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

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase II study of rituximab plus MG4101 in patients with relapsed or refractory indolent CD20-positive non-Hodgkin lymphoma (NHL) Investigator-Initiated Trials

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Gyeongsang National University Hospital; Hallym University Medical Center; Kyunghee University Medical Center; Seoul National University Bundang Hospital
• Treatments: Rituximab

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