Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LY302
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Lymphoma (Hodgkin's), Lymphoma (non-Hodgkin's)
Intervention
Patients are randomised to one of two treatment groups:
Group A: High dose therapy with ASCT, then after haematologic recovery, no further treatment.
Group B: High dose therapy with ASCT, then after haematologic recovery, interferon alpha-2b 2MU subcutaneously three times weekly for the first four weeks then 3MU three times weekly for 17 months. The interferon dose will be modified according to haematologic tolerance.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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
01/01/2000
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with histologically proven non-Hodgkin's lymphoma or Hodgkin's disease, in first relapse or first progression responding to salvage regimen, and treated with high dose therapy and ASCT
2. Normal renal and hepatic function.
3. Eastern Cooperative Oncology Group (ECOG) performance status zero to three
4. Aged 18 to 65 years
5. No history of prior or concomitant malignancy except for treated (surgery or radiotherapy) basal cell carcinoma of the skin or carcinoma in situ, whatever the site
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
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
01/01/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Industry
Funder name
Schering-Plough Ltd (UK)
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
Results - basic reporting
Publication summary