NCT03462719 · OUTCOME
Time to Worsening Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) · Source last updated 2026-08-31
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 2 years 10 months
What was measured
Time to worsening= time interval from randomization to first observation of deterioration. EORTC QLQ-C30 includes 30 separate items: 5 functional scales (physical, role, emotional, cognitive, and social Functioning), 1 global health status (GHS) and QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each item, except GHS, is answered on 4-point scale (1=not at all to 4=very much) and GHS is measured on 1-7 scale: 1=very poor and 7=excellent. Scores derived using validated scoring algorithms as per EORTC QLQ-C30 Manual and linearly transformed in a range from 0-100. For functional and global QoL scales, higher scores=better level of functioning/QoL. For symptom-oriented scales, higher score=more severe symptoms. Worsening in functional and global health scores=decrease of \>=10 points (on 0-100 scale) and in symptom scores=increase of \>=10 points (on 0-100 scale).
Analysis population: The ITT analysis set included all randomized participants who were analyzed according to assigned treatment group, regardless of the actual treatment received.
Groups in this outcome
Treatment Arm A (Ibrutinib + Venetoclax)
Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
Treatment Arm B (Chlorambucil + Obinutuzumab)
Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mgs intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is of 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
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 |
|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | 106 |
|---|
| Treatment Arm B (Chlorambucil + Obinutuzumab) | 105 |
|---|
Reported measurements
Global Health Status
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | 14.95 | Not reported | 8.38 | NA | Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events. |
|---|
| Treatment Arm B (Chlorambucil + Obinutuzumab) | 24.18 | Not reported | 13.86 | NA | Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events. |
|---|
Cognitive Functioning
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | 11.07 | Not reported | 5.95 | 24.05 | Not reported |
|---|
| Treatment Arm B (Chlorambucil + Obinutuzumab) | 14.03 | Not reported | 7.16 | NA | Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events. |
|---|
Emotional Functioning
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | NA | Not reported | 17.31 | NA | Here "NA" indicates that median and upper limit of 95% CI was not estimable due to insufficient number of events. |
|---|
| Treatment Arm B (Chlorambucil + Obinutuzumab) | 25.00 | Not reported | 16.62 | NA | Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events |
|---|
Physical Functioning
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | NA | Not reported | 19.42 | NA | Here "NA" indicates that median and upper limit of 95% CI was not estimable due to insufficient number of events. |
|---|
| Treatment Arm B (Chlorambucil + Obinutuzumab) | NA | Not reported | 14.03 | NA | Here "NA" indicates that median and upper limit of 95% CI was not estimable due to insufficient number of events. |
|---|
Role Functioning
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | 11.10 | Not reported | 6.28 | 14.95 | Not reported |
|---|
| Treatment Arm B (Chlorambucil + Obinutuzumab) | 8.48 | Not reported | 5.62 | 16.69 | Not reported |
|---|
Social Functioning
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | 11.10 | Not reported | 8.34 | 16.69 | Not reported |
|---|
| Treatment Arm B (Chlorambucil + Obinutuzumab) | 17.87 | Not reported | 11.07 | 25.30 | Not reported |
|---|
Fatigue (Symptom Scale)
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | 8.38 | Not reported | 5.62 | 14.95 | Not reported |
|---|
| Treatment Arm B (Chlorambucil + Obinutuzumab) | 17.87 | Not reported | 8.44 | NA | Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events. |
|---|
Nausea/Vomiting (Symptom Scale)
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | 11.07 | Not reported | 8.28 | NA | Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events. |
|---|
| Treatment Arm B (Chlorambucil + Obinutuzumab) | NA | Not reported | 20.44 | NA | Here "NA" indicates that median and upper limit of 95% CI was not estimable due to insufficient number of events. |
|---|
Pain (Symptom Scale)
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A (Ibrutinib + Venetoclax) | 8.31 | Not reported | 5.45 | 13.90 | Not reported |
|---|
| Treatment Arm B (Chlorambucil + Obinutuzumab) | 11.01 | Not reported | 5.65 | 17.87 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 8.38
- upper Limit
- NA
- value
- 14.95
- comment
- Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 13.86
- upper Limit
- NA
- value
- 24.18
- title
- Global Health Status
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.95
- upper Limit
- 24.05
- value
- 11.07
- comment
- Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 7.16
- upper Limit
- NA
- value
- 14.03
- title
- Cognitive Functioning
- categories
- measurements
- comment
- Here "NA" indicates that median and upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 17.31
- upper Limit
- NA
- value
- NA
- comment
- Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events
- group Id
- OG001
- lower Limit
- 16.62
- upper Limit
- NA
- value
- 25.00
- title
- Emotional Functioning
- categories
- measurements
- comment
- Here "NA" indicates that median and upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 19.42
- upper Limit
- NA
- value
- NA
- comment
- Here "NA" indicates that median and upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 14.03
- upper Limit
- NA
- value
- NA
- title
- Physical Functioning
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.28
- upper Limit
- 14.95
- value
- 11.10
- group Id
- OG001
- lower Limit
- 5.62
- upper Limit
- 16.69
- value
- 8.48
- title
- Role Functioning
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.34
- upper Limit
- 16.69
- value
- 11.10
- group Id
- OG001
- lower Limit
- 11.07
- upper Limit
- 25.30
- value
- 17.87
- title
- Social Functioning
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.62
- upper Limit
- 14.95
- value
- 8.38
- comment
- Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 8.44
- upper Limit
- NA
- value
- 17.87
- title
- Fatigue (Symptom Scale)
- categories
- measurements
- comment
- Here "NA" indicates that upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 8.28
- upper Limit
- NA
- value
- 11.07
- comment
- Here "NA" indicates that median and upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 20.44
- upper Limit
- NA
- value
- NA
- title
- Nausea/Vomiting (Symptom Scale)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.45
- upper Limit
- 13.90
- value
- 8.31
- group Id
- OG001
- lower Limit
- 5.65
- upper Limit
- 17.87
- value
- 11.01
- title
- Pain (Symptom Scale)
- denoms
- counts
- group Id
- OG000
- value
- 106
- group Id
- OG001
- value
- 105
- units
- Participants
- description
- Time to worsening= time interval from randomization to first observation of deterioration. EORTC QLQ-C30 includes 30 separate items: 5 functional scales (physical, role, emotional, cognitive, and social Functioning), 1 global health status (GHS) and QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each item, except GHS, is answered on 4-point scale (1=not at all to 4=very much) and GHS is measured on 1-7 scale: 1=very poor and 7=excellent. Scores derived using validated scoring algorithms as per EORTC QLQ-C30 Manual and linearly transformed in a range from 0-100. For functional and global QoL scales, higher scores=better level of functioning/QoL. For symptom-oriented scales, higher score=more severe symptoms. Worsening in functional and global health scores=decrease of \>=10 points (on 0-100 scale) and in symptom scores=increase of \>=10 points (on 0-100 scale).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Treatment Arm A (Ibrutinib + Venetoclax)
- description
- Participants received chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight orally once daily on Days 1 and 15 of Cycles 1 to 6 in combination with obinutuzumab 1000 mgs intravenously (IV) once daily on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 (each cycle is of 28 days). Participants who subsequently developed IRC-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Treatment Arm B (Chlorambucil + Obinutuzumab)
- param Type
- MEDIAN
- population Description
- The ITT analysis set included all randomized participants who were analyzed according to assigned treatment group, regardless of the actual treatment received.
- reporting Status
- POSTED
- time Frame
- Up to 2 years 10 months
- title
- Time to Worsening Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)
- type
- SECONDARY
- unit Of Measure
- Months
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