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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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CD20-positive Non-Hodgkin Lymphoma

Intervention / Treatment
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* Drug: Rituximab + MG4101


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab + MG4101<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | 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 | Confirmed complete remission by revised response criteria | Through treatment completion, an average of 25 weeks | 
| Progression-free survival | 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 | OS as defined by revised response criteria | Through study completion, an average of 2 years |