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

Primary Purpose

CD20-positive Non-Hodgkin Lymphoma

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rituximab + MG4101
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CD20-positive Non-Hodgkin Lymphoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab + MG4101

Arm Description

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)

Outcomes

Primary Outcome Measures

Overall response rate
Investigator-assessed, confirmed objective response by revised response criteria

Secondary Outcome Measures

Complete remission rate
Confirmed complete remission by revised response criteria
Progression-free survival
PFS as defined by revised response criteria
Overall survival
OS as defined by revised response criteria

Full Information

First Posted
June 25, 2018
Last Updated
October 24, 2022
Sponsor
Seoul National University Hospital
Collaborators
Hallym University Medical Center, Kyunghee University Medical Center, Gyeongsang National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03578198
Brief Title
Rituximab Plus MG4101 Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
Acronym
MG4101
Official Title
Phase II Study of Rituximab Plus MG4101 in Patients With Relapsed or Refractory Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Issues in supply of IP
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
April 7, 2022 (Actual)
Study Completion Date
April 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Hallym University Medical Center, Kyunghee University Medical Center, Gyeongsang National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CD20-positive Non-Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab + MG4101
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Rituximab + MG4101
Intervention Description
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 Information:
Title
Overall response rate
Description
Investigator-assessed, confirmed objective response by revised response criteria
Time Frame
Through treatment completion, an average of 25 weeks
Secondary Outcome Measure Information:
Title
Complete remission rate
Description
Confirmed complete remission by revised response criteria
Time Frame
Through treatment completion, an average of 25 weeks
Title
Progression-free survival
Description
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
Title
Overall survival
Description
OS as defined by revised response criteria
Time Frame
Through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Not all of the above inclusion criteria are met. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae Min Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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