NCT03575351 · OUTCOME
Change From Baseline in Hematology Parameters 1: Hemoglobin
A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas · Source last updated 2025-08-03
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- g/L
- Interval / dispersion
- Standard Deviation
- Time frame
- baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36
What was measured
Change from baseline in hemoglobin. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).
Analysis population: All treated participants with a baseline value and a post-baseline value at the time point
Groups in this outcome
Standard of Care Arm
3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Liso-cel Arm
\[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD 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 |
|---|
| Standard of Care Arm | 73 |
|---|
| Liso-cel Arm | 84 |
|---|
Reported measurements
Hemoglobin Month 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 73 |
|---|
| Liso-cel Arm | 84 |
|---|
Values in g/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | -16.98 | 13.408 | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | -14.94 | 14.628 | Not reported | Not reported | Not reported |
|---|
Hemoglobin Month 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 1 |
|---|
| Liso-cel Arm | 0 |
|---|
Values in g/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | -25.00 | NA | Not reported | Not reported | insufficient number of participants to calculate standard deviation |
|---|
Hemoglobin Month 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 41 |
|---|
| Liso-cel Arm | 72 |
|---|
Values in g/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | -30.83 | 19.013 | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | -15.78 | 19.410 | Not reported | Not reported | Not reported |
|---|
Hemoglobin Month 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 1 |
|---|
| Liso-cel Arm | 0 |
|---|
Values in g/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | -22.00 | NA | Not reported | Not reported | insufficient number of participants to calculate standard deviation |
|---|
Hemoglobin Month 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 30 |
|---|
| Liso-cel Arm | 62 |
|---|
Values in g/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | -6.80 | 14.935 | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | -3.16 | 19.755 | Not reported | Not reported | Not reported |
|---|
Hemoglobin Month 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 22 |
|---|
| Liso-cel Arm | 60 |
|---|
Values in g/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | 0.36 | 19.242 | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | -0.52 | 15.632 | Not reported | Not reported | Not reported |
|---|
Hemoglobin Month 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 18 |
|---|
| Liso-cel Arm | 59 |
|---|
Values in g/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | 6.17 | 14.598 | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | 3.32 | 15.417 | Not reported | Not reported | Not reported |
|---|
Hemoglobin Month 18
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 19 |
|---|
| Liso-cel Arm | 52 |
|---|
Values in g/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | 11.37 | 14.592 | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | 7.38 | 12.854 | Not reported | Not reported | Not reported |
|---|
Hemoglobin Month 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 17 |
|---|
| Liso-cel Arm | 45 |
|---|
Values in g/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | 13.88 | 18.996 | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | 7.38 | 16.986 | Not reported | Not reported | Not reported |
|---|
Hemoglobin Month 36
Analysis denominator · Participants
| Group | Source count |
|---|
| Standard of Care Arm | 17 |
|---|
| Liso-cel Arm | 41 |
|---|
Values in g/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Standard of Care Arm | 14.41 | 16.978 | Not reported | Not reported | Not reported |
|---|
| Liso-cel Arm | 13.63 | 12.417 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 13.408
- value
- -16.98
- group Id
- OG001
- spread
- 14.628
- value
- -14.94
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 84
- units
- Participants
- title
- Hemoglobin Month 1
- categories
- measurements
- comment
- insufficient number of participants to calculate standard deviation
- group Id
- OG000
- spread
- NA
- value
- -25.00
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Hemoglobin Month 2
- categories
- measurements
- group Id
- OG000
- spread
- 19.013
- value
- -30.83
- group Id
- OG001
- spread
- 19.410
- value
- -15.78
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 72
- units
- Participants
- title
- Hemoglobin Month 3
- categories
- measurements
- comment
- insufficient number of participants to calculate standard deviation
- group Id
- OG000
- spread
- NA
- value
- -22.00
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Hemoglobin Month 4
- categories
- measurements
- group Id
- OG000
- spread
- 14.935
- value
- -6.80
- group Id
- OG001
- spread
- 19.755
- value
- -3.16
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 62
- units
- Participants
- title
- Hemoglobin Month 6
- categories
- measurements
- group Id
- OG000
- spread
- 19.242
- value
- 0.36
- group Id
- OG001
- spread
- 15.632
- value
- -0.52
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 60
- units
- Participants
- title
- Hemoglobin Month 9
- categories
- measurements
- group Id
- OG000
- spread
- 14.598
- value
- 6.17
- group Id
- OG001
- spread
- 15.417
- value
- 3.32
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 59
- units
- Participants
- title
- Hemoglobin Month 12
- categories
- measurements
- group Id
- OG000
- spread
- 14.592
- value
- 11.37
- group Id
- OG001
- spread
- 12.854
- value
- 7.38
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 52
- units
- Participants
- title
- Hemoglobin Month 18
- categories
- measurements
- group Id
- OG000
- spread
- 18.996
- value
- 13.88
- group Id
- OG001
- spread
- 16.986
- value
- 7.38
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 45
- units
- Participants
- title
- Hemoglobin Month 24
- categories
- measurements
- group Id
- OG000
- spread
- 16.978
- value
- 14.41
- group Id
- OG001
- spread
- 12.417
- value
- 13.63
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 41
- units
- Participants
- title
- Hemoglobin Month 36
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 84
- units
- Participants
- description
- Change from baseline in hemoglobin. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).
- dispersion Type
- Standard Deviation
- groups
- description
- 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
- id
- OG000
- title
- Standard of Care Arm
- description
- \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
- id
- OG001
- title
- Liso-cel Arm
- param Type
- MEAN
- population Description
- All treated participants with a baseline value and a post-baseline value at the time point
- reporting Status
- POSTED
- time Frame
- baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36
- title
- Change From Baseline in Hematology Parameters 1: Hemoglobin
- type
- SECONDARY
- unit Of Measure
- g/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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