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

University of Cologne21 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Classical Hodgkin Lymphoma

Interventions

Brentuximab VedotinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

RECRUITING

Outcomes

Primary Outcomes

1-year Cumulative incidence of relapse (CIR)

Time frame: 1 year

Secondary Outcomes

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

Time frame: 1 and 2 years

Central Contacts

Michael Fuchs

CONTACT

+49221478 ghsg@uk-koeln.de

Data from ClinicalTrials.gov

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