A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

Roche

Status and phase: Completed; Phase 3

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: rituximab [Mabthera/Rituxan]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01144364

ML17638

Details and patient eligibility

About

This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Enrollment: 234 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients 60-75 years of age;
• B-cell follicular NHL;
• no previous treatment;
• active disease, with rapid progression.

Exclusion criteria

• other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast treated with lumpectomy;
• long-term use (>1 month) of systemic corticosteroids;
• central nervous system involvement;
• history of significant cardiovascular disease;
• positive test result for HIV, or hepatitis B or C.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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234 participants in 1 patient group

1

Experimental group

Treatment:

Drug: rituximab [Mabthera/Rituxan]