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

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

This study is currently recruiting participants.
Verified by Hoffmann-La Roche, April 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00430352

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 IV

MedlinePlus related topics:

Lymphoma

ChemIDplus related topics:

Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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.

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 ]

Estimated Enrollment:	500
Study Start Date:	September 2006
Estimated Study Completion Date:	October 2011

Arms	Assigned Interventions
1: Experimental	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

Contacts


Contact: Please reference Study ID Number: PDO_MO19872	973-235-5000

Contact: or	800-526-6367 (FOR US ONLY)

Show 173 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	MO19872
First Received:	January 31, 2007
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00430352
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Lymphatic Diseases

Immunoproliferative Disorders

Rituximab

Lymphoma, small cleaved-cell, diffuse

Lymphoma, Follicular

Lymphoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphoma

Follicular lymphoma

Additional relevant MeSH terms:

Neoplasms

Hemic and Lymphatic Diseases

Neoplasms by Histologic Type

Immunologic Factors

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Antirheumatic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on May 14, 2008