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

Phase 2

Terminated

• Conditions: CD20-positive Non-Hodgkin Lymphoma
• Interventions: Drug: Rituximab + MG4101

• Registration Number: NCT03578198
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2018-06-25
• Study First Submitted QC: 2018-06-25
• Study First Posted: 2018-07-06
• Study Start: 2018-11-08
• Primary Completion: 2022-04-07
• Study Completion: 2022-04-07
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab + MG4101	Rituximab + MG4101	Drug: 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 Measures

Name	Time	Method
Overall response rate	Through treatment completion, an average of 25 weeks	Investigator-assessed, confirmed objective response by revised response criteria

Secondary Outcome Measures

Name	Time	Method
Complete remission rate	Through treatment completion, an average of 25 weeks	Confirmed complete remission by revised response criteria
Progression-free survival	From date of initiation until the date of first documented progression, whichever came first, assessed up to 2 years	PFS as defined by revised response criteria
Overall survival	Through study completion, an average of 2 years	OS as defined by revised response criteria

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of