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

Phase 2TerminatedNCT01144403

Hoffmann-La Roche8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

Cyclophosphamide

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Brasov, Romania

Unnamed facility

Bucharest, Romania

Unnamed facility

Bucharest, Romania

Unnamed facility

Bucharest, Romania

Unnamed facility

Cluj-Napoca, Romania

Unnamed facility

Iași, Romania

Unnamed facility

Târgu Mureş, Romania

Unnamed facility

Timișoara, Romania

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites.

Time frame: Up to 50 months (approximately)

Secondary Outcomes

Overall Survival (OS)

Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death.

Time frame: From the time of enrollment until death due to any cause (up to 50 months [approximately])

Progression-free Survival (PFS)

PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.

Time frame: From the time of enrollment until death due to any cause (up to 50 months [approximately])

Number of Participant With Adverse Event (AE)

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.

Time frame: Up to 50 months (approximately)