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
Phase 3
60 Years
75 Years
60 Years
75 Years
Not Enrolling
Both
Non-Hodgkin's Lymphoma
Both
Non-Hodgkin's Lymphoma
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Failure-free survival\n
Outcome Time Frame:
From first patient enrolled to approximately 42 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Chair
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy: Ministry of Health
Study ID:
ML17638
NCT ID:
NCT01144364
Start Date:
January 2004
Completion Date:
July 2011
Related Keywords:
- Non-Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
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