A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01144364
First received: June 11, 2010
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: rituximab [Mabthera/Rituxan]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study of MabThera Maintenance Therapy Compared With no Further Therapy After a Brief Induction With Chemotherapy Plus MabThera on Failure-free Survival in Treatment-naïve Elderly Patients With Advanced Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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

Secondary Outcome Measures:
  • Overall survival, progression-free survival, response rate and duration of response. Incidence of serious and life-threatening AEs \n [ Time Frame: From first patient enrolled to approximately 42 months ] [ Designated as safety issue: No ]

Enrollment: 234
Study Start Date: January 2004
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [Mabthera/Rituxan]
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients 60-75 years of age;
  • B-cell follicular NHL;
  • no previous treatment;
  • active disease, with rapid progression.

Exclusion Criteria:

  • other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast treated with lumpectomy;
  • long-term use (>1 month) of systemic corticosteroids;
  • central nervous system involvement;
  • history of significant cardiovascular disease;
  • positive test result for HIV, or hepatitis B or C.
  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 ClinicalTrials.gov identifier: NCT01144364

Locations
Italy
Alessandria, Italy, 15100
Ancona, Italy, 60020
Bari, Italy, 70124
Bergamo, Italy, 24127
Biella, Italy, 13051
Bologna, Italy, 40138
Bolzano, Italy, 39100
Brescia, Italy, 25123
Cagliari, Italy, 09121
Candiolo, Italy, 10060
Catania, Italy, 95124
Cremona, Italy, 26100
Cuneo, Italy, 12100
Firenze, Italy, 50135
Messina, Italy, 98165
Milano, Italy, 20122
Milano, Italy, 20162
Milano, Italy, 20133
Modena, Italy, 41100
Monza, Italy, 20052
Napoli, Italy, 80131
Nocera Inferiore, Italy, 84014
Orbassano, Italy, 10043
Palermo, Italy, 90146
Perugia, Italy, 06126
Pesaro, Italy, 61100
Pescara, Italy, 65100
Piacenza, Italy, 29100
Pisa, Italy, 56100
Ravenna, Italy, 48100
Reggio Calabria, Italy, 89100
Reggio Emilia, Italy, 42100
Roma, Italy, 00161
Roma, Italy, 00144
Roma, Italy, 00168
San Giovanni Rotondo, Italy, 71013
Torino, Italy, 10126
Udine, Italy, 33100
Venezia, Italy, 30122
Verona, Italy, 37130
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01144364     History of Changes
Other Study ID Numbers: ML17638
Study First Received: June 11, 2010
Last Updated: July 1, 2013
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014