HD12 for Advanced Stages

Hodgkin´s Lymphoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265031
• Other study ID #: HD12
• Status: Completed
• Phase: Phase 3
• First received: December 12, 2005
• Last updated: June 22, 2012
• Start date: January 1999

Study information

• Verified date: August 2007
• 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) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• Hodgkin´s lymphoma (histologically proven)

• CS(PS) IIB with one or both of the risk factors:

1. bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)

2. extranodal involvement

• CS(PS) III, IV

• written informaed consent

Exclusion Criteria:

• Leukocytes <3000/microl

• Platelets <100000/microl

• Hodgkin´s Disease as "composite lymphoma"

• Activity index (WHO) < grade 2

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin´s Lymphoma

Intervention

Drug:
• Cyclophosphamide

• Adriamycin

• Etoposide

• Procarbazine

• Prednisone

• Vincristine

• Bleomycin

Procedure:
• radiation therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

References & Publications (1)

Borchmann P, Haverkamp H, Diehl V, Cerny T, Markova J, Ho AD, Eich HT, Mueller-Hermelink HK, Kanz L, Greil R, Rank A, Paulus U, Smardova L, Huber C, Dörken B, Nerl C, Krause SW, Mueller RP, Fuchs M, Engert A. Eight cycles of escalated-dose BEACOPP compare — View Citation

External Links

•   Description of study i German (Website of the Competence Network Malignant Lymphoma)