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

University of Cologne

Status and phase: Completed; Phase 2

Conditions: Hodgkin´s Lymphoma

Treatments: Drug: Bleomycin; Drug: Prednisone; Drug: Adramycin; Drug: Erythropoietin beta; Drug: Procarbacine; Drug: Vincristine; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00284271

BACOPP-21

Details and patient eligibility

About

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

Enrollment: 65 patients

Sex: All

Ages: 61 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)