A comparison of hybrid chemotherapy versus hybrid chemotherapy and autotransplant in poor prognosis Hodgkin's disease

ISRCTN	ISRCTN39498786
DOI	https://doi.org/10.1186/ISRCTN39498786
Protocol serial number	SNLG HDIII
Sponsor	UK Co-ordinating Committee for Cancer Research (UKCCCR)
Funder	Not provided at time of registration

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
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
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 (Hodgkin's)
Intervention	All patients receive three 28-day cycles of PVACE-BOP (chlorambucil, procarbazine, etoposide, vinblastine, adriamycin, bleomycin and prednisolone), together with co-trimoxazole every 3 weeks for the duration of treatment. Patients who achieve at least a partial remission are randomised to one of two treatment regimens: 1. Regimen A: Radiotherapy, 30 Gy in 3 weeks to initially bulky sites or residual areas of disease, followed by two further cycles of PVACE-BOP 2. Regimen B: Radiotherapy, 30 Gy in 3 weeks to initially bulky sites or residual areas of disease, followed by intensive chemotherapy with melphan and etoposide plus autologous bone marrow transplantation.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Adult
Sex	All
Key inclusion criteria	1. Histological diagnosis of Hodgkin's disease 2. Prognostic index of at least 0.5 3. Aged under 60 4. No prior chemotherapy or radiotherapy 5. No known significant heart, lung or renal disease 6. No co-existing malignancies apart from localised skin lesions
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2001
Date of final enrolment	31/12/2004

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2002		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes