A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.

Roche

Status and phase: Terminated; Phase 2

Conditions: Diffuse Large B-Cell Lymphoma

Treatments: Drug: Fludarabine; Drug: Mitoxantrone; Drug: Cyclophosphamide; Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01144403

ML22489

2009-011433-27

Details and patient eligibility

About

This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Participants will receive MabThera (372 mg/m^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In participants experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult participants, >/=18 years of age
• untreated Mantle Cell Lymphoma, not eligible for Autologous Stem Cell Transplantation
• known mantle cell lymphoma international prognostic index (MIPI) at diagnosis
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• adequate hematological, renal and hepatic function

Exclusion criteria

• known hypersensitivity to murine proteins or chemotherapy regimen
• previous first-line therapy
• history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
• active infection
• clinically significant cardiac disease
• regular corticosteroid treatment in the 4 weeks prior to first dose of study drug

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Rituximab

Experimental group

Description:

Rituximab, 375 milligram per meter square (mg/m\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).

Treatment:

Drug: Fludarabine

Drug: Mitoxantrone

Drug: Cyclophosphamide

Drug: Rituximab