CompletedPhase 2

Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients

United States215 participantsStarted 2013-03-19

Plain-language summary

The main purpose of the study was to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment

Who can participate

Age range18 Years – 100 Years

SexALL

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Exclusion criteria

✕. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception.
✕. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
✕. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.

What they're measuring

Percentage of Patients Who Are in MMR (Major Molecular Response) at 48 Weeks After Starting the Treatment-free Remission (TFR) Phase

Timeframe: 48 weeks

Trial details

NCT IDNCT01784068

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-05-31

Results submitted2020-12-18

View on ClinicalTrials.gov More Chronic Myelogenous Leukemia trials