Skip to content
← Full study record

NCT03575351 · OUTCOME

Hospital Resource Utilization (HRU) Results

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas · Source last updated 2025-08-03

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 36 months

What was measured

Hospital resource utilization (HRU) results including hospitalized, reasons for hospitalizations, and admitted to intensive care unit (ICU)

Analysis population: All participants treated in any study medication

Groups in this outcome

Standard of Care Arm

3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks

Liso-cel Arm

\[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Standard of Care Arm91
Liso-cel Arm92

Reported measurements

Hospitalized
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Standard of Care Arm74Not reportedNot reportedNot reportedNot reported
Liso-cel Arm87Not reportedNot reportedNot reportedNot reported
Hospitalized due to Adverse Event (AE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Standard of Care Arm42Not reportedNot reportedNot reportedNot reported
Liso-cel Arm44Not reportedNot reportedNot reportedNot reported
Hospitalized due to Progression of Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Standard of Care Arm2Not reportedNot reportedNot reportedNot reported
Liso-cel Arm6Not reportedNot reportedNot reportedNot reported
Hospitalized per protocol
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Standard of Care Arm11Not reportedNot reportedNot reportedNot reported
Liso-cel Arm22Not reportedNot reportedNot reportedNot reported
Hospitalized due to other reasons
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Standard of Care Arm56Not reportedNot reportedNot reportedNot reported
Liso-cel Arm71Not reportedNot reportedNot reportedNot reported
Admitted to Intensive Care Unit (ICU)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Standard of Care Arm4Not reportedNot reportedNot reportedNot reported
Liso-cel Arm5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        87
    title
    Hospitalized
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        44
    title
    Hospitalized due to Adverse Event (AE)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        6
    title
    Hospitalized due to Progression of Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        22
    title
    Hospitalized per protocol
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        71
    title
    Hospitalized due to other reasons
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
    title
    Admitted to Intensive Care Unit (ICU)
denoms
  1. counts
    1. group Id
      OG000
      value
      91
    2. group Id
      OG001
      value
      92
    units
    Participants
description
Hospital resource utilization (HRU) results including hospitalized, reasons for hospitalizations, and admitted to intensive care unit (ICU)
groups
  1. description
    3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
    id
    OG000
    title
    Standard of Care Arm
  2. description
    \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
    id
    OG001
    title
    Liso-cel Arm
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants treated in any study medication
reporting Status
POSTED
time Frame
Up to 36 months
title
Hospital Resource Utilization (HRU) Results
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice