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Background <p>Bendamustine, etoposide, and busulfan (BEB) is a conditioning regimen used for autologous stem-cell transplantation (ASCT) in non-Hodgkin lymphoma (NHL). We investigated whether addition of melphalan (BEBM) could enhance this regimen.</p> Methods <p>BEBM with melphalan at 50, 70, or 100&#xa0;mg/m<sup>2</sup> was assessed in 12 high-risk or relapsed/refractory NHL patients (10 in complete response before ASCT) in a phase I 3 + 3 dose-escalation study. The primary endpoint was dose-limiting toxicity (DLT).</p> Results <p>All patients experienced grade ≥ 3 hematologic toxicities. Cohort 1 (50&#xa0;mg/m<sup>2</sup>) exhibited no grade ≥ 3 non-hematologic adverse events (AEs). Cohort 2 (70&#xa0;mg/m<sup>2</sup>, <i>n</i> = 6) exhibited two DLTs (grade 4 mucositis; one sepsis-related death). Cohort 3 (100&#xa0;mg/m<sup>2</sup>, <i>n</i> = 1) was prematurely terminated and had no severe non-hematologic AEs. The 3-month complete response rate was 90.9%. At a median follow-up of 57.5&#xa0;months, progression-free survival and overall survival rates were 58.3 and 66.7%.</p> Conclusion <p>BEBM demonstrated an acceptable safety profile, although significant toxicities were observed at 70&#xa0;mg/m<sup>2</sup>. While preliminary efficacy outcomes were encouraging, their interpretation is limited by the phase I design, small sample size, and premature termination of the highest-dose cohort. Larger prospective studies are warranted to further define the safety profile and evaluate the therapeutic potential.</p>

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Efficacy and safety of the BEBM (bendamustine, etoposide, busulfan, and melphalan) conditioning regimen for autologous stem-cell transplantation in non-Hodgkin lymphoma

  • 期刊论文

  • 发表日期：

    2026年8月5日

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  • Sang Hun Lee,
  • Do Young Kim,
  • Ho-Jin Shin

摘要

Background

Bendamustine, etoposide, and busulfan (BEB) is a conditioning regimen used for autologous stem-cell transplantation (ASCT) in non-Hodgkin lymphoma (NHL). We investigated whether addition of melphalan (BEBM) could enhance this regimen.

Methods

BEBM with melphalan at 50, 70, or 100 mg/m2 was assessed in 12 high-risk or relapsed/refractory NHL patients (10 in complete response before ASCT) in a phase I 3 + 3 dose-escalation study. The primary endpoint was dose-limiting toxicity (DLT).

Results

All patients experienced grade ≥ 3 hematologic toxicities. Cohort 1 (50 mg/m2) exhibited no grade ≥ 3 non-hematologic adverse events (AEs). Cohort 2 (70 mg/m2, n = 6) exhibited two DLTs (grade 4 mucositis; one sepsis-related death). Cohort 3 (100 mg/m2, n = 1) was prematurely terminated and had no severe non-hematologic AEs. The 3-month complete response rate was 90.9%. At a median follow-up of 57.5 months, progression-free survival and overall survival rates were 58.3 and 66.7%.

Conclusion

BEBM demonstrated an acceptable safety profile, although significant toxicities were observed at 70 mg/m2. While preliminary efficacy outcomes were encouraging, their interpretation is limited by the phase I design, small sample size, and premature termination of the highest-dose cohort. Larger prospective studies are warranted to further define the safety profile and evaluate the therapeutic potential.