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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00430352
First received: January 31, 2007
Last updated: June 3, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: rituximab [MabThera/Rituxan]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With an Adverse Event (AE) - Overall Summary [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 545
Study Start Date: September 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv every 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430352

  Show 177 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00430352     History of Changes
Other Study ID Numbers: MO19872
Study First Received: January 31, 2007
Results First Received: September 4, 2014
Last Updated: June 3, 2015
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015