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

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
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dexamethasone, cisplatin, cytarabine
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/1994

Participant type(s)	Patient
Age group	Adult
Sex
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

UKCCCR Register Co-ordinator

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	07/12/1995		Yes	No

21/01/2019: Publication reference added.