Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: January 14, 2013
Last verified: January 2013

January 31, 2007
January 14, 2013
September 2006
September 2012   (final data collection date for primary outcome measure)
Incidence of all, and of grade 3/4, adverse events. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Incidence of all, and of grade 3/4, adverse events.
Complete list of historical versions of study NCT00430352 on ClinicalTrials.gov Archive Site
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 ]
Progression-free survival, event free survival, overall survival, time to next lymphoma treatment, PR to CR conversion rate.
Not Provided
Not Provided
 
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv every 8 weeks
Experimental: 1
Intervention: Drug: rituximab [MabThera/Rituxan]
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
543
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT00430352
MO19872
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2013

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