A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
- Registration Number
- NCT01144364
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
- adult patients 60-75 years of age;
- B-cell follicular NHL;
- no previous treatment;
- active disease, with rapid progression.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 rituximab [Mabthera/Rituxan] -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Disease Progression or Death 12, 24, and 34 months 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 12, 24, and 34 months 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
Name Time Method Percentage of Participants With a Molecular Response in the Induction Phase Months 5 and 8 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.
Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months 12, 24, and 36 months 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 12, 24, and 36 months 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 12, 24, and 34 months 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 12, 24, and 34 months 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.
Percentage of Participants With a Response During the Induction Phase Months 1 to 8 Participants without a response assessment (due to any reasons) were considered as non-responders.
OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months 12, 24, and 36 months 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.
Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months Months 12, 24, and 34 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 Months 12, 24, and 34 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.
Trial Locations
- Locations (45)
Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
🇮🇹Pescara, Abruzzo, Italy
Ospedale Riuniti; Divisione Di Ematologia
🇮🇹Reggio Calabria, Calabria, Italy
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
🇮🇹Napoli, Campania, Italy
Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia
🇮🇹Napoli, Campania, Italy
Ospedale Cardarelli; Divisione Di Ematologia
🇮🇹Napoli, Campania, Italy
Presidio Ospedaliero Umberto I; U.O. Di Medicina Interna Ed Oncoematologia
🇮🇹Nocera Inferiore, Campania, Italy
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
🇮🇹Bologna, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena; Ematologia
🇮🇹Modena, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena; Radiologia
🇮🇹Modena, Emilia-Romagna, Italy
Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia
🇮🇹Piacenza, Emilia-Romagna, Italy
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