TriangleNCT03484702 · OUTCOME
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5
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
- At Baseline and Day 29 after JCAR017 infusion
What was measured
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death.
Analysis population: All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only
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).
| Group | Source count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 33 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 21 |
| 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 |
Reported measurements
Leukocytes (10^9/L) - Day 29
| Group | Source count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 33 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 21 |
| 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 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Primary Central Nervous System Lymphoma | 1 | Not reported | Not reported | Not reported | Not reported |
Neutrophils, Segmented (10^9/L) - Day 29
| Group | Source count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 33 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 21 |
| 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 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Primary Central Nervous System Lymphoma | 1 | Not reported | Not reported | Not reported | Not reported |
Platelets (10^9/L) - Day 29
| Group | Source count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 29 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 20 |
| 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 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 13 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Primary Central Nervous System Lymphoma | 3 | Not reported | Not reported | Not reported | Not reported |
Activated Partial Thromboplastin Time (sec) - Day 29
| Group | Source count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 32 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 18 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 8 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
| Cohort 5: Primary Central Nervous System Lymphoma | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Primary Central Nervous System Lymphoma | 1 | Not reported | Not reported | Not reported | Not reported |
Prothrombin Intl. Normalized Ratio - Day 29
| Group | Source count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 32 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 21 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 8 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
| Cohort 5: Primary Central Nervous System Lymphoma | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Primary Central Nervous System Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- Leukocytes (10^9/L) - Day 29
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- Neutrophils, Segmented (10^9/L) - Day 29
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- Platelets (10^9/L) - Day 29
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- units
- Participants
- title
- Activated Partial Thromboplastin Time (sec) - Day 29
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- units
- Participants
- title
- Prothrombin Intl. Normalized Ratio - Day 29
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- units
- Participants
- description
- JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 = Mild, Grade 2 =Moderate, Grade 3 =Severe, Grade 4 =Life-threatening, Grade 5 =Death.
- 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
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants in the JCAR017 treated set with available baseline and Day 29 hematology results. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only
- reporting Status
- POSTED
- time Frame
- At Baseline and Day 29 after JCAR017 infusion
- title
- Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohorts 1, 2, 3, 4, and 5
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice