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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
History of Changes
  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:

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 543
Study Start Date: September 2006
Study Completion Date: September 2012
Primary Completion Date: September 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430352

  Show 176 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00430352     History of Changes
Other Study ID Numbers: MO19872
Study First Received: January 31, 2007
Last Updated: January 14, 2013
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on June 18, 2013