Non-Hodgkin's Lymphoma
Conditions
Brief summary
This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Interventions
DRUGrituximab [Mabthera/Rituxan]
Intravenous repeating dose
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* adult patients 60-75 years of age; * B-cell follicular NHL; * no previous treatment; * active disease, with rapid progression.
Exclusion criteria
* other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast treated with lumpectomy; * long-term use (\>1 month) of systemic corticosteroids; * central nervous system involvement; * history of significant cardiovascular disease; * positive test result for HIV, or hepatitis B or C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Disease Progression or Death | 12, 24, and 34 months | PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date. |
| PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months | 12, 24, and 34 months | PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months | 12, 24, and 36 months | DFS was defined for all participants who achieved a complete response (CR) or unconfirmed CR (CRu) at Month 3 or later, after the completion of induction phase and was measured from the time of randomization to the date of relapse or death as a result of lymphoma or acute toxicity of treatment. Participants without relapse were censored at their last assessment date. Estimates of DFS were made using Kaplan-Meier product-limit method. |
| Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months | 12, 24, and 34 months | OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method. |
| Overall Survival (OS) From Randomization - Percentage of Participants With Death | 12, 24, and 34 months | OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method. |
| Percentage of Participants With a Response During the Induction Phase | Months 1 to 8 | Participants without a response assessment (due to any reasons) were considered as non-responders. |
| Percentage of Participants With a Molecular Response in the Induction Phase | Months 5 and 8 | Molecular responders were defined as the proportion of CR/CRu participants with a positive bcl-2/IgH (non-Hodgkin's Lymphoma \[NHL\] marker) at baseline, whose laboratory values were undetectable after treatment. |
| Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months | Months 12, 24, and 34 | Duration of response (DOR) was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of follicular lymphoma (FL). Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the traditional approach, duration of response was estimated as the proportion of participants alive without progression or relapse of disease with the Kaplan-Meier method. |
| Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months | Months 12, 24, and 34 | DOR was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of FL. Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the competing risk approach, deaths for causes other than FL were considered as competing events. DOR was estimated with the cumulative incidence of progression, relapse, or death as a result of FL. |
| OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months | 12, 24, and 36 months | OS from enrollment was defined as the date of enrollment to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method. |
| Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months | 12, 24, and 36 months | PFS from enrollment was measured from the date of enrollment to the date of disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. Estimates of PFS function were made with the Kaplan-Meier product-limit method. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m\^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses. | 101 |
| Rituximab Induction, Observation Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m\^2 IV on Day 1, fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m\^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m\^2 IV on Day 1, mitoxantrone 10 mg/m\^2 IV on Day 2, and fludarabine 25 mg/m\^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m\^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only. | 101 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Follow-Up/Maintenance Phase | Adverse Event | 0 | 3 | 1 |
| Follow-Up/Maintenance Phase | Death | 0 | 2 | 0 |
| Follow-Up/Maintenance Phase | Disease progression | 0 | 23 | 29 |
| Follow-Up/Maintenance Phase | Lost to Follow-up | 0 | 1 | 4 |
| Follow-Up/Maintenance Phase | Physician Decision | 0 | 0 | 1 |
| Follow-Up/Maintenance Phase | Relapse | 0 | 5 | 5 |
| Follow-Up/Maintenance Phase | Withdrawal by Subject | 0 | 1 | 1 |
| Induction Phase | Adverse Event | 9 | 0 | 0 |
| Induction Phase | Death | 1 | 0 | 0 |
| Induction Phase | Disease progression | 14 | 0 | 0 |
| Induction Phase | Lost to Follow-up | 2 | 0 | 0 |
| Induction Phase | Physician Decision | 1 | 0 | 0 |
| Induction Phase | Protocol Violation | 1 | 0 | 0 |
| Induction Phase | Secondary neoplasia | 1 | 0 | 0 |
| Induction Phase | Stable disease | 2 | 0 | 0 |
| Induction Phase | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Rituximab Induction, Rituximab Maintenance | Rituximab Induction, Observation Maintenance | Total |
|---|---|---|---|
| Age, Continuous | 66 years | 65 years | 66 years |
| Sex: Female, Male Female | 64 Participants | 56 Participants | 120 Participants |
| Sex: Female, Male Male | 37 Participants | 45 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 230 / 233 | 73 / 101 | 55 / 101 |
| serious Total, serious adverse events | 19 / 233 | 19 / 101 | 17 / 101 |
Outcome results
Primary
Percentage of Participants With Disease Progression or Death
PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date.
Time frame: 12, 24, and 34 months
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab Induction, Rituximab Maintenance | Percentage of Participants With Disease Progression or Death | 29.7 percentage of participants |
| Rituximab Induction, Observation Maintenance | Percentage of Participants With Disease Progression or Death | 34.7 percentage of participants |
Comparison: Difference between treatment armsp-value: 0.254Log Rank
Primary
PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months
PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods.
Time frame: 12, 24, and 34 months
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab Induction, Rituximab Maintenance | PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months | 12 months | 92.0 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months | 24 months | 81.0 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months | 34 months | 70.4 percentage of participants |
| Rituximab Induction, Observation Maintenance | PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months | 12 months | 82.5 percentage of participants |
| Rituximab Induction, Observation Maintenance | PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months | 24 months | 68.9 percentage of participants |
| Rituximab Induction, Observation Maintenance | PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months | 34 months | 62.3 percentage of participants |
Comparison: Analysis of overall PFS with Cox proportional-hazards model adjusted for the randomization stratum and the known prognostic factors.p-value: 0.07995% CI: [0.38, 1.05]Cox proportional-hazards
Secondary
Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months
DFS was defined for all participants who achieved a complete response (CR) or unconfirmed CR (CRu) at Month 3 or later, after the completion of induction phase and was measured from the time of randomization to the date of relapse or death as a result of lymphoma or acute toxicity of treatment. Participants without relapse were censored at their last assessment date. Estimates of DFS were made using Kaplan-Meier product-limit method.
Time frame: 12, 24, and 36 months
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab Induction, Rituximab Maintenance | Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months | 12 months | 93.0 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months | 24 months | 82.7 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months | 36 months | 69.2 percentage of participants |
| Rituximab Induction, Observation Maintenance | Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months | 12 months | 82.5 percentage of participants |
| Rituximab Induction, Observation Maintenance | Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months | 24 months | 68.9 percentage of participants |
| Rituximab Induction, Observation Maintenance | Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months | 36 months | 62.3 percentage of participants |
p-value: 0.10595% CI: [0.31, 1.12]Cox proportional-hazards
Secondary
Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months
Duration of response (DOR) was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of follicular lymphoma (FL). Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the traditional approach, duration of response was estimated as the proportion of participants alive without progression or relapse of disease with the Kaplan-Meier method.
Time frame: Months 12, 24, and 34
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab Induction, Rituximab Maintenance | Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months | 12 Months | 93.9 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months | 24 Months | 83.6 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months | 34 Months | 69.9 percentage of participants |
| Rituximab Induction, Observation Maintenance | Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months | 24 Months | 68.6 percentage of participants |
| Rituximab Induction, Observation Maintenance | Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months | 12 Months | 82.3 percentage of participants |
| Rituximab Induction, Observation Maintenance | Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months | 34 Months | 61.9 percentage of participants |
p-value: 0.10395% CI: [0.4, 1.09]Regression, Cox
p-value: 0.07195% CI: [0.37, 1.04]Regression, Cox
Secondary
Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months
DOR was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of FL. Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the competing risk approach, deaths for causes other than FL were considered as competing events. DOR was estimated with the cumulative incidence of progression, relapse, or death as a result of FL.
Time frame: Months 12, 24, and 34
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab Induction, Rituximab Maintenance | Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months | 12 Months | 6.1 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months | 24 Months | 16.2 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months | 34 Months | 29.5 percentage of participants |
| Rituximab Induction, Observation Maintenance | Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months | 12 Months | 17.7 percentage of participants |
| Rituximab Induction, Observation Maintenance | Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months | 24 Months | 31.4 percentage of participants |
| Rituximab Induction, Observation Maintenance | Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months | 34 Months | 38.0 percentage of participants |
p-value: 0.08495% CI: [0.39, 1.06]Fine and Gray model
p-value: 0.05295% CI: [0.38, 1]Fine and Gray model
Secondary
OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months
OS from enrollment was defined as the date of enrollment to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.
