A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: May 10, 2007
Last updated: March 3, 2014
Last verified: March 2014

This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Condition Intervention Phase
Mantle Cell Lymphoma
Drug: rituximab [MabThera/Rituxan]
Drug: First line chemotherapy
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: An Open-label Study of the Effect of the Addition of MabThera to Standard Chemotherapy on Clinical Response in Patients With Previously Untreated Mantle Cell Lymphoma

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Complete and partial response [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event-free survival, progression-free survival, time to treatment failure. [ Time Frame: AEs, laboratory parameters. ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: June 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv every 3 weeks
Drug: First line chemotherapy
As prescribed


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

Inclusion Criteria:

  • histologically-proven mantle cell lymphoma;
  • previously untreated disease at stage II, III and IV, requiring therapy.

Exclusion Criteria:

  • known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies;
  • active malignancy other than mantle cell lymphoma within 5 years of start of study, with the exception of resected basal cell cancer, squamous cell cancer of the skin, or in situ cancer of the cervix;
  • serious disorders interfering with full standard dosing chemotherapy;
  • stage I disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00472420

Budapest, Hungary, 1122
Debrecen, Hungary, 4032
Gyor, Hungary, 9024
Kaposvar, Hungary, 7400
Miskolc, Hungary, 3529
Szeged, Hungary, 6720
Zalaegerszeg, Hungary, 8901
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00472420     History of Changes
Other Study ID Numbers: ML20493
Study First Received: May 10, 2007
Last Updated: March 3, 2014
Health Authority: Hungary: Ministry of Health

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 15, 2014