Multicenter single-arm pilot study evaluating efficacy of nilotinib in CML patients with molecular relapse after Glivec discontinuation within the context of the STIM trials (STIM and STIM2), Nilo Post-STIM - Nilo Post-STIM
Phase 1
- Conditions
- Chronic myeloid leukemia (CML)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004048-31-FR
- Lead Sponsor
- CHU de Bordeaux
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess if Nilotinib can rescue STIM patients in molecular relapse after IM discontinuation and to provide estimation about duration of CMR after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years of stable CMR with nilotinib.;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method