Last reviewed · How we verify

NCT01343173: STIM 2

Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib

Completed NA Last updated 13 March 2018
What this trial tests

NA trial testing Imatinib stop in Chronic Myeloid Leukaemia in 220 participants. Completed in 30 May 2017.

Timeline
6 April 2011
Primary endpoint
30 May 2017
30 May 2017

Quick facts

Lead sponsorUniversity Hospital, Bordeaux
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment220
Start date6 April 2011
Primary completion30 May 2017
Estimated completion30 May 2017
Sites32 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Bordeaux

Who can join

18 and older, any sex, with Chronic Myeloid Leukaemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Complete molecular remission under imatinib, therapeutic interruption possible for patients in complete remission proved in different trials. Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular remission during two following years. The objectives of this study are to determine the rate of patients without a molecular relapse and so the rate of molecular relapse, to determine and to seek for clinical and biological CML-related factors predictive for a molecular relapse after imatinib discontinuation. These objectives require to increase the number of study patients to be enrolled for accurate statistical considerations. It will allow to predict which patients have to be proposed for discontinuation without risk of molecular relapse and to select the patients who need to continue or reinforce the treatment to achieve a complete long term eradication of the disease.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Killer immunoglobulin-like receptor genotypes and chronic myeloid leukemia outcomes after imatinib cessation for treatment-free remission.
    Dumas PY, Bérard E, Bréal C, Dulucq S, et al · · 2019 · cited 12× · PMID 31287239 · DOI 10.1002/cam4.2371

Verify or expand the search:

Other recruiting trials for Chronic Myeloid Leukaemia

Currently open trials in the same condition.

Other University Hospital, Bordeaux trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01343173.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing