Status:
COMPLETED
A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy...
Eligibility Criteria
Inclusion
- Histologically confirmed Cluster of Differentiation 20-positive (CD20+) follicular NHL Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma) according to World Health Organization (WHO) classification system
- Participants must have received and must have relapsed or been refractory to, one or more lines of adequate therapy prior to enrollment, including at least one line consisting of immunotherapy and/or chemotherapy and/or radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2
Exclusion
- Transformation to high-grade lymphoma
- Aggressive lymphoma (for example, mantle cell lymphoma \[MCL\])
- Presence or history of central nervous system (CNS) lymphomatous disease
- Other malignancy within 5 years prior to enrollment, except for curatively treated carcinoma in situ of the cervix, squamous cell carcinoma of the skin or basal cell skin cancer, or cervical carcinoma Stage 1B or less, breast cancer in situ or localized prostate cancer Stage T1c if treated with curative intent and relapse- and metastasis-free for at least 2 years prior to enrollment
- Inadequate hematological, hepatic or renal function
- Known human immunodeficiency virus (HIV) infection
- Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B or C)
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
December 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2018
Estimated Enrollment :
692 Patients enrolled
Trial Details
Trial ID
NCT01461928
Start Date
December 20 2011
End Date
June 2 2018
Last Update
August 6 2019
Active Locations (180)
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1
University "Mother Theresa" Hospital Center; Oncology Department
Tirana, Albania, 1000
2
CEMIC Saavedra
Buenos Aires, Argentina, 1431
3
Instituto Damic
Córdoba, Argentina, X5003DCE
4
Hospital Privado de Comunidad; Oncology
Mar del Plata, Argentina, 7600