Participant flow

Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL) · Source last updated 2026-05-06

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

groups

1. description

   Romidepsin 10mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.

   id

   FG000

   title

   Phase I Dose Level 4:Romidepsin 10mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15

2. description

   Romidepsin 14mg/m² IV on days 1, 8: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.

   id

   FG001

   title

   Phase I Dose Level 5: Romidepsin 14mg/m² IV on Days 1, 8; Ixazomib 4 mg PO on Days 1, 8, 15

3. description

   Romidepsin 14mg/m² IV on days 1, 8, 15: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.

   id

   FG002

   title

   Phase I Dose Level 6: Romidepsin 14mg/m² IV on Days 1, 8, 15; Ixazomib 4 mg PO on Days 1, 8, 15

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         0

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         1

      type

      Study Terminated

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Refused to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         1

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         1

      type

      DLT Period (First 28 Days of Treatment)

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      comment

      Total duration of followup was planned to be either 1 year from time of documented progressive disease or a total duration of 2 years after initiation of treatment, whichever was sooner.

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

This study was terminated prior to opening the Phase II portion of the trial.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice