Characteristics of patients treated in the adjuvant arm
| Never relapsed after HCT . | . | . | ||||||
|---|---|---|---|---|---|---|---|---|
| ID . | Donor . | DL . | Age/sex . | Adverse-risk features . | Prior treatments . | Time to T cells after HCT (in days) . | Donor chimerisms (blood or marrow), % . | Ongoing tacrolimus on day of infusion . |
| 1 | MRD | 1 | 57/F | FLT3-ITD | CIA→sorafenib→CIAx2→RIC-HCT | 117 | 100 | Yes |
| 2 | MRD | 1 | 18/F | FLT3-ITD | AAML 1031 (arm C-sorafenib)→MAC-HCT | 155 | 90 | Yes |
| 3 | MRD | 1 | 55/F | MLL-r | 7+3→HiDAC→MAC-HCT | 76 | 100 | Yes |
| 5 | MRD | 2 | 53/F | DNMT3A mut | 7+3→HiDAC→MAC-HCT | 63 | 100 | Yes |
| 8 | MRD | 2 | 65/M | MLL-r | 7+3×2→5-Azax11→RIC-HCT | 156 | 100 | Yes |
| 9 | MRD | 3 | 45/M | Ph+AML | 7+3+Imatinib→MAC-HCT | 106 | 100 | yes |
| 10 | MRD | 3 | 51/F | AML CR2 | 7+3→HiDAC→relapse→FLA→HiDAC→MAC-HCT | 106 | 100 | Yes |
| 4 | MRD | 1 | 54/F | Complex-rIPSS: Int-2 | 5-Azax11→transf-dep→RIC-SCT | 66 | 100 | Yes |
| 11 | MRD | 3 | 53/F | CR2 (MRD+ at HCT) | 7+3→HiDAC→relapse→FLA→ MRD+→MAC-HCT | 112 | 100 | None |
| 14 | MRD | 3 | 18/F | FLT3-ITD (MRD+ at HCT) | AAML1031→relapse→CPX-351→FLA(G)→Ara-C/peg/midostaurin→refractory→venetoclax/decitabine→MRD+→MAC-HCT | 132 | 100 | Unknown |
| 13 | MRD | 3 | 26/M | TP53 mut MDS-EB2 | 5-aza+ venetoclax→MAC-HCT | 132 | 100 | Yes |
| 15 | MUD | 5 | 67/M | CMML→AMML (PIF) | 7+3→residual disease→venetoclax+5-aza→RIC-HCT | 230 | 91 | None |
| Never relapsed after HCT . | . | . | ||||||
|---|---|---|---|---|---|---|---|---|
| ID . | Donor . | DL . | Age/sex . | Adverse-risk features . | Prior treatments . | Time to T cells after HCT (in days) . | Donor chimerisms (blood or marrow), % . | Ongoing tacrolimus on day of infusion . |
| 1 | MRD | 1 | 57/F | FLT3-ITD | CIA→sorafenib→CIAx2→RIC-HCT | 117 | 100 | Yes |
| 2 | MRD | 1 | 18/F | FLT3-ITD | AAML 1031 (arm C-sorafenib)→MAC-HCT | 155 | 90 | Yes |
| 3 | MRD | 1 | 55/F | MLL-r | 7+3→HiDAC→MAC-HCT | 76 | 100 | Yes |
| 5 | MRD | 2 | 53/F | DNMT3A mut | 7+3→HiDAC→MAC-HCT | 63 | 100 | Yes |
| 8 | MRD | 2 | 65/M | MLL-r | 7+3×2→5-Azax11→RIC-HCT | 156 | 100 | Yes |
| 9 | MRD | 3 | 45/M | Ph+AML | 7+3+Imatinib→MAC-HCT | 106 | 100 | yes |
| 10 | MRD | 3 | 51/F | AML CR2 | 7+3→HiDAC→relapse→FLA→HiDAC→MAC-HCT | 106 | 100 | Yes |
| 4 | MRD | 1 | 54/F | Complex-rIPSS: Int-2 | 5-Azax11→transf-dep→RIC-SCT | 66 | 100 | Yes |
| 11 | MRD | 3 | 53/F | CR2 (MRD+ at HCT) | 7+3→HiDAC→relapse→FLA→ MRD+→MAC-HCT | 112 | 100 | None |
| 14 | MRD | 3 | 18/F | FLT3-ITD (MRD+ at HCT) | AAML1031→relapse→CPX-351→FLA(G)→Ara-C/peg/midostaurin→refractory→venetoclax/decitabine→MRD+→MAC-HCT | 132 | 100 | Unknown |
| 13 | MRD | 3 | 26/M | TP53 mut MDS-EB2 | 5-aza+ venetoclax→MAC-HCT | 132 | 100 | Yes |
| 15 | MUD | 5 | 67/M | CMML→AMML (PIF) | 7+3→residual disease→venetoclax+5-aza→RIC-HCT | 230 | 91 | None |
| Relapsed after HCT, but in CR after salvage therapy . | . | . | ||||||
|---|---|---|---|---|---|---|---|---|
