Participant flow

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma · Source last updated 2025-12-01

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

groups

1. description

   Participants received cyclophosphamide 500 mg/m\^2/day intravenous (IV) infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-cluster of differentiation antigen (CD) 19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.

   id

   FG000

   title

   Axicabtagene Ciloleucel

2. description

   Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours continuous infusion (CI) on Day 2 + mesna, carboplatin area under the curve (AUC) 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.

   id

   FG001

   title

   Standard of Care Therapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         84

      2. group Id

         FG001

         num Subjects

         91

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         80

      2. group Id

         FG001

         num Subjects

         0

      type

      Rollover to Long-term Follow-up Study Criteria

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         13

      type

      Subject Withdrawal of Consent from Further Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         5

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Reason Not Specified

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Investigator Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         180

      2. group Id

         FG001

         num Subjects

         179

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         67

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         178

      2. group Id

         FG001

         num Subjects

         112

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

437 participants were screened.

recruitment Details

Participants were enrolled at study sites in North America, Middle East, Europe, and Australia.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice