Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma

The aim of the trial is to improve disease control after an allogeneic stem cell transplantation (alloSCT) for relapsed or refractory classical Hodgkin lymphoma (rrHL, cHL) with consolidation therapy by Brentuximab Vedotin (BV) for up to one year.

The primary objective of the trial is to show efficacy of the experimental consolidative treatment strategy. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.

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Key information

Conditions

Classical Hodgkin Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with relapsed/refractory cHL who receive an allogeneic stem cell transplantation
Histologically proven cHL in the most recent tumor biopsy
Absolute neutrophil count ≥ 500/mm³
ECOG ≤2
Age ≥ 18 years

Exclusion criteria

Presence of nodular lymphocyte-predominant HL (NLPHL) or grey-zone lymphoma
Progressive disease as last documented response prior to alloSCT
Any peripheral neuropathy ≥ grade 2
Any other serious disease or organ dysfunction which might impair protocol treatment

Treatment and study plan

Brentuximab Vedotin

Drug

BV will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions

Other names: BV

Primary outcomes

1-year Cumulative incidence of relapse (CIR)

Time frame: 1 year

1-year Cumulative incidence of relapse (CIR)

Secondary outcomes

1- and 2-year Progression-free survival (PFS)

Time frame: 1 and 2 years

1- and 2-year Progression-free survival (PFS)

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2025
First posted: Aug 29, 2018
Registry last updated: Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed