NCT02348216 · OUTCOME
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma · Source last updated 2024-06-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 5.4 years)
What was measured
TEAE was defined as any AE with onset on or after the start of treatment. CRS events were graded by Lee et al 2014. Grade 1 : No life threatening symptoms and require symptomatic treatment only; Grade 2: Symptoms require and respond to moderate intervention; Grade 3: Symptoms require and respond to aggressive intervention; Grade 4: Life-threatening symptoms and requirements for ventilator support or CVVHD, and Grade 5: Death. Neurologic toxicities were graded by CTCAE version 4.03. Grade 1: Mild, asymptomatic or mild symptoms and intervention not indicated; Grade 2: Moderate and minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening and urgent intervention indicated; Grade 5: Death related to AE.
Analysis population: The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel.
Groups in this outcome
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
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 |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 41 |
|---|
Reported measurements
Worst Grade 1 CRS
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 32 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst Grade 2 CRS
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 59 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst Grade 3 CRS
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst Grade 4 CRS
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst Grade 5 CRS
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst Grade ≥ 3 CRS
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst Grade 1 Neurologic Toxicities
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst Grade 2 Neurologic Toxicities
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst Grade 3 Neurologic Toxicities
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst Grade 4 Neurologic Toxicities
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst Grade 5 Neurologic Toxicities
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst Grade ≥ 3 Neurologic Toxicities
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Worst Grade 1 CRS
- title
- Worst Grade 2 CRS
- title
- Worst Grade 3 CRS
- title
- Worst Grade 4 CRS
- title
- Worst Grade 5 CRS
- title
- Worst Grade ≥ 3 CRS
- title
- Worst Grade 1 Neurologic Toxicities
- title
- Worst Grade 2 Neurologic Toxicities
- title
- Worst Grade 3 Neurologic Toxicities
- title
- Worst Grade 4 Neurologic Toxicities
- title
- Worst Grade 5 Neurologic Toxicities
- title
- Worst Grade ≥ 3 Neurologic Toxicities
- description
- TEAE was defined as any AE with onset on or after the start of treatment. CRS events were graded by Lee et al 2014. Grade 1 : No life threatening symptoms and require symptomatic treatment only; Grade 2: Symptoms require and respond to moderate intervention; Grade 3: Symptoms require and respond to aggressive intervention; Grade 4: Life-threatening symptoms and requirements for ventilator support or CVVHD, and Grade 5: Death. Neurologic toxicities were graded by CTCAE version 4.03. Grade 1: Mild, asymptomatic or mild symptoms and intervention not indicated; Grade 2: Moderate and minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening and urgent intervention indicated; Grade 5: Death related to AE.
- groups
- description
- Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
- id
- OG000
- title
- Phase 2 (Safety Management Study): Cohort 4
- param Type
- NUMBER
- population Description
- The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel.
- reporting Status
- POSTED
- time Frame
- First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 5.4 years)
- title
- Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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