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

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cologne
• Treatments: Antibodies, Monoclonal; Brentuximab Vedotin

Criteria

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