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
  Purpose

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.


Condition Intervention
Myeloid Leukemia, Chronic
Behavioral: Imatinib ending

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: June 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Imatinib treatment ending
Behavioral: Imatinib ending
Interruption of the treatment by Imatinib

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478985

Locations
France
University Hospital Angers
Angers Cedex 01, Angers, France, 49033
Hôpital Henri-Mondor
Creteil, Créteil, France, 94000
Hôpital Saint Louis
PARIS Cedex, Paris, France, 75475
University Hospital Bordeaux, Groupe Hospitalier Pellegrin
Bordeaux cedex, France, 33076
Institut Bergonié
BORDEAUX Cedex, France, 33076
Hôpital Morvan
Brest, France, 29285
CHU de Grenoble
Grenoble, France, 38043
Centre hospitalier-service de médecine interne Onco-Hématologique
La Roche sur Yon, France, 85025
Hôpital André Mignot
Le Chesnay Cedex, France, 78157
Hôpital Bicêtre, AP-HP
Le Kremlin-bicetre, France, 94275
Hôpital Claude Huriez
Lille, France, 59037
Hôpital Edouard Herriot
Lyon, France, 69374
Institut Paoli Calmet
Marseille Cedex 9, France, 13273
CHR de Metz-Thionville
Metz Cedex 01, France, 57038
University Hospital Hôtel-Dieu
Nantes, France, 44035
Centre Hospitalier de Nevers
Nevers, France, 58033
University Hospital Nice
Nice, France, 06202
Hôpital Necker-Enfants Malades
Paris, France, 75743
Haut Lévêque Hospital
Pessac, France, 33604
University Hospital Poitiers
Poitiers, France, 86021
University Hospital Strasbourg, Hôpital Civil
Strasbourg, France, 67000
University Hospital Toulouse, Purpan
Toulouse, France, 31059
University Hospital Brabois
Vandoeuvre Les Nancy, France, 54500
Centre Hospitalier Bretagne Atlantique
Vannes, France, 56 017
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: François-Xavier MAHON, MD University Hospital Bordeaux, France
  More Information

No publications provided by University Hospital, Bordeaux

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00478985     History of Changes
Other Study ID Numbers: CHUBX 2006/06
Study First Received: May 23, 2007
Last Updated: July 1, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Leukemia
Adult Chronic
Myeloid

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Disease Attributes
Pathologic Processes
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014