Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

Sponsor information

Organisation

Schering-Plough Ltd (UK)

Sponsor details

Schering-Plough House
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes