Participant flow

Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies · Source last updated 2017-06-06

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

groups

1. description

   * Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.

   id

   FG000

   title

   Subcutaneous (SC) Treatment Plan - Donor

2. description

   * Conditioning Regimen * Cyclophosphamide 60mg/kg/day on Days -3 and -2 * TBI 550cGy on Day -1 * GVHD prophylaxis \*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100 * PBSC transplant on Day 0

   id

   FG001

   title

   Recipients

3. description

   * Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis * Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.

   id

   FG002

   title

   Intravenous (IV) Treatment Plan - Donor

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Determined to be not ineligible

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         46

      3. group Id

         FG002

         num Subjects

         21

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         45

      3. group Id

         FG002

         num Subjects

         20

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

The study was opened to participant enrollment on 05/14/2004 and closed to participant enrollment on 01/26/2009.

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

Preserved source evidence · Not medical advice