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Risks and benefits for patients with relapsed or refractory diffuse large B-cell lymphoma in early-phase clinical

Anne M Spanjaart1, Max Bakker1, Ralph de Vries2

  • 1Department of Hematology, Amsterdam University Medical Center, Location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands; LYMMCARE (Lymphoma and Myeloma Center Amsterdam), Amsterdam, Netherlands.

The Lancet. Haematology
|May 2, 2026
PubMed
Abstract

Insights

Since 2000, early-phase trials for relapsed or refractory diffuse large B-cell lymphoma show doubled response rates, mainly from cellular and bispecific antibody therapies. Safety outcomes remain favorable, with low treatment-related mortality.

Area of Science:

  • Hematology
  • Oncology
  • Clinical Trials

Background:

  • The treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) has evolved with novel therapies.
  • Many new drugs are approved based on early-phase trial data.

Purpose of the Study:

  • To evaluate antitumour activity and safety of drug classes in early-phase trials for relapsed or refractory DLBCL since 2000.
  • To establish benchmarks for clinicians, investigators, and regulators.

Main Methods:

  • Systematic review and meta-analysis of phase 1-2 trials (2000-2025).
  • Searched major databases (PubMed, Embase, Web of Science, Cochrane Library).
  • Pooled objective response rate (ORR) and complete response rate (CRR) using random-effects models; analyzed adverse events.

Main Results:

  • 132 trials with 7786 patients were included.
  • Overall ORR was 30.5% and CRR was 14.3%.
  • Cellular therapies (ORR 70.0%, CRR 51.0%) and bispecific antibodies (ORR 46.0%, CRR 30.0%) showed highest response rates.
  • Response rates increased over time; grade 3-4 adverse events occurred in 61.5% of patients.
  • Treatment-related mortality was low (0.6%).

Conclusions:

  • Early-phase trials for relapsed/refractory DLBCL demonstrate a significant increase in response rates since 2000.
  • Cellular and bispecific antibody therapies are key drivers of improved efficacy.
  • These findings provide crucial risk-benefit insights and contemporary benchmarks for managing DLBCL.

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