Consolidation Therapy With Brentuximab Vedotin After Allo... | NCT03652441

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

NCT03652441

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Mar 5, 2026Actual

Enrollment

14Actual

Phase

Phase 2

Conditions

Classical Hodgkin Lymphoma

Interventions

Brentuximab Vedotin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018-000873-59	EudraCT Number

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 13, 2019Actual

Primary Completion Date

Aug 10, 2023Actual

Completion Date

Jan 25, 2025Actual

First Submitted Date

Aug 28, 2018

First Submission Date that Met QC Criteria

Aug 28, 2018

First Posted Date

Aug 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2026

Last Update Posted Date

Mar 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Maintenance	Experimental	Brentuximab Vedotin will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions	Drug: Brentuximab Vedotin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brentuximab Vedotin	Drug	BV will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions	Maintenance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1-year Cumulative incidence of relapse (CIR)	1-year Cumulative incidence of relapse (CIR)	1 year

Secondary Outcomes

Measure	Description	Time Frame
1- and 2-year Progression-free survival (PFS)	1- and 2-year Progression-free survival (PFS)	1 and 2 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christof Scheid, Prof.	University of Cologne, I. Dept. of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1st Department of Medicine, Cologne University Hospital		Cologne			Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000079963	Brentuximab Vedotin

Ancestor Terms

ID	Term
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized

Browse Leaves

Not provided

Browse Branches

Not provided