Acute lymphoblastic leukaemia (ALL) trial XII (joint trial with Eastern Co-operative Oncology Group - E2993)
| ISRCTN | ISRCTN77346223 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77346223 |
| EudraCT/CTIS number | 2005-006181-31 |
| ClinicalTrials.gov number | NCT00002514 |
| Secondary identifying numbers | G8223452, MREC/02/2/84 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 21/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Professor A Goldstone
Scientific
Scientific
University College Hospital
Gower Street
London
WC1E 6AU
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 1. Length of survival 2. Relapse rates |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/01/1993 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University College Hospital
London
WC1E 6AU
United Kingdom
WC1E 6AU
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| 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 |
