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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 27, 2006

Last Updated Date

August 7, 2007

Start Date ^†

November 2003

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00284271 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Hodgkin´s Lymphoma

Intervention ^†

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

61 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00284271

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University of Cologne

Collaborators ^††

Investigators ^†

Principal Investigator:

Andreas Josting, Dr.

University of Cologne

Information Provided By

University of Cologne

Verification Date

August 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.