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

Classical Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03652441
• Other study ID #: Uni-Koeln 3263
• Secondary ID: 2018-000873-59
• Status: Recruiting
• Phase: Phase 2
• Start date: November 13, 2019
• Est. completion date: August 2023

Study information

• Verified date: November 2020
• Source: University of Cologne
• Contact: Michael Fuchs
• Phone: +49221478
• Email: ghsg[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: August 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Classical Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
Germany	1st Department of Medicine, Cologne University Hospital	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year Cumulative incidence of relapse (CIR)	1-year Cumulative incidence of relapse (CIR)	1 year
Secondary	1- and 2-year Progression-free survival (PFS)	1- and 2-year Progression-free survival (PFS)	1 and 2 years