Trial Outcomes & Findings for Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A (NCT NCT02406092)

Last Updated: 2024-11-21

Results Overview

AARs defined as all related adverse events (AEs) occurring within 24 hours of rituximab SC administration, including infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

139 participants

Primary outcome timeframe

Within 24 hours of each rituximab SC administration (maximum treatment duration up to 32 months for FL participants and up to 8 months for DLBCL participants)

Results posted on

2024-11-21

Participant Flow

Total of 139 participants mentioned below in the table were recruited and enrolled.

139 participants (105 with DLBCL and 34 with FL) in the intent-to-treat (ITT) population; 122 participants (95 with DLBCL and 27 with FL) in the safety population. From 139 participants, 122 were dosed at least 1 dose were included in Safety Analysis Set.

Participant milestones

Participant milestones
Measure	DLBCL Arm Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	FL Arm Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.
Overall Study STARTED	105	34
Overall Study COMPLETED	67	21
Overall Study NOT COMPLETED	38	13

Reasons for withdrawal

Reasons for withdrawal
Measure	DLBCL Arm Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	FL Arm Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.
Overall Study Screen failure	10	7
Overall Study Death	22	5
Overall Study Lost to Follow-up	4	1
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DLBCL Arm n=105 Participants Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	FL Arm n=34 Participants Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	Total n=139 Participants Total of all reporting groups
Age, Continuous	51.3 Years STANDARD_DEVIATION 13.78 • n=5 Participants	52.8 Years STANDARD_DEVIATION 12.65 • n=7 Participants	51.7 Years STANDARD_DEVIATION 13.48 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	22 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	12 Participants n=7 Participants	61 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	15 Participants n=5 Participants	4 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	74 Participants n=5 Participants	24 Participants n=7 Participants	98 Participants n=5 Participants
Race/Ethnicity, Customized Not applicable as per local regulations	16 Participants n=5 Participants	6 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 24 hours of each rituximab SC administration (maximum treatment duration up to 32 months for FL participants and up to 8 months for DLBCL participants)

Population: Safety Population

Outcome measures

Outcome measures
Measure	DLBCL Arm n=95 Participants Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	FL Arm n=27 Participants Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	Overall Population n=122 Participants All participants will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.
Percentage of Participants With Administration-Associated Reactions (AARs) Skin And Subcutaneous Tissue Disorders, Dermatitis Allergic	1.1 Percentage of Participants %	0 Percentage of Participants %	0.8 Percentage of Participants %
Percentage of Participants With Administration-Associated Reactions (AARs) Blood And Lymphatic System Disorders, And Lymphatic System Disorders, Anaemia	1.1 Percentage of Participants %	3.7 Percentage of Participants %	1.6 Percentage of Participants %
Percentage of Participants With Administration-Associated Reactions (AARs) Blood And Lymphatic System Disorders, Leukopenia	1.1 Percentage of Participants %	0 Percentage of Participants %	0.8 Percentage of Participants %
Percentage of Participants With Administration-Associated Reactions (AARs) Blood And Lymphatic System Disorders, Thrombocytopenia	1.1 Percentage of Participants %	0 Percentage of Participants %	0.8 Percentage of Participants %
Percentage of Participants With Administration-Associated Reactions (AARs) General Disorders And Administration Site Conditions, Injection Site Erythema	4.2 Percentage of Participants %	7.4 Percentage of Participants %	4.9 Percentage of Participants %
Percentage of Participants With Administration-Associated Reactions (AARs) General Disorders And Administration Site Conditions, Injection Site, Injection Site Pain	4.2 Percentage of Participants %	0 Percentage of Participants %	3.3 Percentage of Participants %
Percentage of Participants With Administration-Associated Reactions (AARs) Nervous System Disorders, Burning Sensation	2.1 Percentage of Participants %	0 Percentage of Participants %	1.6 Percentage of Participants %
Percentage of Participants With Administration-Associated Reactions (AARs) Nervous System Disorders, Paraesthesia	1.1 Percentage of Participants %	0 Percentage of Participants %	0.8 Percentage of Participants %
Percentage of Participants With Administration-Associated Reactions (AARs) Skin And Subcutaneous Tissue Disorders, Erythema	2.1 Percentage of Participants %	0 Percentage of Participants %	1.6 Percentage of Participants %

SECONDARY outcome

Timeframe: From first dose of rituximab intravenous (IV) and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])

Population: ITT

EFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to first occurrence of progression or relapse, according to the IWG response criteria or other country standards, or initiation of a non-protocolspecified anti-lymphoma therapy or death, whichever occurs first.

