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

NCT03578198 | Terminated Phase 2

• 1 other identifier: Truximab+MG4101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

CD20-positive Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Investigator-assessed, confirmed objective response by revised response criteria

  Through treatment completion, an average of 25 weeks

Secondary Outcomes (3)

• Complete remission rate

  Through treatment completion, an average of 25 weeks

• Progression-free survival

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

• Overall survival

  Through study completion, an average of 2 years

Study Arms (1)

Rituximab + MG4101

EXPERIMENTAL

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)

Drug: Rituximab + MG4101

Interventions

Rituximab + MG4101 DRUG

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)

Rituximab + MG4101

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed indolent CD20-positive NHLs (iNHLs; follicular lymphoma grade 1-3a, marginal zone B-cell lymphoma, small lymphocytic lymphoma, Waldenstrom macroglobulinemia)
• CD20-positive iNHL patients who relapsed or progressed
• ≥ 19 years
• ECOG PS 0-2
• At least one bidimensionally measurable disease (or presence of IgM paraproteinemia ≥ 2 x ULN for Waldenstrom macroglobulinemia)
• Adequate hematologic, renal, and hepatic functions
• Appropriate methods of contraception during the study
• Written informed consent

You may not qualify if:

• Prior chemotherapy within 4 weeks or radiotherapy within 6 weeks
• Corticosteroids \> 10mg/day during last 28 days
• Evidence of CNS involvement by lymphomas
• Active HBV/HCV infections, known HIV infection
• Prior diagnosis of cancers within 5 years
• Serious concurrent cardiovascular disease
• Patients who are pregnant or lactating

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Hallym University Medical Center: collaborator
• Kyunghee University Medical Center: collaborator
• Gyeongsang National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tae Min Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: November 8, 2018
• Primary Completion: April 7, 2022
• Study Completion: April 7, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)