A European randomised multicentre study of interferon alpha-2b versus no treatment after intensive therapy and Autologous hematopoeitic Stem Cell Transplantation (ASCT) for relapsing lymphoma patients
| ISRCTN | ISRCTN46751362 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46751362 |
| Protocol serial number | LY302 |
| Sponsor | Schering-Plough Ltd (UK) |
| Funder | Schering-Plough Ltd (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 14/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 01/01/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
