Participant flow

Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients · Source last updated 2026-08-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants who received nilotinib during the consolidation phase and, if eligible, entered the treatment-free remission phase following nilotinib discontinuation.

   id

   FG000

   title

   Nilotinib Treatment and Treatment-Free Remission Cohort

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Patient/guardian decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         215

      comment

      NTCS Phase: Patients who satisfied all the inclusion and none of the exclusion criteria were to be enrolled into the consolidation phase where the patients were treated with nilotinib with the same dose as prior to study entry. Duration of the consolidation phase was 52 weeks or until a patient experienced unacceptable toxicity, disease progression, death, loss to follow-up, and/or treatment was discontinued at the discretion of the Investigator or due to withdrawal of consent.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         203

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         12

      type

      NOT COMPLETED

   title

   Nilotinib Treatment Consolidation Phase

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         18

      type

      Patient/guardian decision

   2. reasons

      1. group Id

         FG000

         num Subjects

         98

      type

      Lack of Efficacy

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         190

      comment

      TFR Phase: The duration of the TFR phase was up to 528 weeks after the last patient entered the TFR phase. Patients stopped taking nilotinib on the day they entered this phase.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         65

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         125

      type

      NOT COMPLETED

   title

   Nilotinib Treatment-free Remission Phase

pre Assignment Details

Informed consent was obtained from each participant in writing before screening and before any study specific procedure was performed.

recruitment Details

Recruitment for the study comprised a total of 215 participants, who were enrolled at 132 clinical sites distributed across 19 different countries..

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Preserved source evidence · Not medical advice