HD10 for Early Stages

Hodgkin´s Lymphoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265018
• Other study ID #: HD10
• Status: Completed
• Phase: Phase 3
• First received: December 12, 2005
• Last updated: July 28, 2011
• Start date: May 1998

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 find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1370
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• Hodgkin´s lymphoma (histologically proven)

• CS (PS) IA, IB, IIA,IIB without any of the following risk factors:

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

• 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:
• Adriamycin

• Bleomycin

• Vinblastine

• DTIC

Radiation:
• 30 Gy IF-RT

• 20 Gy IF-RT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

References & Publications (1)

Engert A, Plütschow A, Eich HT, Lohri A, Dörken B, Borchmann P, Berger B, Greil R, Willborn KC, Wilhelm M, Debus J, Eble MJ, Sökler M, Ho A, Rank A, Ganser A, Trümper L, Bokemeyer C, Kirchner H, Schubert J, Král Z, Fuchs M, Müller-Hermelink HK, Müller RP, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)		5 years	No

External Links

•   Description of study in Gereman (Website of the Competence Network Malignant Lymphoma