A Pharmacokinetic Study Comparing SCT400 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
- Sponsor
- Sinocelltech Ltd.
- Study ID
- NCT02456207
- Phase
- PHASE2
- Status
- Unknown
Conditions
- B-cell Non Hodgkin's Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- SCT400 — DRUG
- Rituximab — DRUG
Study Details
The primary objective of the study is to assess the pharmacokinetic (PK) similarity of SCT400 versus rituximab (MabThera®) in patients with CD20+ B-cell Non-Hodgkin's Lymphoma. The secondary objective of the study is to evaluate the pharmacodynamics (PD) and safety of SCT400 versus rituximab (MabThera®), as well as the presence of human anti-chimeric antibodies (HACA).
Key Dates
- Start date
- May 31, 2015
- Status verified
- May 2014
- Primary completion
- Dec 31, 2015
- Completion
- Dec 31, 2015
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ExperimentalSCT400:375 mg/m2, iv, one infusion
- Active Comparator: Active ComparatorRituximab: 375 mg/m2, iv, one infusion
Primary Outcome Measure
Area under the curve (AUC) for SCT400 and rituximab concentrations [ Time Frame: 85 days ]