Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
24/02/2015
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

- - -

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

NCT00003578

Protocol/serial number

LY02

Study information

Scientific title

A randomised trial to evaluate early high dose therapy and autologous bone marrow transplantation as part of planned initial therapy for poor risk intermediate/high grade non-Hodgkin's lymphoma

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

Hospitals

Trial type

Treatment

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

Following randomisation patients receive standard chemotherapy with cyclophosphamide, hydroxydaunorubicin, vincristine and prednisone (CHOP) to be repeated every 21 days for three courses. Patients who show partial or complete response following initial chemotherapy are treated according to the initial randomisation:

1. Regimen A: Continue standard chemotherapy with (CHOP) to be given for two courses beyond complete remission with a minimum of six courses or until progression.

2. Regimen B: High dose therapy with BCNU, etoposide, cytosine-arabinoside and melphan plus ABMT.

Intervention type

Drug

Phase

Not Applicable

Drug names

Cyclophosphamide, hydroxydaunorubicin, vincristine, prednisone, etoposide, cytosine-arabinoside, melphan

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1996

Overall trial end date

31/10/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 16-65 years
2. No medical conditions other than lymphoma, prohibiting intensive therapy. No systemic treatment for cancer in the previous 5 years
3. Histology: Follicular large cell lymphoma; Diffuse mixed cell lymphoma; Diffuse large cell lymphoma; Diffuse immunoblastic lymphoma
4. Full clinical staging to include Computed Tomography (CT) scanning of abdomen and bone marrow trephine biopsy
5. Poor prognostic features, defined as the presence of two or three of: Stage III or IV; Lactic dehydrogenase (LDH) > normal; Performance status 2-4 (Eastern Cooperative Oncology Group [ECOG]-World Health Organisation [WHO])

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1996

Recruitment end date

31/10/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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