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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00478985
First received: May 23, 2007
Last updated: July 1, 2013
Last verified: July 2013

May 23, 2007
July 1, 2013
June 2007
December 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT00478985 on ClinicalTrials.gov Archive Site
  • T lymphocytes differenciation and proliferation analyse / cytokines production analyse [ Time Frame: first visit, M2,M4,M6,M9,M12,M18,M24 ] [ Designated as safety issue: No ]
  • T lymphocytes apoptosis analyse [ Time Frame: first visit ] [ Designated as safety issue: No ]
  • Haemogramme analyse [ Time Frame: every months during two years ] [ Designated as safety issue: No ]
  • Clinical exam [ Time Frame: every three months during the first year and every four months during the second year ] [ Designated as safety issue: No ]
  • 1. T lymphocytes differenciation and proliferation analyse / cytokines production analyse
  • 2. T lymphocytes apoptosis analyse
Not Provided
Not Provided
 
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)

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.

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

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myeloid Leukemia, Chronic
Behavioral: Imatinib ending
Interruption of the treatment by Imatinib
Experimental: 1
Imatinib treatment ending
Intervention: Behavioral: Imatinib ending
Mahon FX, Réa D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Français des Leucémies Myéloïdes 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. Epub 2010 Oct 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2011
December 2011   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00478985
CHUBX 2006/06
Yes
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: François-Xavier MAHON, MD University Hospital Bordeaux, France
University Hospital, Bordeaux
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP