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

Last updated: November 26, 2020
Sponsor: University of Cologne
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Treatment

N/A

Clinical Study ID

NCT03652441
Uni-Koeln 3263
2018-000873-59
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 Design

Total Participants: 21
Study Start date:
November 13, 2019
Estimated Completion Date:
August 31, 2023

Connect with a study center

  • 1st Department of Medicine, Cologne University Hospital

    Cologne,
    Germany

    Active - Recruiting

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