A randomised phase III study of intensive therapy with or without autologous bone marrow transplant (ABMT) in relapsed intermediate and high-grade non-hodgkin's lymphomas

ISRCTN	ISRCTN26449289
DOI	https://doi.org/10.1186/ISRCTN26449289
Secondary identifying numbers	PARMA

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 21/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Not Specified
Scientific title	A randomised phase III study of intensive therapy with or without autologous bone marrow transplant (ABMT) in relapsed intermediate and high-grade non-hodgkin's lymphomas
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 registration all patients receive two courses of chemotherapy with dexamethasone, cisplatin and cytarabine (DHAP). Patients who meet all the eligibility criteria and who have shown a response to initial treatment are randomised to either: 1. Regimen A: Involved field radiotherapy, 26 Gy in twenty fractions of 1.3 Gy. Radiotherapy to be given twice daily. Following radiotherapy patients receive chemotherapy carmustine, etoposide, cytarabine and cyclophosphamide (BEAC) and ABMT. 2. Regimen B: Four further courses of DHAP chemotherapy followed by involved field radiotherapy, 35 Gy in twenty fractions, to all sites of initial bulky disease.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dexamethasone, cisplatin, cytarabine
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1990
Completion date	30/06/1994

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Aged 16 to 60 years 2. Relapsed intermediate and high grade lymphoma 3. Patients must have previously been treated with an adriamycin-containing regimen or COM or COMLA 4. No central nervous system (CNS) or bone marrow involvement at relapse 5. Patients must have previously reached a first complete remission on induction regimen 6. Only first and second relapse patients are eligible
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1990
Date of final enrolment	30/06/1994

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

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

Phone	+44 (0)207 317 5186
Email	kate.law@cancer.org.uk
Website	http://www.cancer.org.uk
"ROR"	https://ror.org/054225q67

Funders

Funder type

Charity

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

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/12/1995		Yes	No

Editorial Notes

21/01/2019: Publication reference added.