MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
- Registration Number
- NCT00430352
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 545
- adult patients, >=18 years of age;
- histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;
- patients who have received adequate (>=8 cycles) induction therapy with MabThera as first line treatment, or treatment for relapsed disease;
- demonstrated partial or complete response to induction therapy.
- stable or progressive disease after most recent induction therapy;
- transformation to high grade lymphoma;
- patients with prior or concomitant malignancies, except non-melanoma skin cancer or adequately treated in situ cancer of the cervix.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 rituximab [MabThera/Rituxan] -
- Primary Outcome Measures
Name Time Method Percentage of Participants With an Adverse Event (AE) - Overall Summary 24 months 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.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) - Time to Event Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose 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.
Progression-Free Survival - Percentage of Participants With an Event Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose 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.
Progression-Free Survival - Time to Event Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose 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.
Event-Free Survival (EFS) - Percentage of Participants With an Event Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose 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.
Event-Free Survival (EFS) - Time to Event Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose 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.
Overall Survival (OS) - Percentage of Participants With an Event Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose 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 to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose 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 to NLT - Time to Event Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose 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.
Percentage of Participants With Response by Best Response to Study Treatment Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose 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).
Percentage of Participants With PR Who Converted to CRu Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose 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.
Trial Locations
- Locations (177)
University "Mother Theresa" Hospital Center; Oncology Department
🇦🇱Tirana, Albania
Instituo Lavalle de Oncologia; Hematology
🇦🇷Bahia 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
Scroll for more (167 remaining)University "Mother Theresa" Hospital Center; Oncology Department🇦🇱Tirana, Albania