Participant flow

The Addition of Temozolomide to Conditioning for Autologous Transplantation in Relapsed & Refractory CNS Lymphoma · Source last updated 2018-11-20

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

groups

1. description

   Temozolomide: The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m\^2 (cumulative total dose of 1250 mg/m\^2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.

   id

   FG000

   title

   DRBEAT Regimen

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         11

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         5

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice