Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
PARMA
Study information
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
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Not Specified
Patient information sheet
Condition
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
Overall study end date
30/06/1994
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1990
Recruitment end date
30/06/1994
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
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
ROR
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/12/1995 | Yes | No |