NCT03484702 · OUTCOME
Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores
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
- MEAN
- Unit
- Scores on a Scale
- Interval / dispersion
- Standard Deviation
- Time frame
- At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion.
What was measured
The Functional Assessment of Cancer Treatment-Lymphoma "Additional concerns" subscale (FACT-LymS) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. Only the LYM subscale was administered in this study. The LYM items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. Lower scores indicate better health outcomes. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion.
Analysis population: All participants in the JCAR017-treated set with completed baseline questionnaires and with at least one completed post-baseline questionnaire.
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 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 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 | 23 |
|---|
| 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
Change from baseline Day 1
Analysis denominator · Participants
| 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 | 23 |
|---|
| 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 |
|---|
Values in Scores on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 0.7 | 8.17 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 0.1 | 7.05 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 1.9 | 5.92 | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1.0 | NA | Not reported | Not reported | Insufficient number of participants to calculate standard deviation. |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | -4.0 | 6.52 | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | -1.2 | 11.08 | Not reported | Not reported | Not reported |
|---|
Change from baseline Day 29
Analysis denominator · Participants
| 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 | 19 |
|---|
| 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 | 4 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 9 |
|---|
Values in Scores on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | -1.7 | 7.14 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | -2.7 | 4.56 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 1.3 | 7.24 | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | -4.0 | NA | Not reported | Not reported | Insufficient number of participants to calculate standard deviation. |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | -6.5 | 8.10 | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 1.0 | 9.08 | Not reported | Not reported | Not reported |
|---|
Change from baseline Day 60
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 30 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 17 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 6 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 3 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 9 |
|---|
Values in Scores on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | -2.8 | 5.42 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | -2.0 | 4.20 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | -3.3 | 9.99 | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | -4.0 | NA | Not reported | Not reported | Insufficient number of participants to calculate standard deviation. |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | -4.7 | 8.33 | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | -0.4 | 9.95 | Not reported | Not reported | Not reported |
|---|
Change from baseline Day 90
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 27 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 13 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 7 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 3 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 9 |
|---|
Values in Scores on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | -0.4 | 5.42 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | -2.8 | 3.83 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 0.6 | 9.25 | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | -5.0 | NA | Not reported | Not reported | Insufficient number of participants to calculate standard deviation. |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | -6.7 | 8.50 | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | -1.7 | 8.67 | Not reported | Not reported | Not reported |
|---|
Change from baseline Day 180
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 12 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 8 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 7 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 3 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 6 |
|---|
Values in Scores on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 0.6 | 5.14 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | -1.8 | 5.65 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | -3.6 | 10.20 | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 2.0 | NA | Not reported | Not reported | Insufficient number of participants to calculate standard deviation. |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | -8.0 | 7.00 | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 1.0 | 7.27 | Not reported | Not reported | Not reported |
|---|
Change from baseline Day 270
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 12 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 6 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 5 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 3 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 5 |
|---|
Values in Scores on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | -0.3 | 6.78 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | -3.7 | 2.25 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | -1.0 | 10.07 | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | -8.0 | NA | Not reported | Not reported | Insufficient number of participants to calculate standard deviation. |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | -10.00 | 12.53 | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 2.4 | 5.22 | Not reported | Not reported | Not reported |
|---|
Change from baseline Day 365
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 10 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 7 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 4 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 3 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 5 |
|---|
Values in Scores on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 1.3 | 7.01 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | -3.3 | 3.30 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 2.0 | 12.03 | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | -6.0 | NA | Not reported | Not reported | Insufficient number of participants to calculate standard deviation. |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | -6.7 | 10.69 | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 1.4 | 7.33 | Not reported | Not reported | Not reported |
|---|
Change from baseline Day 545
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 9 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 7 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 3 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 2 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 5 |
|---|
Values in Scores on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 0.7 | 7.14 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | -3.7 | 4.35 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | -4.7 | 4.16 | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | -3.0 | NA | Not reported | Not reported | Insufficient number of participants to calculate standard deviation. |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 3.5 | 6.36 | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | -1.0 | 4.85 | Not reported | Not reported | Not reported |
|---|
Change from baseline Day 730
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 12 |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 6 |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 4 |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | 2 |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | 4 |
|---|
Values in Scores on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 1.4 | 7.12 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | -0.8 | 1.33 | Not reported | Not reported | Not reported |
|---|
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | -1.8 | 5.32 | Not reported | Not reported | Not reported |
|---|
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | -2.0 | NA | Not reported | Not reported | Insufficient number of participants to calculate standard deviation. |
|---|
| Cohort 5: Primary Central Nervous System Lymphoma | -1.5 | 12.02 | Not reported | Not reported | Not reported |
|---|
| Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting | -1.5 | 1.29 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 8.17
- value
- 0.7
- group Id
- OG001
- spread
- 7.05
- value
- 0.1
- group Id
- OG002
- spread
- 5.92
- value
- 1.9
- comment
- Insufficient number of participants to calculate standard deviation.
- group Id
- OG003
- spread
- NA
- value
- 1.0
- group Id
- OG004
- spread
- 6.52
- value
- -4.0
- group Id
- OG005
- spread
- 11.08
- value
- -1.2
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 9
- units
- Participants
- title
- Change from baseline Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 7.14
- value
- -1.7
- group Id
- OG001
- spread
- 4.56
- value
- -2.7
- group Id
- OG002
- spread
- 7.24
- value
- 1.3
- comment
- Insufficient number of participants to calculate standard deviation.
