Table 2.
Studies on alloHCT for DLBCL
| EBMT 2011 (16) | GITMO 2012 (17) | CIBMTR 2013 (84) MAC/RIC | CIBMTR 2016 (3) | EBMT 2010-R-12 (18) MAC / RIC | CIBMTR/EBM T LY16-03 (20) MRD / MUD TCD+ / MUD TCD-/haplo | DSHNHL 2004-R3 NCT007853 30 (26) | |
|---|---|---|---|---|---|---|---|
| Study type | Registry retrospective | Registry retrospective | Registry retrospective | Registry retrospective | Registry retrospective | Registry retrospective | Phase 2 Prospective |
| Indication | autoHCT failure | autoHCT failure | Refractory disease | autoHCT failure | DLBCL,alloHCT as 1st HCT (prior autoHCT excluded) | DLBCL, 1st alloHCT (prior autoHCT permitted) | PIF, early relapse, autoHCT failure |
| N | 101 | 165 | 533 (incl.80 FL3) | 503 | 132 / 98 | 1306 525 / 403 / 378/132 | 84* |
| Period | 1997–2006 | 1995–2008 | 1998–2010 | 2000–2012 | 2002–2010 | 2008–2015 | 2004–2009 |
| Age (years; median (range)) | 46 (19–66) | 43 (16–65) | 46 (19–66) / 53 (20-70) | 52 (19–72) | 42 (31–50) / 52 (43-57) | 55 (19–75) | 48 (38–57) |
| PS >1 (ECOG) or <90% (Karnofsk y) | 2% | n.a. | n.a. | 10% § | 16% / 19% | 38%/38%/43%/27% | 8%§ |
| Prior autoHCT | 100% | 100% | 15% / 38% | 100% | 0% | 55%/59%/61%/42% | 46% |
| Disease status refractory | 26% | 33% | 100% | 21% | 46% / 32% | 21%/18%/17%/17% | 55% |
| Unrelated donor | 29% | 35% | 34% / 53% | 50% | 37% / 34% | 0%/100%/100%/0% | 57% |
| Conditioning regimen RIC or NMA | 64% | 70% | 43% | 100% | 0% / 100% | 100% | 0% |
| Nonrelapse mortality | 16% | n.a. | 38% / 25% | 12% | 10% / 5% | n.a. | 12% |
| 100 | 25% | 23% | 20% / 16% | 13%/21%/20%/16% | 35% | ||
| d | 28% | 47% / 36% | 30% | ||||
| 1y 3y |
53% / 42% | 23% / 17% | 17%/26%/30%/22% | ||||
| Relapse incidence | 27% / | 46% / | 39%/33%/28%/3 | ||||
| 1y | 24% | n.a. | 32% | 33% | 46% | 4% | 29% |
| 3y | 30% | 28% / 35% | 38% | 47% / 51% | 47%/38%/34%/4 1% | 29% | |
| Progressi on-free survival | 52% | 48% | 26% / 32% | 44% | 34% / 38% | 48%/46%/52%/50% | 45% |
| 1y | 42% | 34% | 31% | 39% | |||
| 3y | 23% | 27% | 19% / 23% | HR 2.04 (vs CR) | 30% / 33% | 37%/36%/37%/38% | |
| 3y | 19% / 23% | n.a. | |||||
| (if refractory at HCT) | |||||||
| Overall survival | |||||||
| 1y | 65% | 55% | 31% / 42% | 54% | 39% / 50% | 65%/56%/63%/66% | 52% |
| 3y | 52% | 42% | 19% / 28% | 37% | 32% / 40% | 50%/43%/46%/46% | 42% |
| Risk factors for PFS/OS | Time to rel after auto <12mo / = | Time to rel after auto <12mo / Refractory at HCT, MUD | DLBCL (vs FL3) | Refractory at HCT, poor PS, MAC / Refractory at HCT, poor PS, MAC, Time auto_allo <12mo | n.a. | Refractory at HCT, poor PS / Refractory at HCT, poor PS, age, HCT-CI | n.a. / refractory at HCT, no ATG, >4 lines of pretreatme nt, mismatche d donor |
| Grade 2-4 (3-4) acute GVHD | 33% (n.a.) | 29% (10%) | 29% / 31% | 36% (15%) | n.a. | 32%/32%/42%/34% (11%/13%/19%/7%) |
30% (n.a.) |
| Extensive chronic GVHD | 17% | n.a. | n.a. | 33% | n.a. | n.a. | 33%-41% (3y) |
| 1y | |||||||
| Follow-up (months) | 36 (3–112) | 39 (1–144) | 35 / 30 | 55 (11–49) | 36 (9–68) | 49 (12–73) | 48 (29–71) |
*
includes 27% patients with T cell lymphoma
§
Karnofky <80%
ATG, anti-thymocyte globuline; DLBCL, diffuse large B-cell lymphoma; GVHD, graft-versus-host disease; HCT-CI, hematopoietic cell transplantation comorbidity index; MAC, myeloablative conditioning; MUD, matched unrelated donor, n.a., not available; PS, performance status; RIC, reduced intensity conditioning; TCD, T-cell depletion