A Study Comparing the Efficiency and Safety of S-CHOP(Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone) Versus R-CHOP in Untreated CD20(Cluster of Differentiation Antigen 20)-Positive DLBCL Patients
NCT02772822 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330
Last updated 2016-05-16
Summary
The primary objective of the study is to assess the efficiency of SCT400 plus CHOP versus Rituximab plus CHOP in untreated CD20-positive DLBCL Patients.
The secondary objective of the study is to evaluate the safety of SCT400 plus CHOP, as well as the presence of human anti-chimeric antibodies (HACA).
Conditions
Interventions
- DRUG
-
SCT400 plus CHOP
- DRUG
-
Rituximab plus CHOP
Sponsors & Collaborators
-
Sinocelltech Ltd.
lead INDUSTRY
Principal Investigators
-
Yuan kai Shi, PhD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing, China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-06-30
- Primary Completion
- 2019-06-30
- Completion
- 2019-12-31
Countries
- China
Study Locations
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