A randomised trial to evaluate early high dose therapy and autologous bone marrow transplantation as part of planned initial therapy for poor risk intermediate/high grade non-Hodgkin's lymphoma
| ISRCTN | ISRCTN97344827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97344827 |
| ClinicalTrials.gov number | NCT00003578 |
| Secondary identifying numbers | LY02 |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 25/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David Linch
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) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised trial to evaluate early high dose therapy and autologous bone marrow transplantation as part of planned initial therapy for poor risk intermediate/high grade non-Hodgkin's lymphoma |
| 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 (non-Hodgkin's) |
| Intervention | Following randomisation patients receive standard chemotherapy with cyclophosphamide, hydroxydaunorubicin, vincristine and prednisone (CHOP) to be repeated every 21 days for three courses. Patients who show partial or complete response following initial chemotherapy are treated according to the initial randomisation: 1. Regimen A: Continue standard chemotherapy with (CHOP) to be given for two courses beyond complete remission with a minimum of six courses or until progression. 2. Regimen B: High dose therapy with BCNU, etoposide, cytosine-arabinoside and melphan plus ABMT. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cyclophosphamide, hydroxydaunorubicin, vincristine, prednisone, etoposide, cytosine-arabinoside, melphan |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1996 |
| Completion date | 31/10/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Age 16-65 years 2. No medical conditions other than lymphoma, prohibiting intensive therapy. No systemic treatment for cancer in the previous 5 years 3. Histology: Follicular large cell lymphoma; Diffuse mixed cell lymphoma; Diffuse large cell lymphoma; Diffuse immunoblastic lymphoma 4. Full clinical staging to include Computed Tomography (CT) scanning of abdomen and bone marrow trephine biopsy 5. Poor prognostic features, defined as the presence of two or three of: Stage III or IV; Lactic dehydrogenase (LDH) > normal; Performance status 2-4 (Eastern Cooperative Oncology Group [ECOG]-World Health Organisation [WHO]) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1996 |
| Date of final enrolment | 31/10/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
| Phone | +44 (0)207 317 5186 |
|---|---|
| kate.law@cancer.org.uk | |
| Website | http://www.cancer.org.uk |
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2010 | 25/01/2019 | Yes | No |
Editorial Notes
25/01/2019: PUblication reference added
