NCT02348216 · OUTCOME
Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
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
- MEDIAN
- Unit
- pg/mL
- Interval / dispersion
- Full Range
- Time frame
- Baseline up to Month 3
What was measured
Peak was defined as the maximum post-baseline level of the cytokine. Following key cytokines were measured: IP-10, granzyme B, IFN-gamma, IL-1 RA, IL-2, IL-6, IL-7, IL-8, IL-10, IL-15, TNF alpha, and granulocyte-macrophage colony-stimulating factor (GM-CSF).
Analysis population: Participants in the Safety Analysis Set with available data were analyzed.
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).
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), 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 at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received 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 on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). 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 |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
|---|
Reported measurements
IP-10
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 41 |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
|---|
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 1549.70 | Not reported | 469.20 | 2000.00 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 1746.15 | Not reported | 349.80 | 2000.00 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 1560.03 | Not reported | 347.00 | 2000.000 | Not reported |
|---|
Granzyme B
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 41 |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
|---|
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 23.10 | Not reported | 1.00 | 322.60 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 27.90 | Not reported | 1.00 | 375.76 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 18.40 | Not reported | 1.00 | 162.30 | Not reported |
|---|
IFN-gamma
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 41 |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
|---|
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 334.50 | Not reported | 24.90 | 1876.00 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 314.90 | Not reported | 7.50 | 1876.00 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 207.95 | Not reported | 18.80 | 1876.00 | Not reported |
|---|
IL-1 RA
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 31 |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
|---|
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 1093.70 | Not reported | 193.30 | 4493.10 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 908.00 | Not reported | 229.00 | 9000.00 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 1279.50 | Not reported | 227.00 | 9000.00 | Not reported |
|---|
IL-2
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 41 |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
|---|
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 11.20 | Not reported | 0.90 | 79.40 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 11.85 | Not reported | 0.90 | 142.70 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 8.40 | Not reported | 0.90 | 277.60 | Not reported |
|---|
IL-6
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 41 |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
|---|
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 136.70 | Not reported | 1.60 | 976.00 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 97.95 | Not reported | 1.60 | 976.00 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 47.25 | Not reported | 1.60 | 976.00 | Not reported |
|---|
IL-7
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 41 |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
|---|
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 33.10 | Not reported | 18.00 | 67.50 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 29.80 | Not reported | 1.40 | 65.20 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 28.25 | Not reported | 13.20 | 74.30 | Not reported |
|---|
IL-8
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 41 |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
|---|
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 67.40 | Not reported | 8.50 | 750.00 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 75.10 | Not reported | 5.80 | 750.00 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 52.55 | Not reported | 10.00 | 750.00 | Not reported |
|---|
IL-10
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 41 |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
|---|
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 19.60 | Not reported | 1.40 | 466.00 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 14.45 | Not reported | 0.70 | 300.90 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 13.30 | Not reported | 0.70 | 171.20 | Not reported |
|---|
IL-15
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 41 |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
|---|
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 45.80 | Not reported | 22.30 | 272.70 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 34.15 | Not reported | 1.40 | 140.00 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 37.20 | Not reported | 9.50 | 86.30 | Not reported |
|---|
TNF alpha
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 41 |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
|---|
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 5.70 | Not reported | 2.00 | 54.60 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 5.25 | Not reported | 1.40 | 33.30 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 4.80 | Not reported | 2.10 | 20.20 | Not reported |
|---|
GM-CSF
