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

Diffuse Large B-Cell Lymphoma Clinical Trial

Official title:

A Phase II Multicenter Open-label Study of MabThera(Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01144403
• Other study ID #: ML22489
• Secondary ID: 2009-011433-27
• Status: Terminated
• Phase: Phase 2
• First received: June 14, 2010
• Last updated: May 4, 2016
• Start date: June 2010
• Est. completion date: August 2014

Study information

• Verified date: May 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in patients with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Patients will receive MabThera (372 mg/m2 intravenously) on day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In patients experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles. Anticipated time on study treatment is 6 to 8 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >/=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

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell

Intervention

Drug:
• cyclophosphamide
as prescribed, 6 cycles
• fludarabine
as prescribed, 6 cycles
• mitoxantrone
as prescribed, 6 cycles
• rituximab [Mabthera/Rituxan]
375 mg/m2 intravenously, day 1 of each 28-day cycle, up to 8 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR), according to International Working Group (IWG) criteria, assessed by computed tomography (CT) or magnetic resonance imaging (MRI)		approximately 2.5 years	No
Secondary	Progression-free survival, according to IWG criteria, assessed by CT or MRI		up to 5 years	No
Secondary	Safety and tolerability: Adverse events. laboratory parameters		up to 5 years	No
Secondary	Overall Survival		up to 5 years	No