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

Sponsor
University of Cologne (Other)
Overall Status
Recruiting
CT.gov ID
NCT03652441
Collaborator
(none)
21
Enrollment
1
Location
1
Arm
44.6
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Brentuximab Vedotin
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma
Actual Study Start Date :
Nov 13, 2019
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Maintenance

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

Drug: Brentuximab Vedotin
BV will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions
Other Names:
  • BV
  • Outcome Measures

    Primary Outcome Measures

    1. 1-year Cumulative incidence of relapse (CIR) [1 year]

      1-year Cumulative incidence of relapse (CIR)

    Secondary Outcome Measures

    1. 1- and 2-year Progression-free survival (PFS) [1 and 2 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    11st Department of Medicine, Cologne University HospitalCologneGermany

    Sponsors and Collaborators

    • University of Cologne

    Investigators

    • Principal Investigator: Christof Scheid, Prof., University of Cologne, I. Dept. of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christoph Scheid, Head of Stem Cell Transplantation, University of Cologne
    ClinicalTrials.gov Identifier:
    NCT03652441
    Other Study ID Numbers:
    • Uni-Koeln 3263
    • 2018-000873-59
    First Posted:
    Aug 29, 2018
    Last Update Posted:
    Nov 30, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 30, 2020