Participant flow

A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL · Source last updated 2019-10-01

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

groups

1. description

   Vitamin B12 and folic acid will be taken concurrently with pralatrexate pralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle. Vitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator.

   id

   FG000

   title

   Pralatrexate

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         36

      type

      Progression of Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         11

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      type

      Other

   4. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Conditions interfere with participation

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      3-week lapse between pralatrexate doses

   8. reasons

      1. group Id

         FG000

         num Subjects

         8

      type

      Patients in treatment less than 24 month

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         71

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         71

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

In the protocol, 85 patients are planned to enroll. However, 71 patients are treated in the real situation.

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

Preserved source evidence · Not medical advice