A trial to improve disease control after an allogeneic stem cell transplantation for relapsed or refractory classical Hodgkin lymphoma with consolidation therapy by Brentuximab Vedotin

Consolidation Therapy with Brentuximab Vedotin after Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma - BV-ALLO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000873-59-DE

Enrollment

Registered

2018-06-12

Start date

2019-06-13

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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) MedDRA version: 20.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Trade Name: Adcetris Product Name: Adcetris Pharmaceutical Form: Lyophilisate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? - Presence of nodular lymphocyte-predominant HL (NLPHL) - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.;Primary end point(s): 1-year Cumulative incidence of relapse (CIR);Timepoint(s) of evaluation of this end point: refer to E.5.1	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.;Primary end point(s): 1-year Cumulative incidence of relapse (CIR);Timepoint(s) of evaluation of this end point: refer to E.5.1

—

Secondary

Measure	Time frame
Secondary end point(s): - 1- and 2-year Progression-free survival (PFS) - 1- and 2-year Overall survival (OS) - Incidence of non-relapse Mortality - Overall response rate (ORR) - Best response - Incidence and severity of acute and chronic Graft-versus-host disease (GvHD) - Adverse events (AE) - Quality of life (QoL) and life situation (LS) aspects - Correlative scientific studies	—

Countries

Germany

Contacts

Public ContactTrial Coordination Center (TCC)

German Hodgkin Study Group

ghsg@uk-koeln.de004922147888200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026