A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas
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
1 other identifier
interventional
47
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2005
Longer than P75 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2005
CompletedFirst Submitted
Initial submission to the registry
June 14, 2010
CompletedFirst Posted
Study publicly available on registry
June 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2010
CompletedResults Posted
Study results publicly available
August 21, 2014
CompletedAugust 1, 2017
June 1, 2017
5.2 years
June 14, 2010
August 4, 2014
June 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date
Percentage of participants who at 2 years from the start of treatment remained free from documented disease progression, relapse, or death. Failure status was based on tumor evaluation performed on Month 28. Participants who did not have a tumor evaluation at Month 28 were counted as failures.
Month 28
Secondary Outcomes (17)
Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase
Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase)
Percentage of Participants Achieving a Response by Response Type and Study Phase
Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40
Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
FFS - Percentage of Participants With an Event
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
FFS - Time to Event
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
- +12 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients 18-65 years of age;
- previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
- active disease;
- \>=3 involved sites.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
Pescara, Abruzzo, 65100, Italy
Ospedale Civile; Divisione Di Oncologia
Pescara, Abruzzo, 65124, Italy
Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia
Rionero in Vulture, Basilicate, 85028, Italy
Ospedale Riuniti; Divisione Di Ematologia
Reggio Calabria, Calabria, 89100, Italy
A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
Modena, Emilia-Romagna, 41100, Italy
Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia
Reggio Emilia, Emilia-Romagna, 42100, Italy
Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
Rome, Lazio, 00161, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
Brescia, Lombardy, 25123, 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
Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
Alessandria, Piedmont, 15121, Italy
Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia
Cuneo, Piedmont, 12100, Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
Turin, Piedmont, 10126, Italy
Az. Osp. Papardo; Struttura Complessa Di Ematologia
Messina, Sicily, 98165, Italy
Az. Osp. Di Careggi; Divisione Di Ematologia
Florence, Tuscany, 50135, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY CHAIR
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
June 14, 2010
First Posted
June 30, 2010
Study Start
July 20, 2005
Primary Completion
September 24, 2010
Study Completion
September 24, 2010
Last Updated
August 1, 2017
Results First Posted
August 21, 2014
Record last verified: 2017-06