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 |
| Secondary identifying numbers | LY302 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1999 |
| Completion date | 01/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Schering-Plough Ltd (UK)
Industry
Industry
Schering-Plough House
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
"ROR" |
https://ror.org/00148fb49 |
|---|
Funders
Funder type
Industry
Schering-Plough Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
