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ISRCTN
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ISRCTN42558989
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ClinicalTrials.gov identifier
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Public title
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A Randomised Study of High-Dose Chemotherapy/ Radiotherapy and Autologous Bone Marrow Transplantation in Patients with High Grade Non-Hodgkin's Lymphoma in First Complete Remission
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Scientific title
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Acronym
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N/A
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Serial number at source
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SNLG NHLV(A)
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Lymphoma (non-Hodgkin's)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1995
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Anticipated end date
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31/12/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Scotland & Newcastle Lymphoma Group (UK)
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Scotland & Newcastle Lymphoma Group (UK)
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Address
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Medical Statistics Unit, Department of Public Health Sciences
University of Edinburgh
Medical School
Teviot Place
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City/town
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Edinburgh
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Zip/Postcode
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EH8 9AG
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Country
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United Kingdom
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Date applied
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19/08/2002
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Last edited
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28/04/2008
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Date ISRCTN assigned
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19/08/2002
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