Clinical trial NCT01153971: A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas
Official title: An Open-label Study of Fludarabine and Cyclophosphamide Plus MabThera Followed by Maintenance With MabThera on Failure-free Survival in Treatment-naïve Patients With Advanced Indolent B-cell Nonfollicular Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients 18-65 years of age;
* previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
* active disease;
* \>=3 involved sites.

Exclusion Criteria:

* typical chronic lymphocytic leukemia;
* other malignancies within 3 years before study, except basal or squamous cell skin cancer or cancer in situ of the cervix;
* systemic corticosteroid use for \>1 month;
* significant cardiovascular disease;
* central nervous system involvement;
* hepatitis B or C virus infection, or HIV infection.

Primary outcomes:
measure: Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date
timeFrame: Month 28
Secondary outcomes:
measure: Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase
timeFrame: Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase)
measure: Percentage of Participants Achieving a Response by Response Type and Study Phase
timeFrame: Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40
measure: Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
measure: FFS - Percentage of Participants With an Event
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
measure: FFS - Time to Event
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
measure: Overall Survival (OS) - Percentage of Participants Estimated to be Alive
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
measure: OS - Percentage of Participants With an Event
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
measure: OS - Time to Event
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
measure: Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
measure: DFS - Percentage of Participants With an Event
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
measure: DFS - Time to Event
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
measure: Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
measure: PFS - Percentage of Participants With an Event
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
measure: PFS - Time to Event
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
measure: Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
measure: DR - Percentage of Participants With an Event
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
measure: DR - Time to Event
timeFrame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
state: Abruzzo
city: Pescara
country: Italy
facility: Ospedale Civile; Divisione Di Oncologia
state: Abruzzo
city: Rionero in Vulture
country: Italy
facility: Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia
state: Basilicata
city: Reggio Calabria
country: Italy
facility: Ospedale Riuniti; Divisione Di Ematologia
state: Calabria
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia
state: Emilia-Romagna
city: Roma
country: Italy
facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
state: Lazio
city: Brescia
country: Italy
facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. 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: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
state: Lombardia
city: Alessandria
country: Italy
facility: Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
state: Piemonte
city: Cuneo
country: Italy
facility: Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia
state: Piemonte
city: Torino
country: Italy
facility: A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
state: Piemonte
city: Messina
country: Italy
facility: Az. Osp. Papardo; Struttura Complessa Di Ematologia
state: Sicilia
city: Firenze
country: Italy
facility: Az. Osp. Di Careggi; Divisione Di Ematologia
state: Toscana
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: