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

July 1, 2013 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Imatinib treatment ending
Behavioral: Imatinib ending
Interruption of the treatment by Imatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Every month during the first year and every two months during the second year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 23, 2007

First Submitted That Met QC Criteria

May 24, 2007

First Posted (Estimate)

May 25, 2007

Study Record Updates

Last Update Posted (Estimate)

July 2, 2013

Last Update Submitted That Met QC Criteria

July 1, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2006/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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