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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof David Linch
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
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)
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 / device / biological / vaccine name(s)	Cyclophosphamide, hydroxydaunorubicin, vincristine, prednisone, etoposide, cytosine-arabinoside, melphan
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/10/2001

Participant type(s)	Patient
Age group	Adult
Sex	All
Key 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])
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1996
Date of final enrolment	31/10/2001

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010	25/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

25/01/2019: PUblication reference added