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ISRCTN
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ISRCTN77346223
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DOI
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10.1186/ISRCTN77346223
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ClinicalTrials.gov identifier
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NCT00002514
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EudraCT number
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2005-006181-31
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Public title
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Acute lymphoblastic leukaemia (ALL) trial XII (joint trial with Eastern Co-operative Oncology Group - E2993)
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Scientific title
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Acronym
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UKALLXII
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Serial number at source
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G8223452, MREC/02/2/84
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Study hypothesis
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1. To compare effects of marrow ablative therapy using VP16 and total body irradiation followed by autologous bone marrow rescue (ABMT or Peripheral Stem Cell Rescue) with conventional consolidation and maintenance chemotherapy in adult patients between 15 and 55 years who have no HLA compatible donor
2. To examine (in a non-randomised study) differences in outcome in adult ALL in those patients who have an HLA compatible donor, who will be allocated allogeneic BMT versus those with a donor randomised to autologous BMT or conventional chemotherapy
3. To compare the outcome of the above three treatments or matched unrelated donor BMT in patients with Philadelphia chromosome positive disease and to examine the efficacy of additional Interferon during maintenance chemotherapy or after BMT
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Lay summary
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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
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Disease/condition/study domain
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Leukaemia
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Participants - inclusion criteria
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1. Adult patients between 15 and 55 years with previously untreated ALL
2. Morphological proof of ALL
3. Diagnosis has been made from bone marrow morphology with greater than 25% lymphoblasts by the French-American-British (FAB) criteria
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Participants - exclusion criteria
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1. Prior malignancy for which chemotherapy or radiotherapy have been given
2. AML, MDS or other antecedent haematological disorder or lymphoid transformation of chronic myeloid leukaemia
3. Previously treated
4. Intercurrent life threatening disease
5. Pregnant or lactating
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Anticipated start date
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01/01/1993
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Anticipated end date
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30/09/2008
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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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550
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Interventions
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1. Marrow ablative therapy using VP16 and total body irradiation followed by autologous bone marrow rescue (ABMT or Peripheral Stem Cell Rescue)
2. Conventional consolidation and maintenance chemotherapy
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Primary outcome measure(s)
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1. Length of survival
2. Relapse rates
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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http://www.ctsu.ox.ac.uk/projects/leuk/ukallxii/new-4th-dec-2006/ukallxii-protocol-version-5-0.pdf
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Publications
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1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16556888
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/16421910
3. 2009 results on prospective outcome data in http://www.ncbi.nlm.nih.gov/pubmed/19244158
4. 2009 results on clinical and biological features of participants in http://www.ncbi.nlm.nih.gov/pubmed/19828704
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Contact name
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Professor
A
Goldstone
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Address
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University College Hospital
Gower Street
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City/town
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London
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Zip/Postcode
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WC1E 6AU
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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21/10/2009
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Date ISRCTN assigned
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25/10/2000
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