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. 2025 Jan;114(1):79-88.
doi: 10.1111/ejh.14305. Epub 2024 Sep 19.

Comparable Results Between 8 and 12 Gray TBI in Combination With Fludarabine and Post-Transplant Cyclophosphamide in MRD-Negative but Not in MRD-Positive Acute Lymphoblastic Leukemia Patients Transplanted in First Complete Remission

Normann Steiner  1   2 , Radwan Massoud  1 , Johanna Richter  1 , Tetiana Perekhrestenko  1   3 , Nico Gagelmann  1 , Christian Niederwieser  1 , Kristin Rathje  1 , Iryna Lastovytska  1 , Mathias Schäfersküpper  1 , Silke Heidenreich  1 , Ina Rudolph  1 , Gaby Zeck  1 , Dietlinde Janson  1 , Christine Wolschke  1 , Francis Ayuketang Ayuk  1 , Evgeny Klyuchnikov  1 , Nicolaus Kröger  1
Affiliations

Comparable Results Between 8 and 12 Gray TBI in Combination With Fludarabine and Post-Transplant Cyclophosphamide in MRD-Negative but Not in MRD-Positive Acute Lymphoblastic Leukemia Patients Transplanted in First Complete Remission

Normann Steiner et al. Eur J Haematol. 2025 Jan.

Abstract

Background: The optimal TBI dose for ALL patients undergoing allogeneic SCT is still not clearly defined.

Methods: Single-center retrospective analysis of high-risk ALL patients in CR1 treated with 8 Gy (n = 22) or 12 Gy (n = 50) TBI in combination with fludarabine and PTCy. Median patient age in the 8 Gy TBI cohort was 63 (37-79) and 37 (18-56) in the 12 Gy TBI cohort and median follow-up time was 21 months (range 1-92).

Results: OS and LFS at 2 years after 8 Gy were 65% and 55% versus 74% and 74% after 12 Gy (p = 0.3 and p = 0.2, respectively). CIR and NRM at 2 years were 27% and 14% after 8 Gy versus 4% and 20% after 12 Gy (p = 0.004 and p = 0.4, respectively). MRD-positive (+) patients (n = 26) receiving 12 Gy (n = 19) showed better OS (p = 0.01), LFS (p = 0.009), GRFS, lower CIR (p = 0.02), and similar NRM than did MRD+ patients receiving 8 Gy (n = 7). MRD-negative (-) patients (n = 38) receiving 12 Gy (n = 27) had similar OS, LFS, GRFS, lower CIR, and higher NRM (p = 0.04) than did MRD- patients receiving 8 Gy (n = 11).

Conclusion: Our study demonstrates that 8 Gy TBI in comparison to 12 Gy TBI results in low NRM but a high relapse rate with similar OS, LFS, and GRFS. In MRD+ high-risk ALL patients, allogeneic SCT with 12 Gy TBI leads to improved OS, LFS, GRFS, and a low relapse rate. Prospective studies comparing the different treatment regimens with larger MRD patient cohorts are needed to confirm this data.

Keywords: 12 Gy TBI; 8 Gy TBI; PTCy; acute lymphoblastic leukemia; allogeneic stem cell transplantation.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Overall survival after alloSCT for MRD‐positive (+) and negative (−) ALL patients treated with 8 Gy TBI or 12 Gy TBI.
FIGURE 2
FIGURE 2
Leukemia‐free survival after alloSCT for MRD‐positive (+) and negative (−) ALL patients treated with 8 Gy TBI or 12 Gy TBI.
FIGURE 3
FIGURE 3
Non‐relapse mortality after alloSCT for MRD‐positive (+) and negative (−) ALL patients treated with 8 Gy TBI or 12 Gy TBI.
FIGURE 4
FIGURE 4
Cumulative incidence of relapse after alloSCT for MRD‐positive (+) and negative (−) ALL patients treated with 8 Gy TBI or 12 Gy TBI.
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