NCT03484702 · OUTCOME
Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7
Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma · Source last updated 2024-12-27
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 cohort 7 only
Groups in this outcome
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 9 |
|---|
Reported measurements
Leukocytes (10^9/L) - Day 29
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 9 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Neutrophils, Segmented (10^9/L) - Day 29
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 8 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Platelets (10^9/L) - Day 29
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 9 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Activated Partial Thromboplastin Time (sec) - Day 29
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 9 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Prothrombin Intl. Normalized Ratio - Day 29
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 9 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Leukocytes (10^9/L) - Day 29
- title
- Neutrophils, Segmented (10^9/L) - Day 29
- title
- Platelets (10^9/L) - Day 29
- title
- Activated Partial Thromboplastin Time (sec) - Day 29
- title
- Prothrombin Intl. Normalized Ratio - Day 29
- 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 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
- 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 cohort 7 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 - Cohort 7
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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