Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma
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 Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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Outcome Measures
Primary Outcome Measures
- 1-year Cumulative incidence of relapse (CIR) [1 year]
1-year Cumulative incidence of relapse (CIR)
Secondary Outcome Measures
- 1- and 2-year Progression-free survival (PFS) [1 and 2 years]
1- and 2-year Progression-free survival (PFS)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with relapsed/refractory cHL who receive an allogeneic stem cell transplantation
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Histologically proven cHL in the most recent tumor biopsy
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Absolute neutrophil count ≥ 500/mm³
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ECOG ≤2
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Age ≥ 18 years
Exclusion Criteria:
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Presence of nodular lymphocyte-predominant HL (NLPHL) or grey-zone lymphoma
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Progressive disease as last documented response prior to alloSCT
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Any peripheral neuropathy ≥ grade 2
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Any other serious disease or organ dysfunction which might impair protocol treatment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | 1st Department of Medicine, Cologne University Hospital | Cologne | Germany |
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.- Uni-Koeln 3263
- 2018-000873-59