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

University of Cologne

Status and phase: Unknown; Phase 2

Conditions: Classical Hodgkin Lymphoma

Treatments: Drug: Brentuximab Vedotin

Study type: Interventional

Funder types: Other

Identifiers

NCT03652441

Uni-Koeln 3263

2018-000873-59 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Maintenance

Experimental group

Description:

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

Treatment:

Drug: Brentuximab Vedotin