TriangleNCT03484702 · OUTCOME
Complete Response Rate (CRR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percent of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)
What was measured
Complete response rate is defined as percentage of participants achieving a best overall response of complete response. Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: None * New lesions: No * Bone marrow: Normal Complete response (CR) (Cohort 5): * Brain imaging: No contrast enhancement * Corticosteroid dose: None * Eye examination: Normal * Cerebrospinal fluid cytology: Negative Complete response unconfirmed (CRu) (Cohort 5): * Brain imaging: No contrast enhancement, Minimal abnormality * Corticosteroid dose: Any * Eye examination: Normal, minor RPE abnormality * Cerebrospinal fluid cytology: Negative
Analysis population: All participants in the JCAR017 treated set.
Groups in this outcome
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 5: Primary Central Nervous System Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
| Group | Source count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 36 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 27 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 10 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
| Cohort 5: Primary Central Nervous System Lymphoma | 5 |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 33.3 | Not reported | 18.6 | 51.0 | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 48.1 | Not reported | 28.7 | 68.1 | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 50.0 | Not reported | 18.7 | 81.3 | Not reported |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0 | Not reported | 0 | 0 | Not reported |
| Cohort 5: Primary Central Nervous System Lymphoma | 0 | Not reported | 0 | 0 | Not reported |
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 88.9 | Not reported | 51.8 | 99.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.6
- upper Limit
- 51.0
- value
- 33.3
- group Id
- OG001
- lower Limit
- 28.7
- upper Limit
- 68.1
- value
- 48.1
- group Id
- OG002
- lower Limit
- 18.7
- upper Limit
- 81.3
- value
- 50.0
- group Id
- OG003
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG004
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG005
- lower Limit
- 51.8
- upper Limit
- 99.7
- value
- 88.9
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 9
- units
- Participants
- description
- Complete response rate is defined as percentage of participants achieving a best overall response of complete response. Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: None * New lesions: No * Bone marrow: Normal Complete response (CR) (Cohort 5): * Brain imaging: No contrast enhancement * Corticosteroid dose: None * Eye examination: Normal * Cerebrospinal fluid cytology: Negative Complete response unconfirmed (CRu) (Cohort 5): * Brain imaging: No contrast enhancement, Minimal abnormality * Corticosteroid dose: Any * Eye examination: Normal, minor RPE abnormality * Cerebrospinal fluid cytology: Negative
- dispersion Type
- 95% Confidence Interval
- groups
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG000
- title
- Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG001
- title
- Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG002
- title
- Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG003
- title
- Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG004
- title
- Cohort 5: Primary Central Nervous System Lymphoma
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG005
- title
- Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
- param Type
- NUMBER
- population Description
- All participants in the JCAR017 treated set.
- reporting Status
- POSTED
- time Frame
- From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)
- title
- Complete Response Rate (CRR)
- type
- SECONDARY
- unit Of Measure
- Percent of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice