Features of ongoing phase 3 frontline FL trials
| Name . | Trial . | Enrollment target . | Patients . | Primary end point . | Important secondary end points . |
|---|---|---|---|---|---|
| Limited stage | |||||
| FORTplus (NCT05045664)7 | RT 24 Gy + rituximab vs 4 Gy + obinutuzumab | 100 | Age, ≥18 years Stage IA or IIA, nonbulky (≤7 cm) Exclude extranodal | CRR based on CT scan | Metabolic CRR PFS OS Rate of AEs |
| FIL_GAZEBO (NCT05929222)8 | RT 24 Gy vs 24 Gy + obintuzumab | 190 | Age, ≥18 years Stage IA or IIA, or IE, nonbulky (<7 cm) FLIPI of <2, FLIPI2 of ≤2 | PFS | CRR ORR MRD negativity Rate of AEs |
| Low tumor burden | |||||
| SWOG2308 (NCT06337318)23 | Mosunetuzumab vs rituximab | 600 | Age, ≥18 years Define low tumor burden: not fulfill GELF criteria Participants must either be experiencing distress due to disease or prefer active management rather than watch and wait Allow patients with stage I disease who decline/are not suitable for RT | PFS 3-year PFS | OS ORR Rate of AEs |
| High tumor burden | |||||
| MorningLyte (NCT06284122)31 | Mosunetuzumab-lenalidomide vs CIT (anti-CD20 with CHOP or benda) | 790 | Age, ≥18 years FLIPI 2-5 All Ann Arbor stages Need for treatment as per GELF | PFS | CRR POD24 TTNT OS Rate of AEs QOL outcome |
| EPCORE FL-2 (NCT06191744)34 | Epcoritamab-R2 vs CIT (anti-CD20 with CHOP or benda) vs R2 | 1080 | Age, ≥18 years FLIPI 2-5 Stage II to IV disease Need for treatment as per GELF | CR30 between Epco-R2 vs CIT PFS between Epco-R2 vs CIT | OS PFS-2 MRD negativity rate Outcome between Epco-R2 vs R2 QOL outcome |
| OLYMPIA-1 (NCT06091254)38 | Odronextamab vs CIT (R-CHOP, R-CVP, R-benda) | 478 | Age, ≥18 years Stage II bulky to IV disease Need for treatment as per GELF | CR30 | PFS OS TTNT Rate of AEs QOL outcome |
| OLYMPIA-2 (NCT06097364)39 | Odronextamab-CHOP/CVP vs Odronextamab-CHOP/CVP followed by odronextamab maintenance vs R-CHOP with RM | 733 | Age, ≥18 years Stage II bulky to IV disease Need for treatment as per GELF | CR30 | PFS OS TTNT Rate of AEs QOL outcome |
| SOUNDTRACK-F1 (NCT06549595)40 | AZD0486-rituximab vs CIT (R-CHOP, R-CVP, R-benda) | 1015 | Age, ≥18 years Need for treatment as per GELF | PFS | CRR CR30 OS |
| FIL_FOLL19 (NCT05058404)41 | PET CR and MRD-negative after 4 cycles CIT, complete 2 more cycles CIT vs 2 more cycles anti-CD20 only (omit chemotherapy) All patients receive anti-CD20 maintenance | 602 | Age, ≥18 years Stage II to IV disease Need for treatment as per GELF | PFS | OS ORR CRR MRD negativity Rate of AEs QOL outcome |
| Name . | Trial . | Enrollment target . | Patients . | Primary end point . | Important secondary end points . |
|---|---|---|---|---|---|
| Limited stage | |||||
| FORTplus (NCT05045664)7 | RT 24 Gy + rituximab vs 4 Gy + obinutuzumab | 100 | Age, ≥18 years Stage IA or IIA, nonbulky (≤7 cm) Exclude extranodal | CRR based on CT scan | Metabolic CRR PFS OS Rate of AEs |
| FIL_GAZEBO (NCT05929222)8 | RT 24 Gy vs 24 Gy + obintuzumab | 190 | Age, ≥18 years Stage IA or IIA, or IE, nonbulky (<7 cm) FLIPI of <2, FLIPI2 of ≤2 | PFS | CRR ORR MRD negativity Rate of AEs |
| Low tumor burden | |||||
| SWOG2308 (NCT06337318)23 | Mosunetuzumab vs rituximab | 600 | Age, ≥18 years Define low tumor burden: not fulfill GELF criteria Participants must either be experiencing distress due to disease or prefer active management rather than watch and wait Allow patients with stage I disease who decline/are not suitable for RT | PFS 3-year PFS | OS ORR Rate of AEs |
| High tumor burden | |||||
| MorningLyte (NCT06284122)31 | Mosunetuzumab-lenalidomide vs CIT (anti-CD20 with CHOP or benda) | 790 | Age, ≥18 years FLIPI 2-5 All Ann Arbor stages Need for treatment as per GELF | PFS | CRR POD24 TTNT OS Rate of AEs QOL outcome |
| EPCORE FL-2 (NCT06191744)34 | Epcoritamab-R2 vs CIT (anti-CD20 with CHOP or benda) vs R2 | 1080 | Age, ≥18 years FLIPI 2-5 Stage II to IV disease Need for treatment as per GELF | CR30 between Epco-R2 vs CIT PFS between Epco-R2 vs CIT | OS PFS-2 MRD negativity rate Outcome between Epco-R2 vs R2 QOL outcome |
| OLYMPIA-1 (NCT06091254)38 | Odronextamab vs CIT (R-CHOP, R-CVP, R-benda) | 478 | Age, ≥18 years Stage II bulky to IV disease Need for treatment as per GELF | CR30 | PFS OS TTNT Rate of AEs QOL outcome |
| OLYMPIA-2 (NCT06097364)39 | Odronextamab-CHOP/CVP vs Odronextamab-CHOP/CVP followed by odronextamab maintenance vs R-CHOP with RM | 733 | Age, ≥18 years Stage II bulky to IV disease Need for treatment as per GELF | CR30 | PFS OS TTNT Rate of AEs QOL outcome |
| SOUNDTRACK-F1 (NCT06549595)40 | AZD0486-rituximab vs CIT (R-CHOP, R-CVP, R-benda) | 1015 | Age, ≥18 years Need for treatment as per GELF | PFS | CRR CR30 OS |
| FIL_FOLL19 (NCT05058404)41 | PET CR and MRD-negative after 4 cycles CIT, complete 2 more cycles CIT vs 2 more cycles anti-CD20 only (omit chemotherapy) All patients receive anti-CD20 maintenance | 602 | Age, ≥18 years Stage II to IV disease Need for treatment as per GELF | PFS | OS ORR CRR MRD negativity Rate of AEs QOL outcome |
benda, bendamustine; CT, computed tomography; Epco, epcoritamab; FLIPI, FL International Prognostic Index; GELF, Groupe d'Etude des Lymphomes Folliculaires criteria; IE, stage 1 extranodal; ORR, overall response rate; TTNT, time to next treatment.