| ID . | Donor . | DL . | Age/sex . | Adverse-risk features . | Prior treatments . | Time to relapse after HCT (in days) . | Donor chimerisms (blood or marrow), % . | Ongoing tacrolimus on day of infusion . |
| 6 | MRD | 2 | 70/F | AML CR3 | 7+3→HiDAC→CIA→RIC-HCT-relapse→7+3 | 800 | 100 | None |
| 12 | MRD | 3 | 55/M | Ph+, t-AML | 7+3→RIC-HCT→relapse→7+3 | 2130 | 100 | None |
| 7 | MRD | 2 | 58/M | RAEB-1 rIPSS: Int-2→t-AML in CR2 | Decitabine→RIC-HCT→relapse with RAEB→CIA→relapse as MDS→DLI (×4) | 356 | 100 | None |
| 9 | MRD | 4 | 47/M | Ph+AML in CR2 | 7+3+Imatinib→MAC-HCT→mLST→molecular relapse→decitabine-dasatinib | 460 | 100 | None |
| 6 | MRD | 4 | 73/F | AML CR5 | 7+3→HiDAC→IA→RIC-HCT-relapse→7+3→mLST→relapse→IT chemo and XRT→relapse→IT chemo and XRT | 1330 | 100 | None |
| Relapsed after HCT, but in CR after salvage therapy . | . | . | ||||||
|---|---|---|---|---|---|---|---|---|
| ID . | Donor . | DL . | Age/sex . | Adverse-risk features . | Prior treatments . | Time to relapse after HCT (in days) . | Donor chimerisms (blood or marrow), % . | Ongoing tacrolimus on day of infusion . |
| 6 | MRD | 2 | 70/F | AML CR3 | 7+3→HiDAC→CIA→RIC-HCT-relapse→7+3 | 800 | 100 | None |
| 12 | MRD | 3 | 55/M | Ph+, t-AML | 7+3→RIC-HCT→relapse→7+3 | 2130 | 100 | None |
| 7 | MRD | 2 | 58/M | RAEB-1 rIPSS: Int-2→t-AML in CR2 | Decitabine→RIC-HCT→relapse with RAEB→CIA→relapse as MDS→DLI (×4) | 356 | 100 | None |
| 9 | MRD | 4 | 47/M | Ph+AML in CR2 | 7+3+Imatinib→MAC-HCT→mLST→molecular relapse→decitabine-dasatinib | 460 | 100 | None |
| 6 | MRD | 4 | 73/F | AML CR5 | 7+3→HiDAC→IA→RIC-HCT-relapse→7+3→mLST→relapse→IT chemo and XRT→relapse→IT chemo and XRT | 1330 | 100 | None |
All patients were in morphological CR and with no detectable disease on preinfusion flow cytometry or genetic analysis. Bold, italicized text highlights major events during the course of the patient's disease.
5-aza, 5 azacytidine; 7+3, 7 d of cytarabine infusion and 3 d of idarubicin; AAML 1031, up-front pediatric treatment protocol; Ara-C, cytarabine; CIA, clofarabine, idarubicin, and cytarabine; CMML→AMML, acute converted from chronic myelomonocytic leukemia; DNMT3A mut, DNA methyltransferase, 3A mutation; F, female; FLA(G), fludarabine and cytarabine with G-CSF; FLT3-ITD, fms-like tyrosine kinase 3 receptor1-internal tandem duplication; HiDAC, high dose (>1 g/m2 cytarabine), ID, patient ID number; Int-2, intermediate-2; IT chemo, intrathecal chemotherapy only; M, male; MAC, fully myeloablative pre-HCT conditioning chemotherapy; MDS-EB2, myelodysplastic syndrome-excess blasts-2; MLL-r, mixed lineage leukemia-1 gene rearrangement; MRD+, measurable residual disease present; Peg, pegasparaginase; Ph+, Philadelphia chromosome–positive (BCR-ABL rearranged); PIF, primary induction failure; RAEB, refractory anemia with excess of blasts; RIC, reduced-intensity pre-HCT conditioning chemotherapy; rIPSS, revised International Prognostic System for MDS; t-AML, therapy-related AML; TP53 mut, mutated TP53 gene, XRT, radiotherapy.