Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Seoul National University Hospital
With
Hallym University Medical Center
Kyunghee University Medical Center
Gyeongsang National University Hospital
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.
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
Clareo Health | Rituximab Plus MG4101 Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)