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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01144403
First received: June 14, 2010
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma, B-Cell
Drug: rituximab [Mabthera/Rituxan]
Drug: fludarabine
Drug: cyclophosphamide
Drug: mitoxantrone
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:
  • Overall Survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • 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 ]

Enrollment: 8
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: rituximab [Mabthera/Rituxan]
375 mg/m2 intravenously, day 1 of each 28-day cycle, up to 8 cycles
Drug: fludarabine
as prescribed, 6 cycles
Drug: cyclophosphamide
as prescribed, 6 cycles
Drug: mitoxantrone
as prescribed, 6 cycles

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144403

Locations
Romania
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01144403     History of Changes
Other Study ID Numbers: ML22489, 2009-011433-27
Study First Received: June 14, 2010
Last Updated: December 3, 2013
Health Authority: Romania: National Medicines Agency

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Fludarabine monophosphate
Rituximab
Fludarabine
Mitoxantrone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014