Selected clinical trials in early-stage Hodgkin lymphoma using novel agents
| Trial . | N . | Clinical disease features . | Median age, y . | Therapy received/arms of treatment . | Median follow-up, y . | Response . | PFS . | OS . |
|---|---|---|---|---|---|---|---|---|
| BV - AVD18 | 34 | Stage I/II, favorable and unfavorable, nonbulky only | 36 | BV - AVD × 2 → PET 1. If PET–, then BV - AVD × 2 (total 4) 2. If PET+, then BV - AVD × 4 (total 6) | 3.2 | ORR and CR at EOT 91.2% | 3-year PFS 94% | 3-year OS 97% |
| ABVD followed by BV consolidation20 | 41 | Stage I/II, favorable and unfavorable non-bulky only | 29 | ABVD × 2 → PET 3. If favorable and PET–, then BV consolidation 4. If favorable and PET+ or unfavorable and PET–, then ABVD × 2 + BV consolidation 5. If unfavorable and PET+, then ABVD × 4 + BV consolidation | 3.9 | CR rate 95% | 3-year PFS 92% | 3-year OS 97% |
| BV - AVD19 | 117 | Stage I/II, unfavorable only | 32 | BV-AVD × 4 → PET If PET–, then 1. 30 Gy ISRT 2. 20 Gy ISRT 3. 30 consolidation volume radiotherapy 4. No radiotherapy | 3.8 | EOT CR rates for 4 cohorts 1. 93% 2. 100% 3. 93% 4. 97% | Overall 2-year PFS 94% 2-year PFS for 4 cohorts 1. 93.1% 2. 97% 3. 90% 4. 97% | Overall 2-year OS 99.1% |
| NIVAHL21 | 109 | Stage I/II, unfavorable only | 27 | 1. Nivo-AVD × 4 + 30 Gy ISRT 2. Sequential therapy: nivo × 4 doses → nivo-AVD × 2 → AVD × 2 + 30 Gy ISRT | 1.2 in group 1 and 1.1 group 2 | Group 1: ORR 100%, CR 83% Group 2: ORR 98%, CR 84% | 12-month PFS: Group 1: 100% Group 2: 98% | 12-month OS 100% in both groups |
| Sequential pembrolizumab and AVD22 | 30 | Stage I/II unfavorable only, stage III/IV | 29 | Pembro × 3 → AVD × 4-6 (4 cycles for early stage, 6 cycles for advanced stage or early-stage bulky) | 1.9 | CMR after pembro 37%, CMR after AVD 100%, EOT CMR 100% | Median PFS not reached, 2-year PFS 100% | Median OS not reached, 2-year OS 100% |
| Pembrolizumab and AVD23 | 30 | Stages I, II, III, IV | 32 | Pembro + AVD (2-6 cycles) | 0.86 | 68% PET2–, 78% EOT PET– | 1-year PFS 96% | 1-year OS 100% |
| Trial . | N . | Clinical disease features . | Median age, y . | Therapy received/arms of treatment . | Median follow-up, y . | Response . | PFS . | OS . |
|---|---|---|---|---|---|---|---|---|
| BV - AVD18 | 34 | Stage I/II, favorable and unfavorable, nonbulky only | 36 | BV - AVD × 2 → PET 1. If PET–, then BV - AVD × 2 (total 4) 2. If PET+, then BV - AVD × 4 (total 6) | 3.2 | ORR and CR at EOT 91.2% | 3-year PFS 94% | 3-year OS 97% |
| ABVD followed by BV consolidation20 | 41 | Stage I/II, favorable and unfavorable non-bulky only | 29 | ABVD × 2 → PET 3. If favorable and PET–, then BV consolidation 4. If favorable and PET+ or unfavorable and PET–, then ABVD × 2 + BV consolidation 5. If unfavorable and PET+, then ABVD × 4 + BV consolidation | 3.9 | CR rate 95% | 3-year PFS 92% | 3-year OS 97% |
| BV - AVD19 | 117 | Stage I/II, unfavorable only | 32 | BV-AVD × 4 → PET If PET–, then 1. 30 Gy ISRT 2. 20 Gy ISRT 3. 30 consolidation volume radiotherapy 4. No radiotherapy | 3.8 | EOT CR rates for 4 cohorts 1. 93% 2. 100% 3. 93% 4. 97% | Overall 2-year PFS 94% 2-year PFS for 4 cohorts 1. 93.1% 2. 97% 3. 90% 4. 97% | Overall 2-year OS 99.1% |
| NIVAHL21 | 109 | Stage I/II, unfavorable only | 27 | 1. Nivo-AVD × 4 + 30 Gy ISRT 2. Sequential therapy: nivo × 4 doses → nivo-AVD × 2 → AVD × 2 + 30 Gy ISRT | 1.2 in group 1 and 1.1 group 2 | Group 1: ORR 100%, CR 83% Group 2: ORR 98%, CR 84% | 12-month PFS: Group 1: 100% Group 2: 98% | 12-month OS 100% in both groups |
| Sequential pembrolizumab and AVD22 | 30 | Stage I/II unfavorable only, stage III/IV | 29 | Pembro × 3 → AVD × 4-6 (4 cycles for early stage, 6 cycles for advanced stage or early-stage bulky) | 1.9 | CMR after pembro 37%, CMR after AVD 100%, EOT CMR 100% | Median PFS not reached, 2-year PFS 100% | Median OS not reached, 2-year OS 100% |
| Pembrolizumab and AVD23 | 30 | Stages I, II, III, IV | 32 | Pembro + AVD (2-6 cycles) | 0.86 | 68% PET2–, 78% EOT PET– | 1-year PFS 96% | 1-year OS 100% |
CMR, complete metabolic response.