|
ISRCTN
|
ISRCTN58831878
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A randomised trial of high dose therapy and autologous bone marrow transplantation versus continuing conventional combination chemotherapy for adults with lymphoblastic lymphoma
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
LY01
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Lymphoma (non-Hodgkins) cancer
|
|
Participants - inclusion criteria
|
1. Histologically documented lymphoblastic lymphoma
2. No prior chemotherapy or radiotherapy, except chemotherapy given for immediate relief of symptoms at presentation
3. Age 15 or over
4. All stages
5. No circulating blasts
6. Normal values for renal and hepatic function, unless directly attributable to lymphoma
7. Normal cardiac function
8. No evidence of Human Immunodeficiency Virus (HIV) infection
|
|
Participants - exclusion criteria
|
Patients will be excluded if they have HLA-identical siblings who are undergoing allogenic bone marrow transplantation. These patients should be registered with the trials office but will not be randomised.
|
|
Anticipated start date
|
01/01/1992
|
|
Anticipated end date
|
30/04/1997
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
All patients receive induction therapy and conventional chemotherapy regimens.
Patients achieving complete remission or partial remission are randomised to either:
1. Regimen A: Continue therapy on conventional regimen. The recommended conventional regimen is modified LSA2L2.
2. Regimen B: High dose therapy and ABMT.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Cancer Research UK
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
Cancer Research UK (CRUK) (UK)
|
|
Address
|
PO Box 123
Lincoln's Inn Fields
|
|
City/town
|
London
|
|
Zip/Postcode
|
WC2A 3PX
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7317 5186
|
|
Fax
|
+44 (0)20 7487 4302
|
|
Email
|
kate.law@cancer.org.uk
|
|
Sponsor website:
|
http://www.cancer.org.uk
|
|
Date applied
|
01/07/2001
|
|
Last edited
|
27/05/2008
|
|
Date ISRCTN assigned
|
01/07/2001
|