the first year and every two months during the second year	No
Secondary	T lymphocytes differenciation and proliferation analyse / cytokines production analyse		first visit, M2,M4,M6,M9,M12,M18,M24	No
Secondary	T lymphocytes apoptosis analyse		first visit	No
Secondary	Haemogramme analyse		every months during two years	No
Secondary	Clinical exam		every three months during the first year and every four months during the second year	No