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

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ClinicalTrials.gov Identifier: NCT03652441
Recruitment Status : Not yet recruiting
First Posted : August 29, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Christoph Scheid, University of Cologne

Tracking Information
First Submitted Date  ICMJE August 28, 2018
First Posted Date  ICMJE August 29, 2018
Last Update Posted Date September 5, 2018
Estimated Study Start Date  ICMJE October 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
1-year Cumulative incidence of relapse (CIR) [ Time Frame: 1 year ]
1-year Cumulative incidence of relapse (CIR)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03652441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
1- and 2-year Progression-free survival (PFS) [ Time Frame: 1 and 2 years ]
1- and 2-year Progression-free survival (PFS)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma
Official Title  ICMJE Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Classical Hodgkin Lymphoma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Maintenance
Brentuximab Vedotin will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions
Intervention: Drug: Brentuximab Vedotin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2018)
21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Fuchs +49221478 ext 88200 ghsg@uk-koeln.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03652441
Other Study ID Numbers  ICMJE Uni-Koeln 3263
2018-000873-59 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Christoph Scheid, University of Cologne
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christof Scheid, Prof. University of Cologne, I. Dept. of Medicine
PRS Account University of Cologne
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP