Participant flow

Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma · Source last updated 2018-07-31

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

groups

1. description

   Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).

   id

   FG000

   title

   Alisertib

2. description

   Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).

   id

   FG001

   title

   Pralatrexate, or Romidepsin, or Gemcitabine

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         65

      2. group Id

         FG001

         num Subjects

         53

      type

      Progressive Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         37

      2. group Id

         FG001

         num Subjects

         23

      type

      Unsatisfactory Therapeutic Response

   3. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         22

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         13

      type

      Withdrawal by Participant

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         9

      type

      Hematopoietic Stem Cell Transplant

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         5

      type

      Other Reason

   7. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         2

      type

      Study Terminated by Sponsor

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         6

      type

      Did not Receive Study Drug

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         138

      2. group Id

         FG001

         num Subjects

         133

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         137

      2. group Id

         FG001

         num Subjects

         127

      type

      Safety Population: Received Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         138

      2. group Id

         FG001

         num Subjects

         133

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with a diagnosis of Relapsed or Refractory Peripheral T-Cell Lymphoma were randomized 1:1 to either alisertib or comparator (investigator's choice of pralatrexate, romidepsin \[USA only\], or gemcitabine).

recruitment Details

Participants took part in the study at 105 investigative sites in the United States including Puerto Rico, Canada, European Union, Russian Federation, Turkey, Israel, Australia, New Zealand and Latin America from 11 June 2012 to the end of study on 18 December 2017.

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

Preserved source evidence · Not medical advice