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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: June 14, 2010
Last updated: October 13, 2014
Last verified: October 2014

This multicenter, open-label study will assess the efficacy and safety of MabThe ra (rituximab) added to standard chemotherapy in patients with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Patients wi ll 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 experiencin g complete or partial response, MabThera will be continued as consolidation ther apy for 2 more cycles. Anticipated time on study treatment is 6 to 8 months.

Condition Intervention Phase
Lymphoma, B-Cell
Drug: cyclophosphamide
Drug: fludarabine
Drug: mitoxantrone
Drug: rituximab [Mabthera/Rituxan]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Open-label Study of MabThera(Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall Response Rate (ORR), according to International Working Group (IWG) criteria, assessed by computed tomography (CT) or magnetic resonance imaging (MRI) [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival, according to IWG criteria, assessed by CT or MRI [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Safety and tolerability: Adverse events. laboratory parameters [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: June 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: cyclophosphamide
as prescribed, 6 cycles
Drug: fludarabine
as prescribed, 6 cycles
Drug: mitoxantrone
as prescribed, 6 cycles
Drug: rituximab [Mabthera/Rituxan]
375 mg/m2 intravenously, day 1 of each 28-day cycle, up to 8 cycles


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01144403

Brasov, Romania, 500326
Bucharest, Romania, 022328
Bucharest, Romania, 005098
Bucuresti, Romania, 030171
Cluj-Napoca, Romania, 400015
Iasi, Romania, 700111
Targu-mures, Romania, 540136
Timisoara, Romania, 300079
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01144403     History of Changes
Other Study ID Numbers: ML22489, 2009-011433-27
Study First Received: June 14, 2010
Last Updated: October 13, 2014
Health Authority: Romania: National Medicines Agency

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Topoisomerase II Inhibitors processed this record on November 20, 2014