Select studies evaluating role of alloHCT in Philadelphia chromosome-positive acute lymphoblastic leukemia in first complete remission
| Study . | Pre-alloHCT regimen . | Population (# in CR1, age, transplant allocation) . | Outcomes (alloHCT vs no) . |
|---|---|---|---|
| GRAALL(SAKK) GRAAPH-20059 NCT00327678 | IM, chemotherapy | n = 254; 18-59 yrs Transplant allocation: 161 allo, 35 auto, 58 no transplant | OS HR 0.64, p = 0.02 RFS HR 0.69, p = 0.04 In MR4 at MRD2: RFS HR 1.02, p = 0.96 Not in MR4 at MRD2: RFS HR 0.62, p = 0.03 |
| GRAALL(SAKK) GRAAPH-201428 NCT02611492 | NIL, chemotherapy | n = 155; 18-59 yrs Transplant allocation: 93 allo, 40 auto, 22 no transplant | alloHCT associated with longer RFS (4-yr 79.4%) vs auto (57.2%; HR 0.46, p = 0.018) and vs no transplant (32.0%, HR 0.17, p < 0.0001) By randomization: Similar results in arm B (low-intensity consolidation), but improved RFS after alloHCT not seen in arm A (high-intensity consolidation) |
| KAALLWP(Korea) NCT0084429830 | NIL, chemotherapy | n = 82; 17-71 yrs Transplant allocation: allo 57, no allo 25 | OS 80% vs 72%, p = 0.23 RFS 78% vs 49%, p = 0.045 CIR 19% vs 41%, p = not reported NRM 19% vs 20%, p = not significant In MR5: RFS 65% vs 53%, p = 0.78 Multivariable analysis: alloHCT (HR 3.3, p = 0.048) and achievement of MR3 (HR 12.3, p = 0.038) associated with 2-yr RFS |
| SWOG (US) SWOG 080531 NCT00792948 | DAS, hyper-CVAD | n = 85; 20-60 yrs Transplant allocation: 41 protocol- specified allo; 44 no protocol-specified allo (8 nonprotocol allo) | Received protocol-specified: RFS 83% (12 mo); 76% (3 yr) Landmark analysis (175 days): protocol allo associated with improved RFS (HR 0.42, p = 0.038 and OS HR 0.35, p = 0.037) |
| Retrospective US (5 transplant centers)32 | IM, DAS, PON, chemo (mostly IM/DAS plus hyper-CVAD) | n = 230 all in MR4 by 3 months; 19-73 yrs Transplant allocation: 98 allo; 132 non-allo | OS (5 yr): 58% vs 61% (p = 0.63) RFS (5 yr): 63% vs 52% (p = 0.42) CIR (5 yr): 15% vs 36% (p = 0.001) NRM (5 yr): 21% vs 11% (p = 0.06) GRFS (5 yr): 25% vs 52% (p = 0.0001) |
| JALSG(Japan)33 Ph+ALL202, Ph+ALL208, Ph+ALL213 | IM, DAS plus chemo | n = 147 all in MR5 by 3 mos; 15-64 yrs Transplant allocation: 101 allo; 46 non-allo | OS (5 yr): 73% vs 50% (aHR 0.54, p = 0.04) RFS (5 yr): 70% vs 20% (aHR 0.21, p < 0.001) CIR (5 yr): 14% vs 73% (aHR 0.10, p < 0.001) NRM (5 yr): 17% vs 5% (aHR 3.49, p = 0.03) GRFS (5 yr): 50% vs 20% (p = NS) |
| Study . | Pre-alloHCT regimen . | Population (# in CR1, age, transplant allocation) . | Outcomes (alloHCT vs no) . |
|---|---|---|---|
| GRAALL(SAKK) GRAAPH-20059 NCT00327678 | IM, chemotherapy | n = 254; 18-59 yrs Transplant allocation: 161 allo, 35 auto, 58 no transplant | OS HR 0.64, p = 0.02 RFS HR 0.69, p = 0.04 In MR4 at MRD2: RFS HR 1.02, p = 0.96 Not in MR4 at MRD2: RFS HR 0.62, p = 0.03 |
| GRAALL(SAKK) GRAAPH-201428 NCT02611492 | NIL, chemotherapy | n = 155; 18-59 yrs Transplant allocation: 93 allo, 40 auto, 22 no transplant | alloHCT associated with longer RFS (4-yr 79.4%) vs auto (57.2%; HR 0.46, p = 0.018) and vs no transplant (32.0%, HR 0.17, p < 0.0001) By randomization: Similar results in arm B (low-intensity consolidation), but improved RFS after alloHCT not seen in arm A (high-intensity consolidation) |
| KAALLWP(Korea) NCT0084429830 | NIL, chemotherapy | n = 82; 17-71 yrs Transplant allocation: allo 57, no allo 25 | OS 80% vs 72%, p = 0.23 RFS 78% vs 49%, p = 0.045 CIR 19% vs 41%, p = not reported NRM 19% vs 20%, p = not significant In MR5: RFS 65% vs 53%, p = 0.78 Multivariable analysis: alloHCT (HR 3.3, p = 0.048) and achievement of MR3 (HR 12.3, p = 0.038) associated with 2-yr RFS |
| SWOG (US) SWOG 080531 NCT00792948 | DAS, hyper-CVAD | n = 85; 20-60 yrs Transplant allocation: 41 protocol- specified allo; 44 no protocol-specified allo (8 nonprotocol allo) | Received protocol-specified: RFS 83% (12 mo); 76% (3 yr) Landmark analysis (175 days): protocol allo associated with improved RFS (HR 0.42, p = 0.038 and OS HR 0.35, p = 0.037) |
| Retrospective US (5 transplant centers)32 | IM, DAS, PON, chemo (mostly IM/DAS plus hyper-CVAD) | n = 230 all in MR4 by 3 months; 19-73 yrs Transplant allocation: 98 allo; 132 non-allo | OS (5 yr): 58% vs 61% (p = 0.63) RFS (5 yr): 63% vs 52% (p = 0.42) CIR (5 yr): 15% vs 36% (p = 0.001) NRM (5 yr): 21% vs 11% (p = 0.06) GRFS (5 yr): 25% vs 52% (p = 0.0001) |
| JALSG(Japan)33 Ph+ALL202, Ph+ALL208, Ph+ALL213 | IM, DAS plus chemo | n = 147 all in MR5 by 3 mos; 15-64 yrs Transplant allocation: 101 allo; 46 non-allo | OS (5 yr): 73% vs 50% (aHR 0.54, p = 0.04) RFS (5 yr): 70% vs 20% (aHR 0.21, p < 0.001) CIR (5 yr): 14% vs 73% (aHR 0.10, p < 0.001) NRM (5 yr): 17% vs 5% (aHR 3.49, p = 0.03) GRFS (5 yr): 50% vs 20% (p = NS) |
aHR, adjusted hazard ratio; allo, allogeneic hematopoietic stem cell transplant; chemo, chemotherapy; CIR, cumulative incidence of relapse; CMR, complete molecular remission; CR, complete remission; DAS, dasatinib; GRFS, GVHD relapse-free survival; HR, hazard ratio; IM, imatinib; mo, month; NIL, nilotinib; NRM, nonrelapse mortality; OS, overall survival; PON, ponatinib; RFS, relapse-free survival; SAKK (France, Belgium, and Switzerland); US, United States; year, yr.