Rituximab Plus MG4101 Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
- Sponsor
- Seoul National University Hospital
- Study ID
- NCT03578198
- Phase
- PHASE2
- Status
- Terminated
Conditions
- CD20-positive Non-Hodgkin Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab + MG4101 — DRUG1. Induction phase: * Rituximab (Truxima) 375mg/m2 IV Weekly (X4) * MG4101 3x107 cells/kg IV Weekly (X4) 2. Maintenance phase * Rituximab (Truxima) 375mg/m2 IV q 4 weeks (X4) * MG4101 3x107 cells/kg IV q 4 weeks (X4)
Study Details
Phase II study of rituximab plus MG4101 in patients with relapsed or refractory indolent CD20-positive non-Hodgkin lymphoma (NHL) Investigator-Initiated Trials
Key Dates
- Start date
- Nov 8, 2018
- Status verified
- Oct 2022
- Primary completion
- Apr 7, 2022
- Completion
- Apr 7, 2022
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Rituximab + MG4101Drug: Rituximab + MG4101 Induction phase: Rituximab (Truxima) 375mg/m2 IV Weekly (X4) MG4101 3x107 cells/kg IV Weekly (X4) Maintenance phase Rituximab (Truxima) 375mg/m2 IV q 4 weeks (X4) MG4101 3x107 cells/kg IV q 4 weeks (X4)
Primary Outcome Measure
Overall response rate [ Time Frame: Through treatment completion, an average of 25 weeks ]