Is allogeneic stem cell transplantation a solid option in R/R LBCL or R/R T-cell lymphoma?

The ASTRAL study suggests that allogeneic stem cell transplantation (alloSCT) may be a viable third- or fourth-line treatment option in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) and could be a preferred second-line therapy for patients with R/R T-cell lymphoma. Conditioning with fludarabine, thiotepa, and cyclophosphamide (FTC) was associated with reasonable organ toxicity.

The phase 2 ASTRAL study (NCT04121507) included participants with either R/R LBCL (n=42) or R/R T-cell lymphoma (n=18) to test a conditioning regimen of FTC followed by alloSCT. Participants were only included if a HLA 10/10-compatible donor was available. The primary endpoint was progression-free survival (PFS) at 12 months. Prof. Bertram Glass (Helios Klinikum Berlin-Buch, Germany) presented the results [1]. He mentioned that 52% of the participants had stage III or IV disease and that only 18% had an International Prognostic Index (IPI) score of 0. The median number of previously received therapies was 3.

The PFS rate at 1 year was 40% (95% CI 28–52), not meeting the primary endpoint of 50%. “With the censoring of 4 participants who died from COVID-19, a 2-year overall survival rate of 43% was achieved,” added Prof. Glass. Finally, an IPI score of 3–5 was associated with an increased risk of progressing compared with an IPI score of 0–2 (HR 2.5; 95% CI 1.2–5.3; P=0.012).

Infection was the most common grade 3–5 adverse event (AEs) (67%) until 14 weeks after alloSCT, followed by renal dysfunction (28%). Other apparent grade 3–5 AEs were central nervous system toxicity (13%) and vino-occlusive disease (8%). Grade 3 or 4 acute graft-versus-host-disease was reported in 19% and 11% of the participants, respectively, and the chronic variant in 30% of the participants.

“This study confirms the anti-lymphoma activity of alloSCT in heavily pre-treated participants with R/R B- or T-cell lymphoma,” expressed Prof. Glass. “However, ignoring the morbidity and mortality caused by COVID-19, non-relapse mortality is still higher in participants undergoing alloSCT than for those who are treated with CAR T-cell therapy or bi-specific antibodies.”

1. Glass B, et al. Results of the Astral Study: A Prospective Phase II Clinical Study of the German Lymphoma Alliance to Assess the Efficacy and Toxicity of High-Dose Chemotherapy Followed By Allogeneic Stem Cell Transplantation As Treatment of Primary Progressive and Relapsed Aggressive Non-Hodgkin Lymphoma. Abstract 231, 65^th ASH Annual Meeting, 9–12 December 2023, San Diego, CA, USA.

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Posted on 7 February 202419 February 2024