Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
08/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Scotland & Newcastle Lymphoma Group (UK)

Sponsor details

Medical Statistics Unit
Department of Public Health Sciences
University of Edinburgh
Medical School
Teviot Place
Edinburgh
EH8 9AG
United Kingdom

Sponsor type

Research organisation

Website

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

Publication citations

Additional files

Editorial Notes