Table 1 Summary of phase I, II and III trials and retrospective studies in Hodgkin Lymphoma.
From: Latest advances in the management of classical Hodgkin lymphoma: the era of novel therapies
Trial | Design | Study population | Study arms | Outcome |
|---|---|---|---|---|
Frontline | ||||
NU16H08 [74] | Phase II | > 18 years N = 30 | PEM followed by AVD | After PEM: 37%, CMR 25%, >90% decrease MTV on PET-CT After AVD: All, CMR |
NIVAHL [23] | Phase II | 18–60 years N = 110 | Arm A: Nivo+AVD x4 Arm B: Nivo x4 then Nivo+AVD x2 then AVD x2 | ORR: Arm A: 100%, B: 96% CR: Arm A: 81%, B: 86% 1-year PFS: 98% 1-year OS: 100% |
Trial of the LYSA group [28] | Phase II | > 60 years N = 89 | PVAB x6 | CMR: 77% 2-year OS: 84% 2-year PFS: 61% |
HD14 [12] | Randomized parallel arm trial | < 60 years Early stage, unfavourable N = 1112 | BEACOPP x2 then ABVD x2 Or ABVD x4 | 10-years PFS: 91.2 vs 85.6%, p < 0.0001 10-years OS: 94% vs 94.1 |
NCT01716806 [41] | Phase II | > 60 years N = 19 | BV + Nivo < 16 cycles | ORR: 100%, CR rate: 72%, PR rate: 28% |
Salvage therapy | ||||
Stamatoullas et al. [35] | Phase I/II | N = 42 | BV-ICE x2 then if CMR BV-ICE x1 then BV x1 then ASCT | CMR: 69.2%, PR: 25.6% 1-year PFS: 69% |
Herrera et al. [36] | Phase II | N = 39 | Nivo x6 If CR - > ASCT If no CR - > Nivo-ICE x2 | 1-year OS: 97% 1-year PFS: 79% |
Moskowitz et al. [37] | Phase II | N = 39 | PEM-GVHD x2-4 then ASCT | ORR: 100%, CR rate: 95%, PR rate: 5% No relapse or death (median follow-up 11.2 months) |
Phase I/II | ≥18 years N = 61 | BV + Nivo x4 +/- ASCT | ORR: 85%, CR: 67% 2-year PFS: 78% (if ASCT, 91%) 2-year OS: 93% | |
LaCasce [38] | Phase I/II | N = 53 | BvB <6 cycles then ASCT or BV x14 | CR: 95% (if ASCT, 94%) 2-year PFS: 69.8% (if ASCT, 63%) |
Checkmate 205 [75] | Phase II | N = 276 | Nivo after ASCT Cohort A: BV naïve N = 60 Cohort B: Failure of BV post-ASCT N = 60 Cohort C: After BV before and/or after ASCT failure | ORR/CR: Overall: 69%/16% Cohort A: 65%/29% Cohort B: 68%/13% Cohort C: 73%/12% Median PFS: Overall: 14.7 m Cohort A: 18.3 m Cohort B: 14.7 m Cohort C: 11.9 m |
Primary refractory disease | ||||
KEYNOTE-024 [58] | Phase III | ≥18 years N = 304 | PEM vs BV | mPFS: 13.2 vs 8.3 m |
CPI before allo-HCT | ||||
Retrospective | Pts treated with anti-PD1 mAb before transplant N = 150 | TT: Nivo N = 118, PEM N = 31, avelumab N = 1 Transplant: Haplo (47%), MSD (19%), MUD (26%), MMUD (5%), CB (1%), unknown (1%) | 2-year PFS: 65% 2-year OS: 79% 2-year NRM: 14% 6-m CI of grade 2-4 aGVHD: 39% 6-m CI of grade 3-4 aGVHD: 16% 2-year CI of cGVHD: 45% | |
Manson et al. [62] | Retrospective | Pts treated with Nivo with a cohort of allo-SCT N = 17 | TT: Nivo Transplant | 1-year PFS: 76% 1-year OS: 82% 1-year TRM: 17.6% Grade 2-4 aGVHD: 82% cGVHD: 29% |
El Cheikh et al. [77] | Retrospective | Nivo followed by allo-SCT N = 9 | TT: Nivo N = 9 Transplant: Haplo (67%) MSD (33%) | Grade 2-4 aGVHD: 100% cGVHD: 33% |
CPI for relapse after allo-HCT | ||||
Herbaux et al. [69] | Retrospective | Relapse after allo-SCT N = 20 | Nivo | ORR: 95%, CR: 42%, PR: 52% 1-year PFS: 58% 1-year OS:79% GvHD: 30% of pts |
Haverkos et al. [70] | Retrospective | Relapse after allo-SCT N = 31 | Nivo or PEM | GvHD: 55% of pts (59% aGvHD, 41% cGvHD) |
Ibrutinib for relapse after allo-SCT | ||||
Badar et al. [71] | Retrospective | ≥18 years N = 7 | Ibrutinib | ORR: 57%, CR: 43%, PR: 14% |
