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

Primary Purpose

Classical Hodgkin Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Brentuximab Vedotin
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Classical Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 1st Department of Medicine, Cologne University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Maintenance

Arm Description

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

Outcomes

Primary Outcome Measures

1-year Cumulative incidence of relapse (CIR)
1-year Cumulative incidence of relapse (CIR)

Secondary Outcome Measures

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

Full Information

First Posted
August 28, 2018
Last Updated
November 26, 2020
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT03652441
Brief Title
Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma
Official Title
Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Classical Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maintenance
Arm Type
Experimental
Arm Description
Brentuximab Vedotin will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions
Intervention Type
Drug
Intervention Name(s)
Brentuximab Vedotin
Other Intervention Name(s)
BV
Intervention Description
BV will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions
Primary Outcome Measure Information:
Title
1-year Cumulative incidence of relapse (CIR)
Description
1-year Cumulative incidence of relapse (CIR)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
1- and 2-year Progression-free survival (PFS)
Description
1- and 2-year Progression-free survival (PFS)
Time Frame
1 and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Fuchs
Phone
+49221478
Ext
88200
Email
ghsg@uk-koeln.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christof Scheid, Prof.
Organizational Affiliation
University of Cologne, I. Dept. of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Department of Medicine, Cologne University Hospital
City
Cologne
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christof Scheid, Prof.
Email
GHSG@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Christof Scheid, MD
First Name & Middle Initial & Last Name & Degree
Andreas Engert, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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