Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SNLG NHLV(A)
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lymphoma (non-Hodgkin's)
Intervention
All patients receive induction chemotherapy with CHOP or VAPEC-B. Patients in complete or good partial remission following induction receive radiotherapy to the areas of bulky disease.
Patients are then randomised as follows:
GOOD RISK PATIENTS: Good risk patients are randomised to one of two treatment arms:
1. Arm A: No treatment
2. Arm B: High dose melphan and autologous bone marrow transplant (ABMT)
INTERMEDIATE/POOR PATIENTS: Patients are randomised to one of two treatment arms:
3. Arm C: High dose melphan and ABMT
4. Arm D: Patients receive high dose melphan, total body irradiation 10.5 Gy in three fractions over 24 h plus ABMT or a BEAM chemotherapy transplant
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
01/01/1995
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with high grade non-Hodgkin's lymphoma
2. Stage I-IV disease, stage I and II patients must require chemotherapy
3. Aged 15 to 65 years
4. Adequate marrow, hepatic and renal function
5. Patients with localised gut lymphoma, Burkitt's lymphoma and lymphoblastic T-cell with large mediastinal mass are excluded
6. No central nervous system (CNS) involvement
7. No previous malignant disease except skin or cervical carcinoma stage I
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
01/01/1995
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Research organisation
Funder name
Scotland & Newcastle Lymphoma Group (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