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OpenTrials
Completed

NCT Number: NCT00515554

HD18 for Advanced Stages in Hodgkins Lymphoma

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.

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Key information

Conditions

Hodgkins Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1st Dept. of Medicine, Cologne University Hospital

Cologne, 50924, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

addition of Rituximab to BEACOPP escalated

BEACOPP escalated

Drug

chemotherapy with BEACOPP escalated

Primary outcomes

  1. Progression Free Survival

    Time frame: 5 years

Secondary outcomes

  1. Overall Survival

    Time frame: 5 years

  2. acute toxicity

    Time frame: 5 years

  3. late toxicity

    Time frame: 5 years

  4. CR-rate

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Important dates

Study start
2008
Primary completion
2019
Study completion
2020
First posted
Aug 13, 2007
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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