Rituximab Plus MG4101 Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
NCT ID: NCT03578198
Last Updated: 2022-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2018-11-08
2022-04-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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)
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Hallym University Medical Center
OTHER
Kyunghee University Medical Center
OTHER
Gyeongsang National University Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Tae Min Kim
Professor
Principal Investigators
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Tae Min Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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Truximab+MG4101
Identifier Type: -
Identifier Source: org_study_id
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