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A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01153971
First received: June 14, 2010
Last updated: April 18, 2011
Last verified: April 2011
History of Changes
  Purpose

This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
 Drug: rituximab
 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 Fludarabine and Cyclophosphamide Plus MabThera Followed by Maintenance With MabThera on Failure-free Survival in Treatment-naïve Patients With Advanced Indolent B-cell Nonfollicular Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Failure-free survival [ Time Frame: From first patient enrolled to approximately 42 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From first patient enrolled to approximately 42 months ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: From first patient enrolled to approximately 42 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: From first patient enrolled to approximately 42 months ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: From first patient enrolled to approximately 42 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: From first patient enrolled to approximately 42 months ] [ Designated as safety issue: No ]

Enrollment: 47
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab
1
Other Name: MabThera/Rituxan

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients 18-65 years of age;
  • previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
  • active disease;
  • >=3 involved sites.

Exclusion Criteria:

  • typical chronic lymphocytic leukemia;
  • other malignancies within 3 years before study, except basal or squamous cell skin cancer or cancer in situ of the cervix;
  • systemic corticosteroid use for >1 month;
  • significant cardiovascular disease;
  • central nervous system involvement;
  • hepatitis B or C virus infection, or HIV infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153971

Locations
Italy
Alessandria, Italy, 15100
Brescia, Italy, 25123
Cuneo, Italy, 12100
Firenze, Italy, 50135
Messina, Italy, 98165
Milano, Italy, 20162
Milano, Italy, 20122
Modena, Italy, 41100
Pescara, Italy, 65124
Pescara, Italy, 65100
Reggio Calabria, Italy, 89100
Reggio Emilia, Italy, 42100
Rionero in Vulture, Italy, 85028
Roma, Italy, 00161
Torino, Italy, 10126
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01153971     History of Changes
Other Study ID Numbers: ML18324
Study First Received: June 14, 2010
Last Updated: April 18, 2011
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013