Participant flow

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP · Source last updated 2026-08-28

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

groups

1. description

   Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.

   id

   FG000

   title

   Asciminib (Imatinib Stratum)

2. description

   Patients took ascimimib 80 mg QD under fasting conditions on ongoing basis.

   id

   FG001

   title

   Asciminib (2nd Generation TKI Stratum)

3. description

   Patients took on ongoing basis the Investigator selected TKI (imatinib)

   id

   FG002

   title

   Investigator Selected TKI (Imatinib Stratum)

4. description

   Patients took on ongoing basis the 2G investigator selected TKIs (nilotinib, or dasatinib, or bosutinib)

   id

   FG003

   title

   Investigator Selected TKI (2nd Generation TKI Stratum

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         21

      4. group Id

         FG003

         num Subjects

         10

      type

      Unsatisfactory therapeutic effect

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         11

      4. group Id

         FG003

         num Subjects

         10

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         1

      type

      Progressive disease

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      type

      Protocol Deviation

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      type

      Subject Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      type

      Pregnancy

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         1

      type

      Participants not treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         101

      2. group Id

         FG001

         num Subjects

         100

      3. group Id

         FG002

         num Subjects

         102

      4. group Id

         FG003

         num Subjects

         102

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         1

      type

      Participants Not Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         100

      2. group Id

         FG001

         num Subjects

         100

      3. group Id

         FG002

         num Subjects

         100

      4. group Id

         FG003

         num Subjects

         101

      type

      Treated

   4. achievements

      1. group Id

         FG000

         num Subjects

         85

      2. group Id

         FG001

         num Subjects

         88

      3. group Id

         FG002

         num Subjects

         63

      4. group Id

         FG003

         num Subjects

         77

      comment

      Participants for whom treatment is ongoing at the time of Data Cut-Off (DOC)

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         12

      3. group Id

         FG002

         num Subjects

         39

      4. group Id

         FG003

         num Subjects

         25

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Prior to randomization, the Investigator, in consultation with the participant, considering current treatment paradigm and participant characteristics - and comorbidities, made a selection of imatinib or 2G TKI (nilotinib, dasatinib, or bosutinib) to be used if the participant is randomized to the comparator arm. The enrolment into the strata of imatinib versus 2G TKI was managed by IRT to be approximately 50% versus 50%.

recruitment Details

All trial participants randomized in a 1:1 ratio between asciminib and investigator selected TKI (imatinib 400 mg QD, nilotinib 300 mg BD, dasatinib 100 mg QD or bosutinib 400 mg QD).

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Preserved source evidence · Not medical advice