Status:
COMPLETED
A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Lymphoma, Follicular
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and intravenous rituximab in participants with follicular lymphoma. In the first stage, participants who have ac...
Eligibility Criteria
Inclusion
- CD20-positive follicular non-Hodgkin's lymphoma (NHL)
- Documented partial or complete response a the end of induction treatment with rituximab
- Must have completed induction treatment, and received at least 1 dose of intravenous rituximab maintenance treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of less than and equal to (\<=) 2
- Life expectancy of greater than and equal to (\>=) 6 months
Exclusion
- Histological evidence of transformation of NHL, or types of NHL other than follicular lymphoma
- Presence or history of central nervous system disease
- History of malignancy other than follicular NHL
- Recent major surgery (within 4 weeks prior to screening), excluding lymph node biopsy
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT00930514
Start Date
September 1 2009
End Date
July 1 2013
Last Update
November 2 2016
Active Locations (62)
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1
Buenos Aires, Argentina, 1425
2
Buenos Aires, Argentina, C1114AAN
3
Buenos Aires, Argentina, C1221ADC
4
Córdoba, Argentina, 5000