Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
12/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00003421

Protocol/serial number

LY09

Study information

Scientific title

Acronym

Study hypothesis

To perform an open-label, randomized, controlled trial comparing treatment with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) with two multidrug regimens (MDRs) for advanced Hodgkin's lymphoma (HL).

More details can be found at: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=97

Ethics approval

Not provided at time of registration

Study design

Open label randomised active controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hodgkin's lymphoma

Intervention

Patients with advanced HL (stage III to IV, or earlier stage with systemic symptoms or bulky disease) were randomly assigned between ABVD and MDR specified before randomization as alternating chlorambucil, vinblastine, procarbazine, and prednisolone (ChlVPP) with prednisolone, doxorubicin, bleomycin, vincristine, and etoposide (PABIOE), or hybrid ChlVPP/etoposide, vincristine, and doxorubicin (EVA). Radiotherapy was planned for incomplete response or initial bulk disease.

Intervention type

Drug

Phase

Not Specified

Drug names

Doxorubicin, bleomycin, vinblastine, dacarbazine, chlorambucil, vinblastine, procarbazine, prednisolone, vincristine, etoposide

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1998

Overall trial end date

01/01/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven Hodgkin's Disease requiring systemic therapy (this may also include patients with Clinical Stage IA or IIA in the presence of adverse factors, eg bulky disease or more than three sites of involvement)
2. Patient fit and able to receive chemotherapy
3. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

807

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1998

Recruitment end date

01/01/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16314615
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20498402

Publication citations

  1. Results

    Johnson PW, Radford JA, Cullen MH, Sydes MR, Walewski J, Jack AS, MacLennan KA, Stenning SP, Clawson S, Smith P, Ryder D, Hancock BW, , 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., 2005, 23, 36, 9208-9218, doi: 10.1200/JCO.2005.03.2151.

  2. Results

    Johnson PW, Sydes MR, Hancock BW, Cullen M, Radford JA, Stenning SP, Consolidation radiotherapy in patients with advanced Hodgkin's lymphoma: survival data from the UKLG LY09 randomized controlled trial (ISRCTN97144519)., J. Clin. Oncol., 2010, 28, 20, 3352-3359, doi: 10.1200/JCO.2009.26.0323.

Additional files

Editorial Notes