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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: December 3, 2014
Last verified: December 2014
  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:
  • Percentage of Participants With Disease Progression or Death [ Time Frame: 12, 24, and 34 months ] [ Designated as safety issue: No ]
    PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date.

  • PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months [ Time Frame: 12, 24, and 34 months ] [ Designated as safety issue: No ]
    PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods.


Secondary Outcome Measures:
  • Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months [ Time Frame: 12, 24, and 36 months ] [ Designated as safety issue: No ]
    PFS from enrollment was measured from the date of enrollment to the date of disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. Estimates of PFS function were made with the Kaplan-Meier product-limit method.

  • Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months [ Time Frame: 12, 24, and 36 months ] [ Designated as safety issue: No ]
    DFS was defined for all participants who achieved a complete response (CR) or unconfirmed CR (CRu) at Month 3 or later, after the completion of induction phase and was measured from the time of randomization to the date of relapse or death as a result of lymphoma or acute toxicity of treatment. Participants without relapse were censored at their last assessment date. Estimates of DFS were made using Kaplan-Meier product-limit method.

  • Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months [ Time Frame: 12, 24, and 34 months ] [ Designated as safety issue: No ]
    OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.

  • Overall Survival (OS) From Randomization - Percentage of Participants With Death [ Time Frame: 12, 24, and 34 months ] [ Designated as safety issue: No ]
    OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.

  • OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months [ Time Frame: 12, 24, and 36 months ] [ Designated as safety issue: No ]
    OS from enrollment was defined as the date of enrollment to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.

  • Percentage of Participants With a Response During the Induction Phase [ Time Frame: Months 1 to 8 ] [ Designated as safety issue: No ]
    Participants without a response assessment (due to any reasons) were considered as non-responders.

  • Percentage of Participants With a Molecular Response in the Induction Phase [ Time Frame: Months 5 and 8 ] [ Designated as safety issue: No ]
    Molecular responders were defined as the proportion of CR/CRu participants with a positive bcl-2/IgH (non-Hodgkin's Lymphoma [NHL] marker) at baseline, whose laboratory values were undetectable after treatment.

  • Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months [ Time Frame: Months 12, 24, and 34 ] [ Designated as safety issue: No ]
    Duration of response (DOR) was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of follicular lymphoma (FL). Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the traditional approach, duration of response was estimated as the proportion of participants alive without progression or relapse of disease with the Kaplan-Meier method.

  • Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months [ Time Frame: Months 12, 24, and 34 ] [ Designated as safety issue: No ]
    DOR was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of FL. Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the competing risk approach, deaths for causes other than FL were considered as competing events. DOR was estimated with the cumulative incidence of progression, relapse, or death as a result of FL.


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   (Adult, Senior)
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, 20133
Milano, Italy, 20162
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, 00144
Roma, Italy, 00161
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

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
Results First Received: September 12, 2014
Last Updated: December 3, 2014
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on September 27, 2016