Rituximab Plus MG4101 Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)

Phase 2TerminatedNCT03578198

Seoul National University Hospital12 enrolled

Overview

Phase II study of rituximab plus MG4101 in patients with relapsed or refractory indolent CD20-positive non-Hodgkin lymphoma (NHL) Investigator-Initiated Trials

Multi-center trial, Phase II, non-randomized, open-label, single-arm study with combined therapy of rituximab plus MG4101 in patients with indolent CD20-positive NHLs who has relapsed or refractory to prior chemotherapy or chemo-radiotherapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

CD20-positive Non-Hodgkin Lymphoma

Interventions

Rituximab + MG4101DRUG

1. 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)

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histologically confirmed indolent CD20-positive NHLs (iNHLs; follicular lymphoma grade 1-3a, marginal zone B-cell lymphoma, small lymphocytic lymphoma, Waldenstrom macroglobulinemia) 2. CD20-positive iNHL patients who relapsed or progressed 3. ≥ 19 years 4. ECOG PS 0-2 5. At least one bidimensionally measurable disease (or presence of IgM paraproteinemia ≥ 2 x ULN for Waldenstrom macroglobulinemia) 6. Adequate hematologic, renal, and hepatic functions 7. Appropriate methods of contraception during the study 8. Written informed consent Exclusion Criteria: 1. Not all of the above inclusion criteria are met. 2. Prior chemotherapy within 4 weeks or radiotherapy within 6 weeks 3. Corticosteroids \> 10mg/day during last 28 days 4. Evidence of CNS involvement by lymphomas 5. Active HBV/HCV infections, known HIV infection 6. Prior diagnosis of cancers within 5 years 7. Serious concurrent cardiovascular disease 8. Patients who are pregnant or lactating

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Overall response rate

Investigator-assessed, confirmed objective response by revised response criteria

Time frame: Through treatment completion, an average of 25 weeks

Secondary Outcomes

Complete remission rate

Confirmed complete remission by revised response criteria

Time frame: Through treatment completion, an average of 25 weeks

Progression-free survival

PFS as defined by revised response criteria

Time frame: From date of initiation until the date of first documented progression, whichever came first, assessed up to 2 years

Overall survival

OS as defined by revised response criteria

Time frame: Through study completion, an average of 2 years

Data from ClinicalTrials.gov

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