Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital, Bordeaux
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00478985
First received: May 23, 2007
Last updated: June 13, 2012
Last verified: June 2012
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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 ]
| Estimated Enrollment: | 70 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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
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: | June 13, 2012 |
| 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 May 19, 2013