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

Primary Purpose

Hodgkin´s Lymphoma

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Cyclophosphamide

Adramycin

Procarbacine

Prednisone

Vincristine

Bleomycin

Erythropoietin beta

About this trial

This is an interventional treatment trial for Hodgkin´s Lymphoma focused on measuring Hodgkin´s Lymphoma, eldery patients, primary diagnosis

Eligibility Criteria

61 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hodgkin´s lymphoma (histologically proven) CS (PS) I and II with one of the risk factors a-d bulky mediastinal mass (> 1/3 maximum transverse thorax diameter) extranodal involvement ESR > 50 (A), > 30 (B-symptoms) 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

Sites / Locations

University of Cologne

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00284271

First Posted

January 27, 2006

Last Updated

July 28, 2011

Sponsor

University of Cologne

1. Study Identification

Unique Protocol Identification Number

NCT00284271

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

December 2005 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Cologne

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin´s Lymphoma

Keywords

Hodgkin´s Lymphoma, eldery patients, primary diagnosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

Adramycin

Intervention Type

Drug

Intervention Name(s)

Procarbacine

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Type

Drug

Intervention Name(s)

Vincristine

Intervention Type

Drug

Intervention Name(s)

Bleomycin

Intervention Type

Drug

Intervention Name(s)

Erythropoietin beta

10. Eligibility

Sex

All

Minimum Age & Unit of Time

61 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Josting, Dr.

Organizational Affiliation

University of Cologne

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cologne

City

Cologne

ZIP/Postal Code

50931

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

20551376

Citation

Halbsguth TV, Nogova 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 patients with Hodgkin lymphoma: a report from the German Hodgkin Study Group (GHSG). Blood. 2010 Sep 23;116(12):2026-32. doi: 10.1182/blood-2009-11-253211. Epub 2010 Jun 15.

Results Reference

result

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

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