Clinical trial · Interventional
Rituximab Plus MG4101 Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
Phase II Study of Rituximab Plus MG4101 in Patients With Relapsed or Refractory Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
NCT03578198CI-TRIAL-00061775MG4101terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Issues in supply of IP
Summary
Brief summary (as posted)
Phase II study of rituximab plus MG4101 in patients with relapsed or refractory indolent CD20-positive non-Hodgkin lymphoma (NHL) Investigator-Initiated Trials
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CD20-positive Non-Hodgkin Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab + MG4101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab + MG4101
- description
- 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)
- interventionNames
- Drug: Rituximab + MG4101
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- Through treatment completion, an average of 25 weeks
- description
- Investigator-assessed, confirmed objective response by revised response criteria
Secondary outcomes (3)
- measure
- Complete remission rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.