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

Hodgkin´s Lymphoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284271
• Other study ID #: BACOPP-21
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2006
• Last updated: July 28, 2011
• Start date: January 2004

Study information

• Verified date: July 2011
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 61 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin´s Lymphoma

Intervention

Drug:
• Cyclophosphamide

• Adramycin

• Procarbacine

• Prednisone

• Vincristine

• Bleomycin

• Erythropoietin beta

Locations

Country	Name	City	State
Germany	University of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Halbsguth TV, Nogová L, Mueller H, Sieniawski M, Eichenauer DA, Schober T, Nisters-Backes H, Borchmann P, Diehl V, Engert A, Josting A. Phase 2 study of BACOPP (bleomycin, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone) in older p — View Citation