A randomised trial of high dose therapy and autologous bone marrow transplantation versus continuing conventional combination chemotherapy for adults with lymphoblastic lymphoma

ISRCTN	ISRCTN58831878
DOI	https://doi.org/10.1186/ISRCTN58831878
Secondary identifying numbers	LY01

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

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 of high dose therapy and autologous bone marrow transplantation versus continuing conventional combination chemotherapy for adults with lymphoblastic 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) cancer
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1992
Completion date	30/04/1997

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
Total final enrolment	119
Key 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
Key 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.
Date of first enrolment	01/01/1992
Date of final enrolment	30/04/1997

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2001	28/11/2019	Yes	No

28/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.