Participant flow

A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) · Source last updated 2025-03-07

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

groups

1. description

   Duvelisib was administered orally (PO) twice daily (BID) at a starting dose of 25 milligrams (mg), with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.

   id

   FG000

   title

   Dose Optimization Phase: Cohort 1

2. description

   Duvelisib 75 mg PO BID was administered in 28-day cycles.

   id

   FG001

   title

   Dose Optimization Phase: Cohort 2

3. description

   Duvelisib PO BID at a starting dose of 75 mg was administered for the first 2 cycles (28-day cycles), followed by a mandatory reduction to 25 mg BID thereafter for those participants with complete response (CR), partial response (PR) or stable disease (SD), in 28-day cycles (dose determined in Optimization Phase).

   id

   FG002

   title

   Expansion Phase

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Closure Of The Study By The Sponsor

   3. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         0

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         0

      comment

      Safety Analysis Set; Modified Intent-to-treat (mITT)

      type

      Received at Least 1 Dose of Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Dose Optimization Phase

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         4

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         39

      type

      Closure Of The Study By The Sponsor

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         78

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Progressive Disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Adverse Event

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. comment

         Participants enrolled for Expansion Phase only.

         group Id

         FG002

         num Subjects

         123

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         123

      comment

      Safety Analysis Set; Modified Intent-to-treat (mITT)

      type

      Received at Least 1 Dose of Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         123

      type

      NOT COMPLETED

   title

   Expansion Phase

recruitment Details

Regardless of study phase, all participants underwent screening assessments up to 30 days before the first study drug dose.

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Preserved source evidence · Not medical advice