Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Not specified		MRC-UKLG-LY09 EU-98020, NCT00003421

Objectives

I.  Determine whether a four-drug anthracycline-based regimen or a seven-drug 
hybrid or eight-drug alternating regimen is the optimal treatment for patients 
with advanced Hodgkin's disease.

Entry Criteria

Disease Characteristics:

Histologically confirmed advanced Hodgkin's disease requiring systemic therapy
 Stage IA or IIA disease with bulky disease or more than three sites of
 involvement are also eligible 

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified   

Chemotherapy:
 No prior chemotherapy for Hodgkin's disease

Endocrine therapy:
 Not specified   

Radiotherapy:
 No prior radiotherapy for Hodgkin's disease

Surgery:
 Not specified   

Patient Characteristics:

Age:
 Not specified   

Performance status:
 Not specified   

Hematopoietic:
 Not specified   

Hepatic:
 Not specified   

Renal:
 Not specified   

Other:
 No other active malignancy within 5 years
 HIV negative
 Not pregnant or nursing
 Fertile patients must use effective contraception

Expected Enrollment

Approximately 800 patients will be accrued for this study.

Outline

This is a randomized study.  Patients are randomized to one of two treatment 
arms.

Arm I (ABVD): Patients receive doxorubicin IV, bleomycin IV, vinblastine IV, 
and dacarbazine IV on days 1 and 15.  Courses repeat every 4 weeks.

Arm II (ChlVPP/PABLOE):  Patients receive oral chlorambucil, procarbazine, and 
prednisolone on days 1-14; vinblastine IV on days 1 and 8; doxorubicin IV on 
day 29; vincristine IV and bleomycin IV on days 29 and 36; oral etoposide on 
days 29-31; and oral prednisolone again on days 29-38.  Courses repeat every 7 
weeks.
OR
(Hybrid - ChlVPP/EVA):  Patients receive vincristine IV on day 1; oral 
etoposide on days 1-5; oral chlorambucil, procarbazine, and prednisolone on 
days 1-7; and doxorubicin IV and vinblastine IV on day 8.  Courses repeat 
every 4 weeks.

Patients in both arms receive up to 6-8 courses of treatment.

Radiotherapy may be given to sites of previous bulk disease for patients in 
complete remission or uncertain remission.  Patients who achieve partial 
remission may receive radiotherapy to residual disease sites.  Patients who 
fail to respond, or have disease progression, may receive induction therapy 
followed by high-dose consolidation therapy.

Patients are followed every 3 months for 2 years, every 6 months for 5 years, 
and then annually for 5 years.

Johnson PW, Radford JA, Cullen MH, et al.: Comparison of ABVD and alternating or hybrid multidrug regimens for the treatment of advanced Hodgkin's lymphoma: results of the United Kingdom Lymphoma Group LY09 Trial (ISRCTN97144519). J Clin Oncol 23 (36): 9208-18, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Barry Hancock, MD, Protocol chair		Ph: 44-114-226-5000 ext. 5007 Email: b.w.hancock@sheffield.ac.uk

Registry Information
Official Title		A UKLG Randomised Trial of Initial Chemotherapy for Advanced Stage Hodgkins Disease
Trial Start Date		1998-06-05
Registered in ClinicalTrials.gov		NCT00003421
Date Submitted to PDQ		1998-07-09
Information Last Verified		2007-05-21