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

• ClinicalTrials.gov Identifier: NCT00478985
• Recruitment Status: Completed
• First Posted: May 25, 2007
• Last Update Posted: July 2, 2013
• Sponsor: University Hospital, Bordeaux
• Information provided by (Responsible Party): University Hospital, Bordeaux

Tracking Information

• First Submitted Date: May 23, 2007
• First Posted Date: May 25, 2007
• Last Update Posted Date: July 2, 2013
• Study Start Date: June 2007
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 1, 2011): Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts [ Time Frame: Every month during the first year and every two months during the second year ]

Original Primary Outcome Measures (submitted: May 24, 2007)

• Primary: 1. 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 [ Time Frame: two years ]
• 2. Haemogramme analyse every months during the first year and every two months during the second year [ Time Frame: two years ]
• 3. Clinical exam every three months during the first year and every four months during the second year [ Time Frame: two years ]

Current Secondary Outcome Measures (submitted: September 29, 2008)

• T lymphocytes differenciation and proliferation analyse / cytokines production analyse [ Time Frame: first visit, M2,M4,M6,M9,M12,M18,M24 ]
• T lymphocytes apoptosis analyse [ Time Frame: first visit ]
• Haemogramme analyse [ Time Frame: every months during two years ]
• Clinical exam [ Time Frame: every three months during the first year and every four months during the second year ]

Original Secondary Outcome Measures (submitted: May 24, 2007)

• 1. T lymphocytes differenciation and proliferation analyse / cytokines production analyse
• 2. T lymphocytes apoptosis analyse

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Myeloid Leukemia, Chronic

Intervention

Behavioral: Imatinib ending

Interruption of the treatment by Imatinib

Study Arms

Experimental: 1

Imatinib treatment ending

Intervention: Behavioral: Imatinib ending

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 1, 2013): 100
• Original Estimated Enrollment (submitted: May 24, 2007): 50
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00478985
• Other Study ID Numbers: CHUBX 2006/06
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Bordeaux
• Original Responsible Party: Not Provided
• Current Study Sponsor: University Hospital, Bordeaux
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: François-Xavier MAHON, MD; University Hospital Bordeaux, France

• PRS Account: University Hospital, Bordeaux
• Verification Date: July 2013