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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652441
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Christoph Scheid, University of Cologne

Study Description
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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 disease Intervention/treatment Phase
Classical Hodgkin Lymphoma Drug: Brentuximab Vedotin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 13, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/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 Name: BV


Outcome Measures
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Primary Outcome Measures :
  1. 1-year Cumulative incidence of relapse (CIR) [ Time Frame: 1 year ]
    1-year Cumulative incidence of relapse (CIR)


Secondary Outcome Measures :
  1. 1- and 2-year Progression-free survival (PFS) [ Time Frame: 1 and 2 years ]
    1- and 2-year Progression-free survival (PFS)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652441


Contacts
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Contact: Michael Fuchs +49221478 ext 88200 ghsg@uk-koeln.de

Locations
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Germany
1st Department of Medicine, Cologne University Hospital Recruiting
Cologne, Germany
Contact: Christof Scheid, Prof.       GHSG@uk-koeln.de   
Principal Investigator: Christof Scheid, MD         
Sub-Investigator: Andreas Engert, MD         
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Christof Scheid, Prof. University of Cologne, I. Dept. of Medicine
More Information
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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 ( EudraCT Number )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Brentuximab Vedotin
Antineoplastic Agents, Immunological
Antineoplastic Agents