Trials / Completed
CompletedNCT00478985
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- University Hospital, Bordeaux · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Imatinib ending | Interruption of the treatment by Imatinib |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2011-12-01
- Completion
- 2011-12-01
- First posted
- 2007-05-25
- Last updated
- 2013-07-02
Locations
24 sites across 1 country: France
Source: ClinicalTrials.gov record NCT00478985. Inclusion in this directory is not an endorsement.