TABLE 5.
Trials of total marrow irradiation (TMI) and total marrow and lymphoid irradiation (TMLI) for acute leukemia
| Trial | Number of patients | Treatment | Patients | Median follow‐up | Dose fractionation | Dose per fraction (Gy) | Chemotherapy | NRM/OS | |
|---|---|---|---|---|---|---|---|---|---|
| Rosenthal et al, 2011 18 | Phase I/II | 61 | TMLI | RIC | 13.1 months |
12 Gy in 8 (twice daily) |
1.5 | Flu + Mel |
1‐year NRM 8.1% 1‐year OS 75% |
| Jensen et al, 2018 26 | Prospective | 61 | TMLI | RIC | 7.4 years |
12 Gy in 8 (twice daily) |
1.5 | Flu + Mel |
5‐year NRM 33% 5‐year OS 42% |
| Wong et al, 2013 13 |
Phase I/ phase I |
12/20 | TMLI |
MAC (non‐CR) |
14.75 months/ 7.3 months |
12–15Gy in 8–10 (twice daily) |
1.5 |
CY + VP16/ BU + VP16 |
100‐day NRM 8%/20% Death 6/15 |
| Patel et al, 2014 14 | Phase I | 14 | TMI |
MAC (high‐risk) |
37.0 months |
3–12 Gy in 2–8 (twice daily) |
1.5 | Flu + BU |
TRM 29% OS 50% |
| Hui et al, 2017 15 | Phase I | 12 | TMI |
MAC (refractory/MRD) |
3.3 months |
15–18 Gy in 5–6 (once daily) |
3 | CY + Flu |
1‐year NRM 42% 1‐year OS 42% |
| Stein et al, 2017 11 | Phase I | 51 | TMLI | MAC (relapse/refractory) | 24.6 months |
12–20 Gy in 10 (twice daily) |
1.5–2 | CY + VP16 |
100‐day NRM 3.9% 1‐year OS 55.5% |
| Shi et al, 2021 16 | Retrospective | 61 | TMLI | MAC | N/A |
8 Gy in 2 (twice daily) |
4 | N/A |
2‐year NRM 5% 2‐year OS 74.7% |
| Current study | Phase I | 9 | TMLI |
MAC (CR/CP/MRD) |
18.9 months |
14–18 Gy in 6 (twice daily) |
2.33–3 | CY |
NRM 0% 1‐year OS 83.3% |
Abbreviations: BU, busulfan; CP, chronic phase; CR, complete remission; CY, cyclophosphamide; Flu, fludarabine; MAC, myeloablative conditioning; Mel, melphalan; MRD, measurable residual disease; N/A, not available; NRM, nonrelapse mortality; OS, overall survival; RIC, reduced‐intensity conditioning; TRM, treatment‐related mortality; VP16, etoposide.