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.

Study Overview

• Status: Completed
• Conditions: Classical Hodgkin Lymphoma
• Intervention / Treatment: Drug: Brentuximab Vedotin

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany
    • 1st Department of Medicine, Cologne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maintenance; Brentuximab Vedotin will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions	Drug: Brentuximab Vedotin; BV will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions; Other Names: BV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year Cumulative incidence of relapse (CIR)	1-year Cumulative incidence of relapse (CIR)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1- and 2-year Progression-free survival (PFS)	1- and 2-year Progression-free survival (PFS)	1 and 2 years

Collaborators and Investigators

• Sponsor: University of Cologne
• Investigators: Principal Investigator: Christof Scheid, Prof., University of Cologne, I. Dept. of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): January 25, 2025

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Brentuximab Vedotin
• Other Study ID Numbers: Uni-Koeln 3263; 2018-000873-59 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No