NCT03575351 · OUTCOME
Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs)
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
- From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months)
What was measured
A serious adverse event is defined as any adverse event occurring at any dose that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. Treatment emergent adverse events are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Analysis population: All participants treated in any study medication per overall participants and in clinical, histological and molecular subgroups that are prespecified for this endpoint (subgroups are not mutually exclusive)
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
| Group | Source count |
|---|
| Standard of Care Arm | 91 |
|---|
| Liso-cel Arm | 92 |
|---|
Reported measurements
Overall Participants with serious TEAEs
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 91 |
|---|
| Liso-cel Arm | 92 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | 45 | Not reported | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | 43 | Not reported | Not reported | Not reported | Not reported |
|---|
Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) with serious TEAEs
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 58 |
|---|
| Liso-cel Arm | 60 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
NIH: Follicular Lymphoma Grade 3B with serious TEAEs
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 0 |
|---|
| Liso-cel Arm | 1 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Liso-cel Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
NIH: High-Grade B-cell Lymphoma with DLBCL Histology with serious TEAEs
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 20 |
|---|
| Liso-cel Arm | 22 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma with serious TEAEs
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 9 |
|---|
| Liso-cel Arm | 8 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma with serious TEAEs
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 4 |
|---|
| Liso-cel Arm | 1 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo with serious TEAEs
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 50 |
|---|
| Liso-cel Arm | 53 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
DLBCL: DLBCL from Transformed Indolent NHL with serious TEAEs
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 8 |
|---|
| Liso-cel Arm | 7 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 43
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 92
- units
- Participants
- title
- Overall Participants with serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 23
- denoms
- counts
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 60
- units
- Participants
- title
- Non-Hodgkin Lymphoma (NHL): Diffuse Large B-cell Lymphoma (DLBCL) with serious TEAEs
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- NIH: Follicular Lymphoma Grade 3B with serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 17
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 22
- units
- Participants
- title
- NIH: High-Grade B-cell Lymphoma with DLBCL Histology with serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- NIH: Primary Mediastinal (thymic) Large B-cell Lymphoma with serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma with serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 20
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 53
- units
- Participants
- title
- Diffuse Large B-cell Lymphoma (DLBCL): DLBCL NOS de novo with serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- units
- Participants
- title
- DLBCL: DLBCL from Transformed Indolent NHL with serious TEAEs
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 92
- units
- Participants
- description
- A serious adverse event is defined as any adverse event occurring at any dose that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. Treatment emergent adverse events are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
- groups
- 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
- 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 per overall participants and in clinical, histological and molecular subgroups that are prespecified for this endpoint (subgroups are not mutually exclusive)
- reporting Status
- POSTED
- time Frame
- From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 16.5 months)
- title
- Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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