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

October 24, 2022 updated by: Tae Min Kim, Seoul National University Hospital

Phase II Study of Rituximab Plus MG4101 in Patients With Relapsed or Refractory Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Drug: Rituximab + MG4101

  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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: Through treatment completion, an average of 25 weeks
Investigator-assessed, confirmed objective response by revised response criteria
Through treatment completion, an average of 25 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Gyeongsang National University Hospital
Hallym University Medical Center
Kyunghee University Medical Center

Investigators

  • Principal Investigator: Tae Min Kim, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2018

Primary Completion (Actual)

April 7, 2022

Study Completion (Actual)

April 7, 2022

Study Registration Dates

First Submitted

June 25, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Truximab+MG4101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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