search
Back to results

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

Primary Purpose

Myeloid Leukemia, Chronic

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Imatinib ending
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myeloid Leukemia, Chronic focused on measuring Leukemia, Adult Chronic, Myeloid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Angers
  • Hôpital Henri-Mondor
  • Hôpital Saint Louis
  • Institut Bergonié
  • University Hospital Bordeaux, Groupe Hospitalier Pellegrin
  • Hôpital Morvan
  • CHU de Grenoble
  • Centre hospitalier-service de médecine interne Onco-Hématologique
  • Hôpital André Mignot
  • Hôpital Bicêtre, AP-HP
  • Hôpital Claude Huriez
  • Hôpital Edouard Herriot
  • Institut Paoli Calmet
  • CHR de Metz-Thionville
  • University Hospital Hôtel-Dieu
  • Centre Hospitalier de Nevers
  • University Hospital Nice
  • Hôpital Necker-Enfants Malades
  • Haut Lévêque Hospital
  • University Hospital Poitiers
  • University Hospital Strasbourg, Hôpital Civil
  • University Hospital Toulouse, Purpan
  • University Hospital Brabois
  • Centre Hospitalier Bretagne Atlantique

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Imatinib treatment ending

Outcomes

Primary Outcome Measures

Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts

Secondary Outcome Measures

T lymphocytes differenciation and proliferation analyse / cytokines production analyse
T lymphocytes apoptosis analyse
Haemogramme analyse
Clinical exam

Full Information

First Posted
May 23, 2007
Last Updated
July 1, 2013
Sponsor
University Hospital, Bordeaux
search

1. Study Identification

Unique Protocol Identification Number
NCT00478985
Brief Title
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
Acronym
STIM
Official Title
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloid Leukemia, Chronic
Keywords
Leukemia, Adult Chronic, Myeloid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Imatinib treatment ending
Intervention Type
Behavioral
Intervention Name(s)
Imatinib ending
Intervention Description
Interruption of the treatment by Imatinib
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
T lymphocytes differenciation and proliferation analyse / cytokines production analyse
Time Frame
first visit, M2,M4,M6,M9,M12,M18,M24
Title
T lymphocytes apoptosis analyse
Time Frame
first visit
Title
Haemogramme analyse
Time Frame
every months during two years
Title
Clinical exam
Time Frame
every three months during the first year and every four months during the second year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François-Xavier MAHON, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Angers
City
Angers Cedex 01
State/Province
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Hôpital Henri-Mondor
City
Creteil
State/Province
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Hôpital Saint Louis
City
PARIS Cedex
State/Province
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Institut Bergonié
City
BORDEAUX Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
University Hospital Bordeaux, Groupe Hospitalier Pellegrin
City
Bordeaux cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Morvan
City
Brest
ZIP/Postal Code
29285
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre hospitalier-service de médecine interne Onco-Hématologique
City
La Roche sur Yon
ZIP/Postal Code
85025
Country
France
Facility Name
Hôpital André Mignot
City
Le Chesnay Cedex
ZIP/Postal Code
78157
Country
France
Facility Name
Hôpital Bicêtre, AP-HP
City
Le Kremlin-bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69374
Country
France
Facility Name
Institut Paoli Calmet
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
CHR de Metz-Thionville
City
Metz Cedex 01
ZIP/Postal Code
57038
Country
France
Facility Name
University Hospital Hôtel-Dieu
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
Centre Hospitalier de Nevers
City
Nevers
ZIP/Postal Code
58033
Country
France
Facility Name
University Hospital Nice
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Haut Lévêque Hospital
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
University Hospital Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
University Hospital Strasbourg, Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
University Hospital Toulouse, Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
University Hospital Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Centre Hospitalier Bretagne Atlantique
City
Vannes
ZIP/Postal Code
56 017
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28522576
Citation
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.
Results Reference
derived
PubMed Identifier
20965785
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs