HD16 for Early Stage Hodgkin Lymphoma

Phase 3

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine); Radiation: 20 Gy IFRT (Involved Field Radiotherapy)

• Registration Number: NCT00736320
• Lead Sponsor: University of Cologne

Brief Summary

This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-08
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Study Start: 2009-11
• Primary Completion: 2018-09
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1150

Inclusion Criteria

• Hodgkin Lymphoma

• CS I, II without risk factors

  • large mediastinal mass (> 1/3 of maximum transverse thorax diameter)
  • extranodal involvement
  • elevated ESR
  • 3 or more involved nodal areas

• Written informed consent

Exclusion Criteria

• Leucocytes < 3000/µl
• Platelets < 100000/µl
• Hodgkin Lymphoma as composite lymphoma
• Activity index (WHO) > 2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)	2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy
A	20 Gy IFRT (Involved Field Radiotherapy)	2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy
B	ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)	2 cycles ABVD followed by 20 Gy IF-RT if FDG-PET is positive after chemotherapy; 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
B	20 Gy IFRT (Involved Field Radiotherapy)	2 cycles ABVD followed by 20 Gy IF-RT if FDG-PET is positive after chemotherapy; 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	5 years

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years
acute toxicity	5 years
late toxicity	5 years
CR rate	5 years

Trial Locations

Locations (1)

1st Dept. of Medicine, Cologne University Hospital; 🇩🇪 Cologne, Germany