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Phase I/II Feasibility Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (DHAP) in Hodgkin Lymphoma Patients

NCT02280993 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-03-13

No results posted yet for this study

Summary

To combine Brentuximab Vedotin with Dexamethasone, AraC and Cisplatin (DHAP) chemotherapy in patients with Hodgkin lymphoma (HL) refractory to first line chemotherapy or in first relapse is expected to induce a significantly higher (metabolic) complete remission (CR) rate prior to consolidation with BEAM, as judged by FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose)-PET negativity. This will be compared with published data on DHAP salvage only. Increasing the metabolic CR rate prior to consolidation with high dose chemotherapy and autologous stem cell transplantation (ASCT) is expected to improve progression free survival (PFS) and overall survival (OS).

Conditions

Interventions

DRUG

DHAP

DHAP

DRUG

Brentuximab Vedotin

Brentuximab Vedotin

OTHER

Autologous Peripheral Blood Stem Cell Transplantation

Autologous Peripheral Blood Stem Cell Transplantation

Sponsors & Collaborators

  • Millennium: The Takeda Oncology Company

    collaborator INDUSTRY

  • Marjolein Spiering

    lead OTHER

Principal Investigators

  • Anton Hagenbeek, PhD MD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • Marie José Kersten, PhD MD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • Marjolein Spiering, MSc · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2018-11-30
Completion
2020-05-31

Countries

  • Denmark
  • France
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02280993 on ClinicalTrials.gov