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

NCT ID: NCT01144403

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-08-31

Brief Summary

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.

Conditions

Diffuse Large B-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab

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).

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

as prescribed, 6 cycles

Fludarabine

Intervention Type: DRUG

as prescribed, 6 cycles

Mitoxantrone

Intervention Type: DRUG

as prescribed, 6 cycles

Rituximab

Intervention Type: DRUG

375 mg/m\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles

Interventions

Cyclophosphamide

as prescribed, 6 cycles

Intervention Type: DRUG

Fludarabine

as prescribed, 6 cycles

Intervention Type: DRUG

Mitoxantrone

as prescribed, 6 cycles

Intervention Type: DRUG

Rituximab

375 mg/m\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles

Intervention Type: DRUG

Other Intervention Names

Mabthera/Rituxan

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Brasov, , Romania

Bucharest, , Romania

Bucharest, , Romania

Bucharest, , Romania

Cluj-Napoca, , Romania

Iași, , Romania

Târgu Mureş, , Romania

Timișoara, , Romania

Countries

Romania

Other Identifiers

2009-011433-27

Identifier Type: -

Identifier Source: secondary_id

ML22489

Identifier Type: -

Identifier Source: org_study_id