Feasibility and Efficacy of BACOPP-21 for Patients > 60 Years With Intermediate or Advanced Hodgkins Lymphoma

Phase 2

Completed

• Conditions: Hodgkin´s Lymphoma

• Registration Number: NCT00284271
• Lead Sponsor: University of Cologne

Brief Summary

This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2) toxicity, overall response and FFTF.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-12
• Study First Submitted: 2006-01-27
• Study First Submitted QC: 2006-01-27
• Study First Posted: 2006-01-31
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-28
• Last Update Posted: 2011-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Hodgkin´s lymphoma (histologically proven)

• CS (PS) I and II with one of the risk factors a-d

  1. bulky mediastinal mass (> 1/3 maximum transverse thorax diameter)
  2. extranodal involvement
  3. ESR > 50 (A), > 30 (B-symptoms)
  4. 3 or more lymph node areas involved

• CS (PS) III and IV

• Written informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

University of Cologne; 🇩🇪 Cologne, Germany