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CompletedNCT00478985STIMUpdated Jul 2, 2013

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

An interventional study of Imatinib ending in Myeloid Leukemia, Chronic, sponsored by University Hospital, Bordeaux. Completed at 24 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-02.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Myeloid Leukemia, Chronic

Keywords

  • Leukemia
  • Adult Chronic
  • Myeloid
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 100 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    1

    Imatinib treatment ending

    Behavioral: Imatinib ending

Interventions

  • BehavioralImatinib ending

    Interruption of the treatment by Imatinib

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. T lymphocytes differenciation and proliferation analyse / cytokines production analyse

    Time frame: first visit, M2,M4,M6,M9,M12,M18,M24

  2. T lymphocytes apoptosis analyse

    Time frame: first visit

  3. Haemogramme analyse

    Time frame: every months during two years

  4. Clinical exam

    Time frame: every three months during the first year and every four months during the second year

07

Study locations

24 sites
  • University Hospital Angers
    Angers Cedex 01, Angers 49033, France
  • Hôpital Henri-Mondor
    Creteil, Créteil 94000, France
  • Hôpital Saint Louis
    PARIS Cedex, Paris 75475, France
  • Institut Bergonié
    BORDEAUX Cedex, 33076, France
  • University Hospital Bordeaux, Groupe Hospitalier Pellegrin
    Bordeaux cedex, 33076, France
  • Hôpital Morvan
    Brest, 29285, France
  • CHU de Grenoble
    Grenoble, 38043, France
  • Centre hospitalier-service de médecine interne Onco-Hématologique
    La Roche sur Yon, 85025, France
  • Hôpital André Mignot
    Le Chesnay Cedex, 78157, France
  • Hôpital Bicêtre, AP-HP
    Le Kremlin-bicetre, 94275, France
  • Hôpital Claude Huriez
    Lille, 59037, France
  • Hôpital Edouard Herriot
    Lyon, 69374, France
  • Institut Paoli Calmet
    Marseille Cedex 9, 13273, France
  • CHR de Metz-Thionville
    Metz Cedex 01, 57038, France
  • University Hospital Hôtel-Dieu
    Nantes, 44035, France
  • Centre Hospitalier de Nevers
    Nevers, 58033, France
  • University Hospital Nice
    Nice, 06202, France
  • Hôpital Necker-Enfants Malades
    Paris, 75743, France
  • Haut Lévêque Hospital
    Pessac, 33604, France
  • University Hospital Poitiers
    Poitiers, 86021, France
  • University Hospital Strasbourg, Hôpital Civil
    Strasbourg, 67000, France
  • University Hospital Toulouse, Purpan
    Toulouse, 31059, France
  • University Hospital Brabois
    Vandoeuvre Les Nancy, 54500, France
  • Centre Hospitalier Bretagne Atlantique
    Vannes, 56 017, France
08

References and documents

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. PubMed 28522576 ↗
  • 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. PubMed 20965785 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00478985
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
May 25, 2007
Start date
Jun 2007
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Jul 2, 2013

Study contacts

François-Xavier MAHON, MD
principal investigator · University Hospital Bordeaux, France

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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