Participant flow

A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma · Source last updated 2025-12-23

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

groups

1. description

   Participants with relapsed or refractory (r/r) B-cell indolent non-Hodgkin lymphoma (iNHL) subtype of follicular lymphoma (FL) received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (IV) and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.

   id

   FG000

   title

   Axicabtagene Ciloleucel (Follicular Lymphoma)

2. description

   Participants with r/r B-cell iNHL subtype of marginal zone lymphoma (MZL) received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

   id

   FG001

   title

   Axicabtagene Ciloleucel (Marginal Zone Lymphoma)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         61

      2. group Id

         FG001

         num Subjects

         15

      type

      Rollover to Longterm Follow-up Study Criteria

   2. reasons

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         8

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         3

      type

      Subject Withdrawal of Consent from Further Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Reason Not Specified

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Investigator Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         127

      2. group Id

         FG001

         num Subjects

         31

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         127

      2. group Id

         FG001

         num Subjects

         31

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

189 participants were screened. A total of 159 participants were enrolled. However, one participant discontinued the study as the participant did not meet study condition eligibility criteria (was diagnosed with diffuse large B-cell lymphoma (DLBCL)). So, 158 participants were considered in the Full Analysis Set (FAS = all enrolled participants).

recruitment Details

Participants were enrolled at study sites in the United States and France.

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Preserved source evidence · Not medical advice