Participant flow

Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients · Source last updated 2014-03-13

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

groups

1. description

   Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

   id

   FG000

   title

   G-CSF Plus Plerixafor

2. description

   Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

   id

   FG001

   title

   G-CSF Plus Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         52

      type

      Entered Rescue Procedure

   2. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         12

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      type

      Elective Withdrawal

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Adverse Event

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         7

      type

      Other

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         5

      type

      Failed mobilization

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Noncompliance

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         150

      2. group Id

         FG001

         num Subjects

         148

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         112

      2. group Id

         FG001

         num Subjects

         68

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         38

      2. group Id

         FG001

         num Subjects

         80

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Participants with non-Hodgkin's lymphoma (NHL) eligible for autologous hematopoietic stem cell transplant were recruited from 31 centers in the U.S. and 1 in Canada. The first participant was randomized on 18 January 2005 and the last participant's last study visit occurred on 20 December 2007. A total of 298 participants were randomized.

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Preserved source evidence · Not medical advice