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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
234
Intravenous repeating dose
Percentage of Participants With Disease Progression or Death
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.
Time frame: 12, 24, and 34 months
PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 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.
Time frame: 12, 24, and 34 months
Percentage of Participants Estimated to be Free of Progression at 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.
Time frame: 12, 24, and 36 months
Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 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.
Time frame: 12, 24, and 36 months
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Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
Pescara, Abruzzo, Italy
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
Bari, Apulia, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
San Giovanni Rotondo, Apulia, Italy
Ospedale Riuniti; Divisione Di Ematologia
Reggio Calabria, Calabria, Italy
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
Naples, Campania, Italy
Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia
Naples, Campania, Italy
Ospedale Cardarelli; Divisione Di Ematologia
Naples, 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
...and 35 more locations
Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 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.
Time frame: 12, 24, and 34 months
Overall Survival (OS) From Randomization - Percentage of Participants With Death
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.
Time frame: 12, 24, and 34 months
OS From Enrollment - Percentage of Participants Estimated to be Alive at 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.
Time frame: 12, 24, and 36 months
Percentage of Participants With a Response During the Induction Phase
Participants without a response assessment (due to any reasons) were considered as non-responders.
Time frame: Months 1 to 8
Percentage of Participants With a Molecular Response in the Induction Phase
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.
Time frame: Months 5 and 8
Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months
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.
Time frame: Months 12, 24, and 34
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
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.
Time frame: Months 12, 24, and 34