Lymphocytic Leukemia, Chronic
Conditions
Brief summary
This observational study will evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be collected from eligible participants receiving rituximab according to the Summary of Product Characteristics (SPC) during 6 months of treatment.
Interventions
DRUGRituximab
Rituximab will be administered in combination with chemotherapy according to SPC and routine clinical practice.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy according to the approved SPC
Exclusion criteria
\- Contraindications to rituximab therapy according to the approved SPC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | Baseline up to 24 months | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Disease Progression or Death Assessed Using Local Standards | Months 6, 12, 18, and 24 | PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards | Months 6, 12, 18, and 24 | Percentage of participants with CR or PR as determined by the investigator was reported. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Progression-Free Survival (PFS) Assessed Using Local Standards | From enrollment until disease progression or death, assessed up to 24 months | PFS was defined as the time from enrollment to the first documented progression of disease or death due to any cause. Progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. KaplanMeier estimate was used for analysis. |
| Percentage of Participants With PR Assessed Using Local Standards | Months 6, 12, 18, and 24 | Percentage of participants with PR as determined by the investigator was reported. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Time to Progression (TTP) Assessed Using Local Standards | From enrollment until disease progression or death, assessed up to 26 months | TTP is defined as the time from enrollment to the PD. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan-Meier estimate was used for analysis. |
| Percentage of Participants With CR Assessed Using Local Standards | Months 6, 12, 18, and 24 | Percentage of participants with CR as determined by the investigator was reported. CR was defined as disappearance of all target lesions. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituximab Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months. | 67 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Disease progression | 10 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Personal reasons | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Toxicity | 3 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Rituximab |
|---|---|
| Age, Continuous | 69.12 years STANDARD_DEVIATION 10.08 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 67 |
| serious Total, serious adverse events | 33 / 67 |
Outcome results
Primary
Percentage of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Baseline up to 24 months
Population: Safety population included all eligible participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab | Percentage of Participants With Adverse Events (AEs) | 89.6 percentage of participants |
Secondary
Percentage of Participants With CR Assessed Using Local Standards
Percentage of participants with CR as determined by the investigator was reported. CR was defined as disappearance of all target lesions.
Time frame: Months 6, 12, 18, and 24
Population: ITT population. Here, 'Overall Number of Participants Analyzed' = number of participants who were evaluable for this outcome. 'Number Analyzed' = participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Percentage of Participants With CR Assessed Using Local Standards | Month 18 | 37.5 percentage of participants |
| Rituximab | Percentage of Participants With CR Assessed Using Local Standards | Month 6 | 42 percentage of participants |
| Rituximab | Percentage of Participants With CR Assessed Using Local Standards | Month 12 | 41.8 percentage of participants |
| Rituximab | Percentage of Participants With CR Assessed Using Local Standards | Month 24 | 44.1 percentage of participants |
Secondary
Percentage of Participants With Disease Progression or Death Assessed Using Local Standards
PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time frame: Months 6, 12, 18, and 24
Population: ITT population. Here, 'Overall Number of Participants Analyzed' = number of participants who were evaluable for this outcome. 'Number Analyzed' = participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Percentage of Participants With Disease Progression or Death Assessed Using Local Standards | Month 18 | 17.5 percentage of participants |
| Rituximab | Percentage of Participants With Disease Progression or Death Assessed Using Local Standards | Month 24 | 14.7 percentage of participants |
| Rituximab | Percentage of Participants With Disease Progression or Death Assessed Using Local Standards | Month 6 | 5.8 percentage of participants |
| Rituximab | Percentage of Participants With Disease Progression or Death Assessed Using Local Standards | Month 12 | 11.1 percentage of participants |
Secondary
Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards
Percentage of participants with CR or PR as determined by the investigator was reported. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Months 6, 12, 18, and 24
Population: ITT population. Here, 'Overall Number of Participants Analyzed' = number of participants who were evaluable for this outcome. 'Number Analyzed' = participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards | Month 6 | 84 percentage of participants |
| Rituximab | Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards | Month 12 | 72.1 percentage of participants |
| Rituximab | Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards | Month 18 | 58.5 percentage of participants |
| Rituximab | Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards | Month 24 | 67.6 percentage of participants |
Secondary
Percentage of Participants With PR Assessed Using Local Standards
Percentage of participants with PR as determined by the investigator was reported. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time frame: Months 6, 12, 18, and 24
Population: ITT population. Here, 'Overall Number of Participants Analyzed' = number of participants who were evaluable for this outcome. 'Number Analyzed' = participants who were evaluable for specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Percentage of Participants With PR Assessed Using Local Standards | Month 6 | 42 percentage of participants |
| Rituximab | Percentage of Participants With PR Assessed Using Local Standards | Month 12 | 30.2 percentage of participants |
| Rituximab | Percentage of Participants With PR Assessed Using Local Standards | Month 18 | 22.5 percentage of participants |
| Rituximab | Percentage of Participants With PR Assessed Using Local Standards | Month 24 | 23.5 percentage of participants |
Secondary
Progression-Free Survival (PFS) Assessed Using Local Standards
PFS was defined as the time from enrollment to the first documented progression of disease or death due to any cause. Progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. KaplanMeier estimate was used for analysis.
Time frame: From enrollment until disease progression or death, assessed up to 24 months
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab | Progression-Free Survival (PFS) Assessed Using Local Standards | NA months |
Secondary
Time to Progression (TTP) Assessed Using Local Standards
TTP is defined as the time from enrollment to the PD. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan-Meier estimate was used for analysis.
Time frame: From enrollment until disease progression or death, assessed up to 26 months
Population: ITT population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rituximab | Time to Progression (TTP) Assessed Using Local Standards | NA months |