A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.
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
2 other identifiers
interventional
97
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2008
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2008
CompletedFirst Posted
Study publicly available on registry
August 20, 2008
CompletedStudy Start
First participant enrolled
November 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2013
CompletedResults Posted
Study results publicly available
February 16, 2015
CompletedAugust 15, 2017
June 1, 2017
4.2 years
August 18, 2008
December 19, 2014
July 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Documented CR, CRi, or PR at the End of Induction Treatment
CR defined as: 1) laboratory CR: peripheral blood lymphocytes (PBL) less than (\<) 4000/microliter (μL), neutrophils (PMN) greater than (\>) 1500/μL, platelets \>100,000/μL, and hemoglobin (Hb) \>11 grams per deciliter (g/dL); 2) clinical CR: lymph nodes (LN) \<1.5 centimeter (cm), and no constitutional symptoms, hepatomegaly (HM) or splenomegaly (SM); 3) instrumental CR: LN \<1.5 cm and no HM/SM, and 4) bone marrow (BM) CR: normocellular aspirate/biopsy for participant age \<30 percent (%) lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to chronic lymphocytic leukemia (CLL), with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from baseline (BL) in the HM/SM, and 1 of the following: PMN \>1500/μL, platelets \>100,000/μL or \>50% improvement from BL, and Hb \>11.0 g/dL or \>50% improvement from BL.
Month 10
Secondary Outcomes (19)
Percentage of Participants With Documented CR, CRi, or PR at the End of Study
Month 35
Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment
Month 10
Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study
Month 35
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
Month 10
Percentage of Participants With CR, CRi, PR, SD, PD, or Relapse at the End of Study
Month 35
- +14 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
375mg/m2 iv on day 1 of course 3; 500mg/m2 iv on day 1 of courses 4-8 (induction phase); 375mg/m2 iv every 8 weeks (maintenance phase).
Eligibility Criteria
You may qualify if:
- adult patients, \>=60 years of age;
- CD20+ chronic lymphocytic leukemia (CLL);
- no previous treatment for CLL;
- ECOG performance status 0-1.
You may not qualify if:
- co-morbid conditions requiring long term use of systemic corticosteroids during study treatment;
- history of severe cardiac disease;
- transformation to aggressive B-cell malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
Bari, Apulia, 70124, Italy
Az. Osp. Pugliese; Dh Oncologico
Catanzaro, Calabria, 88100, Italy
P.O. Annunziata; U.O. Ematologia
Cosenza, Calabria, 87100, Italy
Ospedale Riuniti; Divisione Di Ematologia
Reggio Calabria, Calabria, 89100, Italy
Ospedale Cardarelli; Divisione Di Ematologia
Napoli, Campania, 80131, Italy
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, 40138, Italy
Arcispedale S. Anna; Sezione Di Ematologia
Ferrara, Emilia-Romagna, 44100, Italy
Ospedale S. Eugenio; Divisione Di Ematologia
Rome, Lazio, 00144, Italy
Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
Rome, Lazio, 00161, Italy
Uni Degli Studi Di Genova; 1A Divisione Di Ematologia
Genoa, Liguria, 16132, Italy
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
Milan, Lombardy, 20122, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, 20162, Italy
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
Turin, Piedmont, 10126, Italy
Ospedale Molinette - Universita' Di Torino; Cliniche Universitarie Ematologia I
Turin, Piedmont, 10126, Italy
Az. Osp. Papardo; Struttura Complessa Di Ematologia
Messina, Sicily, 98165, Italy
Ospedale Ferrarotto; Divisione Di Ematologia
Via S. Sofia 78, Sicily, 95123, Italy
Az. Osp. Di Careggi; Divisione Di Ematologia
Florence, Tuscany, 50135, Italy
A.O. Universitaria Senese; Ematologia
Siena, Tuscany, 53100, Italy
Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
Padua, Veneto, 35128, Italy
Policlinico G. B. Rossi; Divisione Di Ematologia
Verona, Veneto, 37134, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2008
First Posted
August 20, 2008
Study Start
November 3, 2008
Primary Completion
January 14, 2013
Study Completion
January 14, 2013
Last Updated
August 15, 2017
Results First Posted
February 16, 2015
Record last verified: 2017-06