HD18 for Advanced Stages in Hodgkins Lymphoma

November 11, 2020 updated by: Prof. Dr. Andreas Engert, University of Cologne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50924
        • 1st Dept. of Medicine, Cologne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hodgkin Lymphoma (histologically proven)

  • CS (PS) IIB with one or both of the risk factors:

    • bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)
    • extranodal involvement
  • CS (PS) III, IV
  • Written informed consent

Exclusion Criteria:

  • Leucocytes < 3000/µl
  • Platelets < 100000/µl
  • Hodgkin´s lymphoma as "composite lymphoma"
  • Activity index (WHO) < grade 2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
8 cycles BEACOPPesc
Drug: BEACOPP escalated
chemotherapy with BEACOPP escalated
EXPERIMENTAL: B
8 cycles BEACOPPesc plus rituximab
Drug: BEACOPP escalated
chemotherapy with BEACOPP escalated
Drug: Rituximab
addition of Rituximab to BEACOPP escalated
ACTIVE_COMPARATOR: C
8 cycles BEACOPPesc
Drug: BEACOPP escalated
chemotherapy with BEACOPP escalated
EXPERIMENTAL: D
4 cycles BEACOPPesc
Drug: BEACOPP escalated
chemotherapy with BEACOPP escalated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 5 years
5 years
acute toxicity
Time Frame: 5 years
5 years
late toxicity
Time Frame: 5 years
5 years
CR-rate
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2008

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

July 1, 2020

Study Registration Dates

First Submitted

August 10, 2007

First Submitted That Met QC Criteria

August 10, 2007

First Posted (ESTIMATE)

August 13, 2007

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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