This multi-center, open-label, randomized study will evaluate the participant preference with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV) on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4, followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8 cycles of standard chemotherapy (according to local country practice) with 8 cycles of MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
743
Standard chemotherapy
Standard chemotherapy
Standard chemotherapy
1400 mg subcutaneously (SC), Day 1 Cycles 2-4
375 mg/m2 IV, Day 1 Cycles 1-4
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
1400 mg SC, Day 1 Cycles 5-8
Unnamed facility
Buenos Aires, Argentina
Unnamed facility
Corrientes, Argentina
Unnamed facility
Santa Fé, Argentina
Unnamed facility
Canberra, Australian Capital Territory, Australia
Unnamed facility
Camperdown, New South Wales, Australia
Unnamed facility
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6.
Time frame: Cycle 6 (Up to 24 weeks)
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8
Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8.
Time frame: Cycle 8 (Up to 32 weeks)
Number of Participants With Treatment Emergent Adverse Events (AEs)
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Randomization of first participant to clinical cutoff date (Up to 4 years)
Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])
Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion
Time frame: Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)
Cancer Therapy Satisfaction Questionnaire (CTSQ) Score
CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.
Time frame: During Cycle 4, 8 of treatment (Up to 32 weeks)
Rituximab Administration Satisfaction Questionnaire (RASQ) Score
The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.
Time frame: During Cycle 4, 8 of treatment (Up to 32 weeks)
Complete Response (CR) Rate
CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by \> 75 % but still \>1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study.
Time frame: 28 days (± 3 days) after Day 1 of the last dose of induction treatment
Event-free Survival (EFS)
EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (\<=) 1.0 × \<= 1.0 cm would not be considered as abnormal for PD.
Time frame: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Disease-free Survival (DFS)
DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first.
Time frame: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Progression-free Survival (PFS)
PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes \<= 1.0 × \<= 1.0 cm would not be considered as abnormal for PD.
Time frame: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Overall Survival (OS)
OS was defined as the time from randomization to death from any cause.
Time frame: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Percentage of Participants With Anti-Rituximab Antibodies Over Time
Time frame: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
Time frame: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Summary of Observed Serum Rituximab Concentration
Time frame: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
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Liverpool, New South Wales, Australia
Unnamed facility
Randwick, New South Wales, Australia
Unnamed facility
Brisbane, Queensland, Australia
Unnamed facility
Adelaide, South Australia, Australia
Unnamed facility
Hobart, Tasmania, Australia
...and 236 more locations