Phase III Randomized Study of a Four-Drug Anthracycline-Based Regimen or a Seven-Drug Hybrid or Eight-Drug Alternating Regimen in Patients With Advanced Hodgkin's Disease. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. cannot verify the accuracy of the information.

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Alternate Title

Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedNot specifiedMRC-UKLG-LY09
EU-98020, NCT00003421


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   

 No prior chemotherapy for Hodgkin's disease

Endocrine therapy:
 Not specified   

 No prior radiotherapy for Hodgkin's disease

 Not specified   

Patient Characteristics:

 Not specified   

Performance status:
 Not specified   

 Not specified   

 Not specified   

 Not specified   

 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.


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

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 
(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.

Published Results

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

Registry Information

Official TitleA UKLG Randomised Trial of Initial Chemotherapy for Advanced Stage Hodgkins Disease
Trial Start Date1998-06-05
Registered in ClinicalTrials.govNCT00003421
Date Submitted to PDQ1998-07-09
Information Last Verified2007-05-21

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.