- group Id
- OG003
- spread
- NA
- value
- -4.0
- group Id
- OG004
- spread
- 8.10
- value
- -6.5
- group Id
- OG005
- spread
- 9.08
- value
- 1.0
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 9
- units
- Participants
- title
- Change from baseline Day 29
- categories
- measurements
- group Id
- OG000
- spread
- 5.42
- value
- -2.8
- group Id
- OG001
- spread
- 4.20
- value
- -2.0
- group Id
- OG002
- spread
- 9.99
- value
- -3.3
- comment
- Insufficient number of participants to calculate standard deviation.
- group Id
- OG003
- spread
- NA
- value
- -4.0
- group Id
- OG004
- spread
- 8.33
- value
- -4.7
- group Id
- OG005
- spread
- 9.95
- value
- -0.4
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 9
- units
- Participants
- title
- Change from baseline Day 60
- categories
- measurements
- group Id
- OG000
- spread
- 5.42
- value
- -0.4
- group Id
- OG001
- spread
- 3.83
- value
- -2.8
- group Id
- OG002
- spread
- 9.25
- value
- 0.6
- comment
- Insufficient number of participants to calculate standard deviation.
- group Id
- OG003
- spread
- NA
- value
- -5.0
- group Id
- OG004
- spread
- 8.50
- value
- -6.7
- group Id
- OG005
- spread
- 8.67
- value
- -1.7
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 9
- units
- Participants
- title
- Change from baseline Day 90
- categories
- measurements
- group Id
- OG000
- spread
- 5.14
- value
- 0.6
- group Id
- OG001
- spread
- 5.65
- value
- -1.8
- group Id
- OG002
- spread
- 10.20
- value
- -3.6
- comment
- Insufficient number of participants to calculate standard deviation.
- group Id
- OG003
- spread
- NA
- value
- 2.0
- group Id
- OG004
- spread
- 7.00
- value
- -8.0
- group Id
- OG005
- spread
- 7.27
- value
- 1.0
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- units
- Participants
- title
- Change from baseline Day 180
- categories
- measurements
- group Id
- OG000
- spread
- 6.78
- value
- -0.3
- group Id
- OG001
- spread
- 2.25
- value
- -3.7
- group Id
- OG002
- spread
- 10.07
- value
- -1.0
- comment
- Insufficient number of participants to calculate standard deviation.
- group Id
- OG003
- spread
- NA
- value
- -8.0
- group Id
- OG004
- spread
- 12.53
- value
- -10.00
- group Id
- OG005
- spread
- 5.22
- value
- 2.4
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 5
- units
- Participants
- title
- Change from baseline Day 270
- categories
- measurements
- group Id
- OG000
- spread
- 7.01
- value
- 1.3
- group Id
- OG001
- spread
- 3.30
- value
- -3.3
- group Id
- OG002
- spread
- 12.03
- value
- 2.0
- comment
- Insufficient number of participants to calculate standard deviation.
- group Id
- OG003
- spread
- NA
- value
- -6.0
- group Id
- OG004
- spread
- 10.69
- value
- -6.7
- group Id
- OG005
- spread
- 7.33
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 5
- units
- Participants
- title
- Change from baseline Day 365
- categories
- measurements
- group Id
- OG000
- spread
- 7.14
- value
- 0.7
- group Id
- OG001
- spread
- 4.35
- value
- -3.7
- group Id
- OG002
- spread
- 4.16
- value
- -4.7
- comment
- Insufficient number of participants to calculate standard deviation.
- group Id
- OG003
- spread
- NA
- value
- -3.0
- group Id
- OG004
- spread
- 6.36
- value
- 3.5
- group Id
- OG005
- spread
- 4.85
- value
- -1.0
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 5
- units
- Participants
- title
- Change from baseline Day 545
- categories
- measurements
- group Id
- OG000
- spread
- 7.12
- value
- 1.4
- group Id
- OG001
- spread
- 1.33
- value
- -0.8
- group Id
- OG002
- spread
- 5.32
- value
- -1.8
- comment
- Insufficient number of participants to calculate standard deviation.
- group Id
- OG003
- spread
- NA
- value
- -2.0
- group Id
- OG004
- spread
- 12.02
- value
- -1.5
- group Id
- OG005
- spread
- 1.29
- value
- -1.5
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 4
- units
- Participants
- title
- Change from baseline Day 730
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 9
- units
- Participants
- description
- The Functional Assessment of Cancer Treatment-Lymphoma "Additional concerns" subscale (FACT-LymS) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. Only the LYM subscale was administered in this study. The LYM items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. Lower scores indicate better health outcomes. Baseline the last available recorded scores on or prior to the date of JCAR017 infusion.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- All participants in the JCAR017-treated set with completed baseline questionnaires and with at least one completed post-baseline questionnaire.
- reporting Status
- POSTED
- time Frame
- At baseline and Day 1, 29, 60, 90, 180, 270, 365, 545, and 730 post JCAR017 infusion.
- title
- Change From Baseline in Functional Assessment of Cancer Treatment-Lymphoma "Additional Concerns" Subscale (FACT-LymS) Scores
- type
- SECONDARY
- unit Of Measure
- Scores on a Scale
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Preserved source evidence · Not medical advice
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