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ISRCTN
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ISRCTN26449289
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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PARMA
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom, International
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Disease/condition/study domain
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Lymphoma (non-Hodgkin's)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1990
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Anticipated end date
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30/06/1994
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK (CRUK) (UK)
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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19/08/2002
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Last edited
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14/08/2008
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Date ISRCTN assigned
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19/08/2002
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