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 41 |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
|---|
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 (Safety Management Study): Cohort 4 | 4.40 | Not reported | 1.90 | 47.00 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 5 | 2.90 | Not reported | 1.90 | 35.60 | Not reported |
|---|
| Phase 2 (Safety Management Study): Cohort 6 | 1.90 | Not reported | 1.90 | 47.40 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 469.20
- upper Limit
- 2000.00
- value
- 1549.70
- group Id
- OG001
- lower Limit
- 349.80
- upper Limit
- 2000.00
- value
- 1746.15
- group Id
- OG002
- lower Limit
- 347.00
- upper Limit
- 2000.000
- value
- 1560.03
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- IP-10
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 322.60
- value
- 23.10
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 375.76
- value
- 27.90
- group Id
- OG002
- lower Limit
- 1.00
- upper Limit
- 162.30
- value
- 18.40
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- Granzyme B
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.90
- upper Limit
- 1876.00
- value
- 334.50
- group Id
- OG001
- lower Limit
- 7.50
- upper Limit
- 1876.00
- value
- 314.90
- group Id
- OG002
- lower Limit
- 18.80
- upper Limit
- 1876.00
- value
- 207.95
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- IFN-gamma
- categories
- measurements
- group Id
- OG000
- lower Limit
- 193.30
- upper Limit
- 4493.10
- value
- 1093.70
- group Id
- OG001
- lower Limit
- 229.00
- upper Limit
- 9000.00
- value
- 908.00
- group Id
- OG002
- lower Limit
- 227.00
- upper Limit
- 9000.00
- value
- 1279.50
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- IL-1 RA
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.90
- upper Limit
- 79.40
- value
- 11.20
- group Id
- OG001
- lower Limit
- 0.90
- upper Limit
- 142.70
- value
- 11.85
- group Id
- OG002
- lower Limit
- 0.90
- upper Limit
- 277.60
- value
- 8.40
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- IL-2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.60
- upper Limit
- 976.00
- value
- 136.70
- group Id
- OG001
- lower Limit
- 1.60
- upper Limit
- 976.00
- value
- 97.95
- group Id
- OG002
- lower Limit
- 1.60
- upper Limit
- 976.00
- value
- 47.25
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- IL-6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.00
- upper Limit
- 67.50
- value
- 33.10
- group Id
- OG001
- lower Limit
- 1.40
- upper Limit
- 65.20
- value
- 29.80
- group Id
- OG002
- lower Limit
- 13.20
- upper Limit
- 74.30
- value
- 28.25
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- IL-7
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.50
- upper Limit
- 750.00
- value
- 67.40
- group Id
- OG001
- lower Limit
- 5.80
- upper Limit
- 750.00
- value
- 75.10
- group Id
- OG002
- lower Limit
- 10.00
- upper Limit
- 750.00
- value
- 52.55
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- IL-8
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.40
- upper Limit
- 466.00
- value
- 19.60
- group Id
- OG001
- lower Limit
- 0.70
- upper Limit
- 300.90
- value
- 14.45
- group Id
- OG002
- lower Limit
- 0.70
- upper Limit
- 171.20
- value
- 13.30
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- IL-10
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22.30
- upper Limit
- 272.70
- value
- 45.80
- group Id
- OG001
- lower Limit
- 1.40
- upper Limit
- 140.00
- value
- 34.15
- group Id
- OG002
- lower Limit
- 9.50
- upper Limit
- 86.30
- value
- 37.20
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- IL-15
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.00
- upper Limit
- 54.60
- value
- 5.70
- group Id
- OG001
- lower Limit
- 1.40
- upper Limit
- 33.30
- value
- 5.25
- group Id
- OG002
- lower Limit
- 2.10
- upper Limit
- 20.20
- value
- 4.80
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- TNF alpha
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.90
- upper Limit
- 47.00
- value
- 4.40
- group Id
- OG001
- lower Limit
- 1.90
- upper Limit
- 35.60
- value
- 2.90
- group Id
- OG002
- lower Limit
- 1.90
- upper Limit
- 47.40
- value
- 1.90
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 40
- units
- Participants
- title
- GM-CSF
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 40
- units
- Participants
- description
- Peak was defined as the maximum post-baseline level of the cytokine. Following key cytokines were measured: IP-10, granzyme B, IFN-gamma, IL-1 RA, IL-2, IL-6, IL-7, IL-8, IL-10, IL-15, TNF alpha, and granulocyte-macrophage colony-stimulating factor (GM-CSF).
- dispersion Type
- Full Range
- 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
- description
- Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), 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 at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
- id
- OG001
- title
- Phase 2 (Safety Management Study): Cohort 5
- description
- Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received 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 on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). 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
- OG002
- title
- Phase 2 (Safety Management Study): Cohort 6
- param Type
- MEDIAN
- population Description
- Participants in the Safety Analysis Set with available data were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline up to Month 3
- title
- Pharmacodynamics: Peak Level of Cytokines (IP-10, Granzyme B, IFN-gamma, IL-1 RA, IL-10, IL-15, IL-2, IL-6, IL-7, IL-8, TNF Alpha, and GM-CSF) in Serum (Phase 2 Cohorts 4, 5, and 6)
- type
- SECONDARY
- unit Of Measure
- pg/mL
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Preserved source evidence · Not medical advice
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