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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

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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-004048-31-FR
Enrollment
70
Registered
2021-01-15
Start date
2014-04-07
Completion date
Unknown
Last updated
2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic myeloid leukemia (CML)

Interventions

Trade Name: Nilotinib, Tasigna®, 150 mg Product Name: Tasigna Product Code: AMN107 Pharmaceutical Form: Capsule Trade Name: Nilotinib, Tasigna®, 200 mg Product Name: Tasigna Product Code: AMN107 Phar

Sponsors

CHU de Bordeaux
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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):—

Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026