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

This study has been completed.

Sponsored by:	University of Cologne
Information provided by:	University of Cologne
ClinicalTrials.gov Identifier:	NCT00284271

Purpose

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

Condition	Intervention	Phase
Hodgkin´s Lymphoma	Drug: Cyclophosphamide Drug: Adramycin Drug: Procarbacine Drug: Prednisone Drug: Vincristine Drug: Bleomycin Drug: Erythropoietin beta	Phase II

MedlinePlus related topics: Hodgkin's Disease Lymphoma

Drug Information available for: Cyclophosphamide Prednisone Vincristine sulfate Vincristine Epoetin alfa Erythropoietin Bleomycin Bleomycin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by University of Cologne:

Estimated Enrollment:	60
Study Start Date:	November 2003

Eligibility

Ages Eligible for Study:	61 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284271

Locations

Germany
University of Cologne
Cologne, Germany, 50931

Sponsors and Collaborators

University of Cologne

Investigators

Principal Investigator:

Andreas Josting, Dr.

University of Cologne

More Information

Study ID Numbers:	BACOPP-21
Study First Received:	January 27, 2006
Last Updated:	August 7, 2007
ClinicalTrials.gov Identifier:	NCT00284271
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:

Hodgkin´s Lymphoma
eldery patients
primary diagnosis

Study placed in the following topic categories:

Epoetin Alfa
Prednisone
Lymphatic Diseases
Hodgkin's disease
Immunoproliferative Disorders
Hodgkin lymphoma, adult

Vincristine
Cyclophosphamide
Lymphoproliferative Disorders
Bleomycin
Hodgkin Disease
Lymphoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antimitotic Agents
Hormones

Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009