HD18 for Advanced Stages in Hodgkins Lymphoma

Sponsor
University of Cologne
Study ID
NCT00515554
Phase
PHASE3
Status
Completed

Conditions

  • Hodgkins Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    addition of Rituximab to BEACOPP escalated
  • BEACOPP escalated — DRUG
    chemotherapy with BEACOPP escalated

Study Details

This study is designed to test: 1. in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles) 2. for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS.

Key Dates

Start date
May 31, 2008
Status verified
Nov 2020
Primary completion
Jul 31, 2019
Completion
Jul 31, 2020

Study Design

Enrollment
1,500 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A
    8 cycles BEACOPPesc
  • Experimental: B
    8 cycles BEACOPPesc plus rituximab
  • Active Comparator: C
    8 cycles BEACOPPesc
  • Experimental: D
    4 cycles BEACOPPesc

Primary Outcome Measure

Progression Free Survival [ Time Frame: 5 years ]

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