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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03578198
Collaborator
Hallym University Medical Center (Other), Kyunghee University Medical Center (Other), Gyeongsang National University Hospital (Other)
12
Enrollment
1
Location
1
Arm
49.7
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Rituximab + MG4101
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Rituximab Plus MG4101 in Patients With Relapsed or Refractory Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
Actual Study Start Date :
Nov 8, 2018
Anticipated Primary Completion Date :
Apr 4, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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
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)

Outcome Measures

Primary Outcome Measures

  1. Overall response rate [Through treatment completion, an average of 25 weeks]

    Investigator-assessed, confirmed objective response by revised response criteria

Secondary Outcome Measures

  1. Complete remission rate [Through treatment completion, an average of 25 weeks]

    Confirmed complete remission by revised response criteria

  2. 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

  3. Overall survival [Through study completion, an average of 2 years]

    OS as defined by revised response criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tae Min Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT03578198
Other Study ID Numbers:
  • Truximab+MG4101
First Posted:
Jul 6, 2018
Last Update Posted:
Feb 7, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Rituximab

Study Results

No Results Posted as of Feb 7, 2022