Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BNLI2
Study information
Scientific title
Randomised trial in newly diagnosed Hodgkin's disease: evaluation of drug scheduling (alternating LOPP/EVAP versus LOPP/EVA hybrid) and consolidation radiotherapy
Acronym
Study hypothesis
Evaluation of drug scheduling (alternating LOPP/EVAP versus LOPP/EVA hybrid) and consolidation radiotherapy
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
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
1. Regimen A: Chemotherapy, chlorambucil vincristine, procarbazine and prednisolone (LOPP) alternating every 28 days with etoposide, vinblastine, adriamycin and prednisolone (EVAP). A course of chemotherapy is given every 28 days for a minimum of six cycles.
2. Regimen B: Chemotherapy, chlorambucil, vincristine, procarbazine and prednisolone, etoposide, vinblastine, adriamycin (LOPP/EVA) repeated every 28 days for a minimum of six cycles.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1999
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged over 15 years
2. Stage IB, IIB, III or IV Hodgkin's Disease.
3. Histologically confirmed Hodgkin's lymphoma
4. Free from any potentially life threatening disease other than Hodgkin's Disease
5. Lymphangiography or Computed Tomography (CT) scan of the abdomen
6. No previous treatment except as an emergency measure
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1999
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
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
Funders
Funder type
Charity
Funder name
Lymphoma Research Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Funder name
Lisa Lear Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Isle of Man Anti-Cancer Association
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list