Features of ongoing phase 3 R/R FL trials
| Name . | Trial . | Enrollment target . | Patients . | Primary end point . | Important secondary end points . |
|---|---|---|---|---|---|
| ZUMA-22 (NCT05371093)42 | Axi-cel vs SOC (R2, R-CHOP, R-benda) | 230 | Age, ≥18 years R/R after first-line CIT with POD24 After ≥2 previous lines systemic therapy | PFS | OS CRR ORR TTNT Rate of AEs QOL outcome |
| LEDA (NCT05888493)43 | Tisa-cel vs SOC (R2, R-CHOP) | 108 | Age, ≥18 years R/R after ≥2 previous lines systemic therapy | PFS | OS CRR ORR TTNT Rate of AEs |
| TRANSFORM FL (NCT06313996)44 | Liso-cel vs SOC (R2, R-CHOP, R-benda) | 300 | Age, ≥18 years R/R after 2-3 previous lines including anti-CD20 and alkylator R/R after 1 previous line including anti-CD20 and alkylator with high-risk features | PFS | OS CRR ORR TTNT PFS-2 Rate of AEs QOL outcome |
| CELESTIMO (NCT04712097)45 | Mosunetuzumab-lenalidomide vs R2 | 474 | Age, ≥18 years R/R after ≥1 previous lines systemic therapy including immunotherapy or CIT | PFS | OS CRR ORR TTNT Rate of AEs QOL outcome |
| EPCORE FL-1 (NCT05409066)46 | Epcoritamab-R2 vs R2 | 500 | Age, ≥18 years R/R after ≥1 previous lines of CIT (exclude anti-CD20 monotherapy) | PFS | OS CRR MRD negativity |
| OLYMPIA-5 (NCT06149286)47 | Odronextamab-lenalidomide vs R2 | 470 (FL and MZL) | Age, ≥18 years R/R after ≥1 previous lines systemic therapy including immunotherapy or CIT | PFS | OS CRR TTNT Rate of AEs QOL outcome |
| SYMPHONY-1 (NCT04224493)48 | R2-tazemetostat vs R2-placebo | 612 | Age, ≥18 years R/R after ≥1 previous lines systemic therapy including immunotherapy or CIT or chemotherapy No restriction on EZH2 mutation status | PFS | OS CRR ORR TTNT Rate of AEs QOL outcome |
| MAHOGANY (NCT05100862)49 | ZO vs R2 | 750 (FL and MZL) | Age, ≥18 years R/R after ≥1 previous lines systemic therapy including anti-CD20 | PFS | OS CRR ORR TTNT Rate of AEs QOL outcome |
| GOLSEEK-4 (NCT06911502)50 | Golcadomide-rituximab vs investigator’s choice (R2/CIT) | 400 | Age, ≥18 years R/R after ≥1 previous lines systemic therapy including anti-CD20 and an alkylating agent | PFS | OS ORR TTNT PFS-2 QOL outcome MRD negativity |
| Name . | Trial . | Enrollment target . | Patients . | Primary end point . | Important secondary end points . |
|---|---|---|---|---|---|
| ZUMA-22 (NCT05371093)42 | Axi-cel vs SOC (R2, R-CHOP, R-benda) | 230 | Age, ≥18 years R/R after first-line CIT with POD24 After ≥2 previous lines systemic therapy | PFS | OS CRR ORR TTNT Rate of AEs QOL outcome |
| LEDA (NCT05888493)43 | Tisa-cel vs SOC (R2, R-CHOP) | 108 | Age, ≥18 years R/R after ≥2 previous lines systemic therapy | PFS | OS CRR ORR TTNT Rate of AEs |
| TRANSFORM FL (NCT06313996)44 | Liso-cel vs SOC (R2, R-CHOP, R-benda) | 300 | Age, ≥18 years R/R after 2-3 previous lines including anti-CD20 and alkylator R/R after 1 previous line including anti-CD20 and alkylator with high-risk features | PFS | OS CRR ORR TTNT PFS-2 Rate of AEs QOL outcome |
| CELESTIMO (NCT04712097)45 | Mosunetuzumab-lenalidomide vs R2 | 474 | Age, ≥18 years R/R after ≥1 previous lines systemic therapy including immunotherapy or CIT | PFS | OS CRR ORR TTNT Rate of AEs QOL outcome |
| EPCORE FL-1 (NCT05409066)46 | Epcoritamab-R2 vs R2 | 500 | Age, ≥18 years R/R after ≥1 previous lines of CIT (exclude anti-CD20 monotherapy) | PFS | OS CRR MRD negativity |
| OLYMPIA-5 (NCT06149286)47 | Odronextamab-lenalidomide vs R2 | 470 (FL and MZL) | Age, ≥18 years R/R after ≥1 previous lines systemic therapy including immunotherapy or CIT | PFS | OS CRR TTNT Rate of AEs QOL outcome |
| SYMPHONY-1 (NCT04224493)48 | R2-tazemetostat vs R2-placebo | 612 | Age, ≥18 years R/R after ≥1 previous lines systemic therapy including immunotherapy or CIT or chemotherapy No restriction on EZH2 mutation status | PFS | OS CRR ORR TTNT Rate of AEs QOL outcome |
| MAHOGANY (NCT05100862)49 | ZO vs R2 | 750 (FL and MZL) | Age, ≥18 years R/R after ≥1 previous lines systemic therapy including anti-CD20 | PFS | OS CRR ORR TTNT Rate of AEs QOL outcome |
| GOLSEEK-4 (NCT06911502)50 | Golcadomide-rituximab vs investigator’s choice (R2/CIT) | 400 | Age, ≥18 years R/R after ≥1 previous lines systemic therapy including anti-CD20 and an alkylating agent | PFS | OS ORR TTNT PFS-2 QOL outcome MRD negativity |
MZL, marginal zone lymphoma.