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

NCT03652441 | Completed Phase 2 DMC

• 2 other identifiers: Uni-Koeln 32632018-000873-59
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Classical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• 1-year Cumulative incidence of relapse (CIR)

  1-year Cumulative incidence of relapse (CIR)

  1 year

Secondary Outcomes (1)

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

  1 and 2 years

Study Arms (1)

Maintenance

EXPERIMENTAL

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

Drug: Brentuximab Vedotin

Interventions

Brentuximab Vedotin DRUG

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

Also known as: BV

Maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

Location

MeSH Terms

Interventions

Brentuximab Vedotin

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Christof Scheid, Prof.

  University of Cologne, I. Dept. of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Stem Cell Transplantation

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 29, 2018
• Study Start: November 13, 2019
• Primary Completion: August 10, 2023
• Study Completion: January 25, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

DE (1)