Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma
- Registration Number
- NCT03652441
- Lead Sponsor
- University of Cologne
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 21
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Maintenance Brentuximab Vedotin Brentuximab Vedotin will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions
- Primary Outcome Measures
Name Time Method 1-year Cumulative incidence of relapse (CIR) 1 year 1-year Cumulative incidence of relapse (CIR)
- Secondary Outcome Measures
Name Time Method 1- and 2-year Progression-free survival (PFS) 1 and 2 years 1- and 2-year Progression-free survival (PFS)
Trial Locations
- Locations (1)
1st Department of Medicine, Cologne University Hospital
🇩🇪Cologne, Germany