Outcome measures

Outcome measures
Measure	DLBCL Arm n=105 Participants Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	FL Arm n=34 Participants Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	Overall Population n=139 Participants All participants will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.
Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria From first dose of rituximab IV	NA Months Interval 33.4 to The median and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.	53.8 Months Interval 32.6 to The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.	53.8 Months Interval 38.4 to The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.
Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria From first dose of rituximab SC	NA Months Interval 32.7 to The median and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.	45.5 Months Interval 25.1 to The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events	45.5 Months Interval 33.5 to The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events

SECONDARY outcome

Timeframe: From first dose of rituximab IV and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months])

Population: ITT

PFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to the first occurrence of progression or relapse, according to the IWG response criteria (Cheson et al. 1999) or other country standards, or death from any cause.

Outcome measures

Outcome measures
Measure	DLBCL Arm n=95 Participants Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	FL Arm n=27 Participants Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	Overall Population n=122 Participants All participants will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.
Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria From first dose of rituximab IV	NA Months Interval 33.4 to The median and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.	53.8 Months Interval 32.6 to The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.	53.8 Months Interval 38.4 to The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.
Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria From first dose of rituximab SC	NA Months Interval 32.7 to The median and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.	45.5 Months Interval 25.1 to The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.	44.5 Months Interval 35.5 to The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [Up to 51.1 Months])

Population: ITT

OS is defined as the time from first dose of rirtuximab (analysed using both first dose of IV and first dose of SC) until death from any cause.

Outcome measures

Outcome measures
Measure	DLBCL Arm n=95 Participants Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	FL Arm n=27 Participants Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	Overall Population n=122 Participants All participants will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.
Overall Survival (OS) From first dose of rituximab IV	51.4 Months Interval 50.4 to The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.	NA Months The median, lower, and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.	NA Months The median, lower, and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.
Overall Survival (OS) From first dose of rituximab SC	51.4 Months Interval 50.4 to The upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.	NA Months The median, lower, and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.	NA Months The median, lower, and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: From the date of the initial complete response (CR)/complete response unconfirmed (CRu) until date of relapse or death from any cause (up to end of induction treatment [Up to 32.7 Months])

Population: ITT

DFS will be assessed at the end of induction treatment in patients achieving CR/CRu and is defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause.

Outcome measures

Outcome measures
Measure	DLBCL Arm n=95 Participants Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	FL Arm n=27 Participants Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	Overall Population n=122 Participants All participants will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.
Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria	NA Months The median, lower, and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.	NA Months Interval 19.7 to The median and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.	NA Months Interval 32.7 to The median and upper limit of 95% CI was not evaluable due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: From first dose of rituximab until first occurrence of progression or relapse (up to end of induction treatment [Up to 32 Months])

Population: ITT

CR/CRu: Response assessments 4 - 6 weeks after the last dose of induction treatment will be based on the Investigator's assessment, completed according to the original International Working Group (IWG) response criteria for response assessment of lymphoma (Cheson et al. 1999).

Outcome measures

Outcome measures
Measure	DLBCL Arm n=95 Participants Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	FL Arm n=27 Participants Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	Overall Population n=122 Participants All participants will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.
Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria	74.2 Percentage Interval 63.8 to 82.9	76.5 Percentage Interval 50.1 to 93.2	74.5 Percentage Interval 65.1 to 82.5

SECONDARY outcome

Timeframe: End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants)

Planned Healthcare Professional Questionnaiere was not collected during the study therefore no data to report

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 53.8 Months

Population: Safety Population

The RASQ measures the overall participant satisfaction and is a 20-item questionnaire measuring the impact of the treatment administration on 5 domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. Each question's answer is chosen from 1 (minimum)-5(maximum score indicating less severity) score range. For each domain was scored using the following formula: Domain score = \[(Sum of completed item (question) responses / Number of completed items) - 1\] x 100 / (Maximum possible item response value - Minimum possible item response value) The final RASQ domains is calculated using the formula: RASQ domain score = (Mean of completed item responses - 1) x 25, scores ranging from 1-100 with higher scores indicative of more positive feelings toward therapy. Lower number representing lower satisfaction and higher is the higher satisfaction by the participants.

Outcome measures

Outcome measures
Measure	DLBCL Arm n=95 Participants Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	FL Arm n=27 Participants Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	Overall Population n=122 Participants All participants will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.
Patient-Reported Rituximab Administration Questionnaire (RASQ) Score	70.5 Scores on a Scale Standard Deviation 20.76	69.2 Scores on a Scale Standard Deviation 19.83	70.2 Scores on a Scale Standard Deviation 20.48

Adverse Events

DLBCL Arm

Serious events: 11 serious events

Other events: 58 other events

Deaths: 22 deaths

FL Arm

Serious events: 8 serious events

Other events: 12 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	DLBCL Arm n=95 participants at risk Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	FL Arm n=27 participants at risk Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.
Blood and lymphatic system disorders Neutropenia	43.2% 41/95 • Number of events 91 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	25.9% 7/27 • Number of events 13 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Blood and lymphatic system disorders Anaemia	13.7% 13/95 • Number of events 24 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	14.8% 4/27 • Number of events 8 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Blood and lymphatic system disorders Leukopenia	10.5% 10/95 • Number of events 13 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	3.7% 1/27 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Blood and lymphatic system disorders Thrombocytopenia	9.5% 9/95 • Number of events 14 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	7.4% 2/27 • Number of events 3 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Gastrointestinal disorders Diarrhoea	8.4% 8/95 • Number of events 9 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
General disorders Mucosal Inflammation	10.5% 10/95 • Number of events 12 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	7.4% 2/27 • Number of events 2 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
General disorders Injection Site Erythema	5.3% 5/95 • Number of events 5 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	7.4% 2/27 • Number of events 2 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
General disorders Pyrexia	5.3% 5/95 • Number of events 5 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	3.7% 1/27 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Infections and infestations Oral Herpes	5.3% 5/95 • Number of events 6 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Investigations Aspartate Aminotransferase Increased	0.00% 0/95 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	7.4% 2/27 • Number of events 2 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Nervous system disorders Paraesthesia	14.7% 14/95 • Number of events 15 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	18.5% 5/27 • Number of events 5 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Respiratory, thoracic and mediastinal disorders Cough	6.3% 6/95 • Number of events 6 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	7.4% 2/27 • Number of events 2 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])

Additional Information

Medical Communications

Hoffman-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
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Restriction type: OTHER

Measure	DLBCL Arm n=95 participants at risk Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.	FL Arm n=27 participants at risk Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP \[cyclophosphamide+doxorubicin+vincristine+prednisone\], CVP \[cyclophosphamide+vincristine+prednisone\] or FC \[fludarabine+cyclophosphamide\]) during induction.
Metabolism and nutrition disorders Dehydration	1.1% 1/95 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Generalised Tonic-Clonic Seizure	0.00% 0/95 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	3.7% 1/27 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Nervous system disorders Haemorrhagic Stroke	1.1% 1/95 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Vascular disorders Deep Vein Thrombosis	1.1% 1/95 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Vascular disorders Hypertension	1.1% 1/95 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Blood and lymphatic system disorders Febrile Neutropenia	1.1% 1/95 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	7.4% 2/27 • Number of events 2 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Blood and lymphatic system disorders Neutropenia	2.1% 2/95 • Number of events 2 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Blood and lymphatic system disorders Bone Marrow Failure	1.1% 1/95 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Blood and lymphatic system disorders Thrombocytopenia	1.1% 1/95 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Cardiac disorders Cardiac Failure Acute	0.00% 0/95 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	3.7% 1/27 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Endocrine disorders Goitre	0.00% 0/95 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	3.7% 1/27 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Gastrointestinal disorders Rectal Haemorrhage	1.1% 1/95 • Number of events 2 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
General disorders Death	2.1% 2/95 • Number of events 2 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	3.7% 1/27 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
General disorders Mucosal Inflammation	2.1% 2/95 • Number of events 4 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Infections and infestations Abscess Limb	0.00% 0/95 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	3.7% 1/27 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Infections and infestations Candida Infection	0.00% 0/95 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	3.7% 1/27 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Infections and infestations Hepatitis B Reactivation	1.1% 1/95 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Infections and infestations Klebsiella Bacteraemia	0.00% 0/95 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	3.7% 1/27 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Infections and infestations Pneumonia	1.1% 1/95 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Infections and infestations Septic Shock	0.00% 0/95 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	3.7% 1/27 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Injury, poisoning and procedural complications Fibula Fracture	0.00% 0/95 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	3.7% 1/27 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Investigations Liver Function Test Abnormal	0.00% 0/95 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	3.7% 1/27 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
Metabolism and nutrition disorders Decreased Appetite	1.1% 1/95 • Number of events 1 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])	0.00% 0/27 • From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])