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

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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:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE January 31, 2007
First Posted Date  ICMJE February 1, 2007
Results First Submitted Date  ICMJE September 4, 2014
Results First Posted Date  ICMJE June 8, 2015
Last Update Posted Date August 14, 2017
Actual Study Start Date  ICMJE September 4, 2006
Actual Primary Completion Date May 26, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Hodgkin's Lymphoma
Intervention  ICMJE Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv every 8 weeks
Study Arms  ICMJE 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2015)
545
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 26, 2011
Actual Primary Completion Date May 26, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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  ICMJE NCT00430352
Other Study ID Numbers  ICMJE MO19872
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP