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

Tracking Information

First Received Date ^ICMJE

January 31, 2007

Last Updated Date

November 17, 2009

Start Date ^ICMJE

September 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Incidence of all, and of grade 3/4, adverse events. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

PFS, event free survival, overall survival, time to next lymphoma treatment, PR to CR conversion rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Progression-free survival, event free survival, overall survival, time to next lymphoma treatment, PR to CR conversion rate.

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Non-Hodgkin's Lymphoma

Intervention ^ICMJE

Drug: rituximab [MabThera/Rituxan]

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

March 2011

Primary Completion Date

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Albania, Argentina, Australia, Bosnia and Herzegovina, Brazil, Bulgaria, Colombia, Croatia, Ecuador, Egypt, Finland, Germany, Greece, Israel, Italy, Mexico, Romania, Russian Federation, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey

Administrative Information

NCT ID ^ICMJE

NCT00430352

Responsible Party

Disclosures Group, Hoffmann-La Roche

Study ID Numbers ^ICMJE

MO19872

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

November 2009

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