Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003578
Protocol/serial number
LY02
Study information
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
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
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Cyclophosphamide, hydroxydaunorubicin, vincristine, prednisone, etoposide, cytosine-arabinoside, melphan
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1996
Overall trial end date
31/10/2001
Reason abandoned
Eligibility
Participant 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])
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1996
Recruitment end date
31/10/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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