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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00478985
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myeloid Leukemia, Chronic Behavioral: Imatinib ending Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)
Study Start Date : June 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Imatinib treatment ending
 Behavioral: Imatinib ending
Interruption of the treatment by Imatinib


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478985


Locations
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Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: François-Xavier MAHON, MD University Hospital Bordeaux, France
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00478985    
Other Study ID Numbers: CHUBX 2006/06
First Posted: May 25, 2007    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013
Keywords provided by University Hospital, Bordeaux:
Leukemia
Adult Chronic
Myeloid
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Chronic Disease
 Disease Attributes
Pathologic Processes
Imatinib Mesylate
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents