Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma
NCT ID: NCT03652441
Last Updated: 2020-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
21 participants
INTERVENTIONAL
2019-11-13
2023-08-31
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Maintenance
Brentuximab Vedotin will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions
Brentuximab Vedotin
BV will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions
Interventions
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Brentuximab Vedotin
BV will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically proven cHL in the most recent tumor biopsy
* Absolute neutrophil count ≥ 500/mm³
* ECOG ≤2
* Age ≥ 18 years
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Cologne
OTHER
Responsible Party
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Christoph Scheid
Head of Stem Cell Transplantation
Principal Investigators
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Christof Scheid, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Cologne, I. Dept. of Medicine
Locations
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1st Department of Medicine, Cologne University Hospital
Cologne, , Germany
Countries
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Central Contacts
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Facility Contacts
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Christof Scheid, Prof.
Role: primary
Other Identifiers
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2018-000873-59
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Uni-Koeln 3263
Identifier Type: -
Identifier Source: org_study_id