Clinical trial NCT00738374: A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.
Official title: A Study of Chlorambucil Plus MabThera as Induction Therapy Followed in Responders by Maintenance Therapy Versus Observation on Response Rate in Patients >=60 Years With Previously Untreated Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphocytic Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-08-20
Enrollment: 97
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the efficacy and safety of MabThera + chlorambucil as induction therapy, followed in responders by maintenance therapy or observation in elderly patients with previously untreated chronic lymphocytic leukemia. During the induction phase patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses of MabThera given every 8 weeks, or no further treatment. The anticipated time on study treatment is 2+ years, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=60 years of age;
* CD20+ chronic lymphocytic leukemia (CLL);
* no previous treatment for CLL;
* ECOG performance status 0-1.

Exclusion Criteria:

* co-morbid conditions requiring long term use of systemic corticosteroids during study treatment;
* history of severe cardiac disease;
* transformation to aggressive B-cell malignancy.

Primary outcomes:
measure: Percentage of Participants With Documented CR, CRi, or PR at the End of Induction Treatment
timeFrame: Month 10
Secondary outcomes:
measure: Percentage of Participants With Documented CR, CRi, or PR at the End of Study
timeFrame: Month 35
measure: Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment
timeFrame: Month 10
measure: Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study
timeFrame: Month 35
measure: Number of Participants With Immunophenotypic CR - BM, Immunophenotypic CR - Peripheral Blood (PB), Molecular CR - BM, or Molecular CR - PB at the End of Induction Treatment
timeFrame: Month 10
measure: Percentage of Participants With CR, CRi, PR, SD, PD, or Relapse at the End of Study
timeFrame: Month 35
measure: Percentage of Participants With Immunophenotypic CR - BM or Immunophenotypic CR - PB at the End of Study
timeFrame: Month 35
measure: Percentage of Participants With Molecular CR - BM or Molecular CR - PB at the End of Study
timeFrame: Month 35
measure: Number of Participants With Disease Progression, Relapse, Death, Withdrawal Because of an Adverse Event (AE), or New CLL Treatment
timeFrame: Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
measure: EFS
timeFrame: Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
measure: Number of Participants With Disease Progression or Death
timeFrame: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
measure: PFS
timeFrame: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
measure: Number of Participants With New CLL Treatment or Death
timeFrame: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
measure: Time to Next Treatment (TTNT)
timeFrame: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
measure: Number of Participants Who Died
timeFrame: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
measure: OS
timeFrame: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
measure: Number of Participants With PD or Death After a Confirmed CR, CRi, or PR
timeFrame: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
measure: Duration of Response
timeFrame: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
measure: Number of Participants With PD or Death After a Confirmed CR/CRi
timeFrame: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
measure: Disease-Free Survival
timeFrame: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Az. Osp. Pugliese; Dh Oncologico
state: Calabria
city: Cosenza
country: Italy
facility: P.O. Annunziata; U.O. Ematologia
state: Calabria
city: Reggio Calabria
country: Italy
facility: Ospedale Riuniti; Divisione Di Ematologia
state: Calabria
city: Napoli
country: Italy
facility: Ospedale Cardarelli; Divisione Di Ematologia
state: Campania
city: Bologna
country: Italy
facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
state: Emilia-Romagna
city: Ferrara
country: Italy
facility: Arcispedale S. Anna; Sezione Di Ematologia
state: Emilia-Romagna
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: Genova
country: Italy
facility: Uni Degli Studi Di Genova; 1A Divisione Di Ematologia
state: Liguria
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: Torino
country: Italy
facility: A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
state: Piemonte
city: Torino
country: Italy
facility: Ospedale Molinette - Universita' Di Torino; Cliniche Universitarie Ematologia I
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: Messina
country: Italy
facility: Az. Osp. Papardo; Struttura Complessa Di Ematologia
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: Siena
country: Italy
facility: A.O. Universitaria Senese; Ematologia
state: Toscana
city: Padova
country: Italy
facility: Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
state: Veneto
city: Verona
country: Italy
facility: Policlinico G. B. Rossi; Divisione Di Ematologia
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: