MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.

• ClinicalTrials.gov Identifier: NCT00430352
• Recruitment Status: Completed
• First Posted: February 1, 2007
• Results First Posted: June 8, 2015
• Last Update Posted: August 14, 2017
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Tracking Information

• First Submitted Date: January 31, 2007
• First Posted Date: February 1, 2007
• Results First Submitted Date: September 4, 2014
• Results First Posted Date: June 8, 2015
• Last Update Posted Date: August 14, 2017
• Actual Study Start Date: September 4, 2006
• Actual Primary Completion Date: May 26, 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 3, 2015)

Percentage of Participants With an Adverse Event (AE) - Overall Summary [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: January 31, 2007): Incidence of all, and of grade 3/4, adverse events.
• Change History: Complete list of historical versions of study NCT00430352 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: June 3, 2015)

• Progression-Free Survival - Percentage of Participants With an Event [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
• Overall Survival (OS) - Time to Event [ Time Frame: 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.
• Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

• Original Secondary Outcome Measures (submitted: January 31, 2007): Progression-free survival, event free survival, overall survival, time to next lymphoma treatment, PR to CR conversion rate.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
• Official Title: A Study to Evaluate the Safety of MabThera (Rituximab) Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma Who Have Responded to Induction Therapy.
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Hodgkin's Lymphoma

Intervention

Drug: rituximab [MabThera/Rituxan]

375mg/m2 iv every 8 weeks

Study Arms

Experimental: 1

Intervention: Drug: rituximab [MabThera/Rituxan]

• Publications *: Witzens-Harig M, Foá R, Di Rocco A, van Hazel G, Chamone DF, Rowe JM, Arcaini L, Poddubnaya I, Ho AD, Ivanova V, Vranovsky A, Thurley D, Oertel S. Maintenance with rituximab is safe and not associated with severe or uncommon infections in patients with follicular lymphoma: results from the phase IIIb MAXIMA study. Ann Hematol. 2014 Oct;93(10):1717-24. doi: 10.1007/s00277-014-2103-3. Epub 2014 May 14. Erratum in: Ann Hematol. 2014 Oct;93(10):1807.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 3, 2015): 545
• Original Enrollment: Not Provided
• Actual Study Completion Date: May 26, 2011
• Actual Primary Completion Date: May 26, 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Bulgaria, Albania, Australia, Bosnia and Herzegovina, Brazil, Colombia, Croatia, Ecuador, Egypt, Finland, Germany, Greece, Israel, Italy, Mexico, Romania, Russian Federation, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey
• Removed Location Countries: Lithuania, United States

Administrative Information

• NCT Number: NCT00430352
• Other Study ID Numbers: MO19872
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Hoffmann-La Roche
• Study Sponsor: Hoffmann-La Roche
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: July 2017