This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
545
375mg/m2 iv every 8 weeks
Percentage of Participants With an Adverse Event (AE) - Overall Summary
Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.
Time frame: 24 months
Progression-Free Survival - Percentage of Participants With an Event
PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.
Time frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Progression-Free Survival - Time to Event
PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.
Time frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Event-Free Survival (EFS) - Percentage of Participants With an Event
The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.
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University "Mother Theresa" Hospital Center; Oncology Department
Tirana, Albania
Instituo Lavalle de Oncologia; Hematology
Bahía Blanca, Argentina
Academia Nacional de Medicina; Inst. de Cardiologia
Buenos Aires, Argentina
Fundaleu; Haematology
Buenos Aires, Argentina
Hospital Churruca Visca; Haematology
Buenos Aires, Argentina
Hospital Jr Vidal; Jefe de Servicio de Clinica Medica/Hematologia
Corrientes, Argentina
Sanatorio Allende; Haematology
Córdoba, Argentina
HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología
Córdoba, Argentina
Hospital General San Martin; Haematology
La Plata, Argentina
Liverpool Hospital; Haematology
Liverpool, New South Wales, Australia
...and 168 more locations
Time frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Event-Free Survival (EFS) - Time to Event
EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.
Time frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Overall Survival (OS) - Percentage of Participants With an Event
As a measure of overall survival (OS), the percentage of participants who died over the study period of 2 years with 1 year of follow-up. OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.
Time frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Overall Survival (OS) - Time to Event
OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.
Time frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event
As a measure of time to NLT (TNLT), the percentage of participants with new lymphoma treatment over a study period of 2 years with 1 year of follow-up. TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.
Time frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Time to NLT - Time to Event
TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.
Time frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Percentage of Participants With Response by Best Response to Study Treatment
Percentage of participants with complete response (CR), unconfirmed CR (CRu), no change, or progressive disease (PD). For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Where possible, assessment of response was based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma (NHL).
Time frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Percentage of Participants With PR Who Converted to CRu
Percentage of participants with PR or CR(u) conversion while on rituximab maintenance therapy over a study period of 2 years with 1 year of follow-up. For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Assessment and definition of response was based on the International Workshop to Standardize Response Criteria for NHL.
Time frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose