Acute lymphoblastic leukaemia (ALL) trial XII (joint trial with Eastern Co-operative Oncology Group - E2993)

ISRCTN	ISRCTN77346223
DOI	https://doi.org/10.1186/ISRCTN77346223
ClinicalTrials.gov (NCT)	NCT00002514
Clinical Trials Information System (CTIS)	2005-006181-31
Protocol serial number	G8223452, MREC/02/2/84
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof A Goldstone
Scientific

University College Hospital
Gower Street
London
WC1E 6AU
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	UKALLXII
Study objectives	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
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Leukaemia
Intervention	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
Intervention type	Other
Primary outcome measure(s)	1. Length of survival 2. Relapse rates
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/09/2008

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	550
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/01/1993
Date of final enrolment	30/09/2008

University College Hospital

London
WC1E 6AU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/07/2006		Yes	No
Results article	results	01/03/2007		Yes	No
Results article	results on prospective outcome data	07/05/2009		Yes	No
Results article	results on clinical and biological features of participants	10/12/2009		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes