Description:
Phase II study of rituximab plus MG4101 in patients with relapsed or refractory indolent
CD20-positive non-Hodgkin lymphoma (NHL) Investigator-Initiated Trials
Title
- Brief Title: Rituximab Plus MG4101 Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
- Official Title: Phase II Study of Rituximab Plus MG4101 in Patients With Relapsed or Refractory Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
Clinical Trial IDs
- ORG STUDY ID:
Truximab+MG4101
- NCT ID:
NCT03578198
Conditions
- CD20-positive Non-Hodgkin Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Rituximab + MG4101 | | Rituximab + MG4101 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Rituximab + MG4101 | Experimental | 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) | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 19 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall response rate |
Time Frame: | Through treatment completion, an average of 25 weeks |
Safety Issue: | |
Description: | Investigator-assessed, confirmed objective response by revised response criteria |
Secondary Outcome Measures
Measure: | Complete remission rate |
Time Frame: | Through treatment completion, an average of 25 weeks |
Safety Issue: | |
Description: | Confirmed complete remission by revised response criteria |
Measure: | Progression-free survival |
Time Frame: | From date of initiation until the date of first documented progression, whichever came first, assessed up to 2 years |
Safety Issue: | |
Description: | PFS as defined by revised response criteria |
Measure: | Overall survival |
Time Frame: | Through study completion, an average of 2 years |
Safety Issue: | |
Description: | OS as defined by revised response criteria |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Seoul National University Hospital |
Last Updated
March 17, 2021