CD20-positive Non-Hodgkin Lymphoma
Conditions
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.
Interventions
DRUGRituximab + 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)
Sponsors
Hallym University Medical Center
Kyunghee University Medical Center
Gyeongsang National University Hospital
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | Through treatment completion, an average of 25 weeks | Investigator-assessed, confirmed objective response by revised response criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission rate | Through treatment completion, an average of 25 weeks | Confirmed complete remission by revised response criteria |
| 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 |
| Overall survival | Through study completion, an average of 2 years | OS as defined by revised response criteria |
Countries
South Korea
Outcome results
None listed