| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN26449289 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | PARMA |
| Public 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Lymphoma (non-Hodgkin's) |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom and international |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1990 |
| Anticipated end date | 30/06/1994 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN26449289 |
| Date last extracted from ISRCTN register | 17/04/2008 |