Time frame: 12, 24, and 36 months
Population: IP population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab Induction, Rituximab Maintenance | OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months | 24 months | 92.7 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months | 12 months | 94.9 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months | 36 months | 89.5 percentage of participants |
Secondary
Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months
OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.
Time frame: 12, 24, and 34 months
Population: ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab Induction, Rituximab Maintenance | Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months | 12 months | 97.0 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months | 24 months | 96.0 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months | 34 months | 96.0 percentage of participants |
| Rituximab Induction, Observation Maintenance | Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months | 12 months | 100 percentage of participants |
| Rituximab Induction, Observation Maintenance | Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months | 24 months | 96.9 percentage of participants |
| Rituximab Induction, Observation Maintenance | Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months | 34 months | 95.8 percentage of participants |
p-value: 0.751Log Rank
Secondary
Overall Survival (OS) From Randomization - Percentage of Participants With Death
OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.
Time frame: 12, 24, and 34 months
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab Induction, Rituximab Maintenance | Overall Survival (OS) From Randomization - Percentage of Participants With Death | 5.0 percentage of participants |
| Rituximab Induction, Observation Maintenance | Overall Survival (OS) From Randomization - Percentage of Participants With Death | 4.0 percentage of participants |
p-value: 0.751Log Rank
Secondary
Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months
PFS from enrollment was measured from the date of enrollment to the date of disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. Estimates of PFS function were made with the Kaplan-Meier product-limit method.
Time frame: 12, 24, and 36 months
Population: IP population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab Induction, Rituximab Maintenance | Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months | 12 months | 90.1 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months | 24 months | 77.8 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months | 36 months | 65.7 percentage of participants |
Secondary
Percentage of Participants With a Molecular Response in the Induction Phase
Molecular responders were defined as the proportion of CR/CRu participants with a positive bcl-2/IgH (non-Hodgkin's Lymphoma \[NHL\] marker) at baseline, whose laboratory values were undetectable after treatment.
Time frame: Months 5 and 8
Population: IP population; only participants with a positive bcl-2/IgH (NHL marker) at baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab Induction, Rituximab Maintenance | Percentage of Participants With a Molecular Response in the Induction Phase | Month 5 | 36.4 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Percentage of Participants With a Molecular Response in the Induction Phase | Month 8 | 58.5 percentage of participants |
Secondary
Percentage of Participants With a Response During the Induction Phase
Participants without a response assessment (due to any reasons) were considered as non-responders.
Time frame: Months 1 to 8
Population: ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab Induction, Rituximab Maintenance | Percentage of Participants With a Response During the Induction Phase | Partial remission | 19.8 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Percentage of Participants With a Response During the Induction Phase | Complete remission (CR/CRu) | 79.2 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Percentage of Participants With a Response During the Induction Phase | Stable disease | 1.0 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Percentage of Participants With a Response During the Induction Phase | Progression disease | 0.0 percentage of participants |
| Rituximab Induction, Rituximab Maintenance | Percentage of Participants With a Response During the Induction Phase | Missing | 0.0 percentage of participants |
| Rituximab Induction, Observation Maintenance | Percentage of Participants With a Response During the Induction Phase | Progression disease | 0.0 percentage of participants |
| Rituximab Induction, Observation Maintenance | Percentage of Participants With a Response During the Induction Phase | Stable disease | 0.0 percentage of participants |
| Rituximab Induction, Observation Maintenance | Percentage of Participants With a Response During the Induction Phase | Missing | 1.0 percentage of participants |
| Rituximab Induction, Observation Maintenance | Percentage of Participants With a Response During the Induction Phase | Complete remission (CR/CRu) | 79.2 percentage of participants |
| Rituximab Induction, Observation Maintenance | Percentage of Participants With a Response During the Induction Phase | Partial remission | 19.8 percentage of participants |