A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.

Roche

Status and phase: Completed; Phase 2

Conditions: Mantle Cell Lymphoma

Treatments: Drug: rituximab [MabThera/Rituxan]; Drug: First line chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00472420

ML20493

Details and patient eligibility

About

This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically-proven mantle cell lymphoma;
• previously untreated disease at stage II, III and IV, requiring therapy.

Exclusion criteria

• known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies;
• active malignancy other than mantle cell lymphoma within 5 years of start of study, with the exception of resected basal cell cancer, squamous cell cancer of the skin, or in situ cancer of the cervix;
• serious disorders interfering with full standard dosing chemotherapy;
• stage I disease.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

1

Experimental group

Treatment:

Drug: rituximab [MabThera/Rituxan]

Drug: First line chemotherapy