Clinical trial NCT01144364: A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-06-15
Enrollment: 234
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Disease Progression or Death
timeFrame: 12, 24, and 34 months
measure: PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months
timeFrame: 12, 24, and 34 months
Secondary outcomes:
measure: Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months
timeFrame: 12, 24, and 36 months
measure: Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months
timeFrame: 12, 24, and 36 months
measure: Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months
timeFrame: 12, 24, and 34 months
measure: Overall Survival (OS) From Randomization - Percentage of Participants With Death
timeFrame: 12, 24, and 34 months
measure: OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months
timeFrame: 12, 24, and 36 months
measure: Percentage of Participants With a Response During the Induction Phase
timeFrame: Months 1 to 8
measure: Percentage of Participants With a Molecular Response in the Induction Phase
timeFrame: Months 5 and 8
measure: Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months
timeFrame: Months 12, 24, and 34
measure: 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
timeFrame: Months 12, 24, and 34
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
state: Abruzzo
city: Reggio Calabria
country: Italy
facility: Ospedale Riuniti; Divisione Di Ematologia
state: Calabria
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
state: Campania
city: Napoli
country: Italy
facility: Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia
state: Campania
city: Napoli
country: Italy
facility: Ospedale Cardarelli; Divisione Di Ematologia
state: Campania
city: Nocera Inferiore
country: Italy
facility: Presidio Ospedaliero Umberto I; U.O. Di Medicina Interna Ed Oncoematologia
state: Campania
city: Bologna
country: Italy
facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Ematologia
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Radiologia
state: Emilia-Romagna
city: Piacenza
country: Italy
facility: Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia
state: Emilia-Romagna
city: Udine
country: Italy
facility: Policlinico Universitario; Clinica Oncologia - Padiglione Pennato
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Ospedale S. Eugenio; Divisione Di Ematologia
state: Lazio
city: Roma
country: Italy
facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
state: Lazio
city: Roma
country: Italy
facility: Uni Cattolica; Divisione Di Ematologia
state: Lazio
city: Bergamo
country: Italy
facility: ASST PAPA GIOVANNI XXIII; Ematologia
state: Lombardia
city: Brescia
country: Italy
facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
state: Lombardia
city: Cremona
country: Italy
facility: ASST DI CREMONA; U.O.S. di Ematologia
state: Lombardia
city: Milano
country: Italy
facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
state: Lombardia
city: Milano
country: Italy
facility: Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
state: Lombardia
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
state: Lombardia
city: Monza
country: Italy
facility: ASST DI MONZA; Ematologia
state: Lombardia
city: Ancona
country: Italy
facility: Ospedale Regionale Di Torrette; Clinica Di Ematologia
state: Marche
city: Pesaro
country: Italy
facility: Ospedale Civile; S.C. Ematologia
state: Marche
city: Alessandria
country: Italy
facility: Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
state: Piemonte
city: Biella
country: Italy
facility: Az. Osp. Di Biella; Divisione Di Ematologia
state: Piemonte
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
state: Piemonte
city: Cuneo
country: Italy
facility: Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia
state: Piemonte
city: Orbassano
country: Italy
facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
state: Piemonte
city: Torino
country: Italy
facility: A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
state: Piemonte
city: Torino
country: Italy
facility: A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
state: Piemonte
city: Bari
country: Italy
facility: Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
state: Puglia
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
state: Puglia
city: Cagliari
country: Italy
facility: Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
state: Sardegna
city: Messina
country: Italy
facility: Az. Osp. Papardo; Struttura Complessa Di Ematologia
state: Sicilia
city: Palermo
country: Italy
facility: Ospedale V. Cervello; U.O. Ematologia E Trapianti
state: Sicilia
city: Via S. Sofia 78
country: Italy
facility: Ospedale Ferrarotto; Divisione Di Ematologia
state: Sicilia
city: Firenze
country: Italy
facility: Az. Osp. Di Careggi; Divisione Di Ematologia
state: Toscana
city: Pisa
country: Italy
facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia
state: Toscana
city: Bolzano
country: Italy
facility: Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo
state: Trentino-Alto Adige
city: Perugia
country: Italy
facility: Dept. Medicina Clinica E Sperimentale; Sez. Medicina Interna E Scienze Oncologiche - Pol. Monteluce
state: Umbria
city: Venezia
country: Italy
facility: Ospedale Civile Ss. Giovanni E Paolo; Ematologia
state: Veneto
city: Verona
country: Italy
facility: Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: Ladetto M, Lobetti-Bodoni C, Mantoan B, Ceccarelli M, Boccomini C, Genuardi E, Chiappella A, Baldini L, Rossi G, Pulsoni A, Di Raimondo F, Rigacci L, Pinto A, Galimberti S, Bari A, Rota-Scalabrini D, Ferrari A, Zaja F, Gallamini A, Specchia G, Musto P, Rossi FG, Gamba E, Evangelista A, Vitolo U; Fondazione Italiana Linfomi. Persistence of minimal residual disease in bone marrow predicts outcome in follicular lymphomas treated with a rituximab-intensive program. Blood. 2013 Nov 28;122(23):3759-66. doi: 10.1182/blood-2013-06-507319. Epub 2013 Oct 1.
citation: Vitolo U, Ladetto M, Boccomini C, Baldini L, De Angelis F, Tucci A, Botto B, Chiappella A, Chiarenza A, Pinto A, De Renzo A, Zaja F, Castellino C, Bari A, Alvarez De Celis I, Evangelista A, Parvis G, Gamba E, Lobetti-Bodoni C, Ciccone G, Rossi G. Rituximab maintenance compared with observation after brief first-line R-FND chemoimmunotherapy with rituximab consolidation in patients age older than 60 years with advanced follicular lymphoma: a phase III randomized study by the Fondazione Italiana Linfomi. J Clin Oncol. 2013 Sep 20;31(27):3351-9. doi: 10.1200/JCO.2012.44.8290. Epub 2013 Aug 19.