A randomised trial for adults with newly diagnosed acute lymphoblastic leukaemia
| ISRCTN | ISRCTN66541317 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66541317 |
| EudraCT/CTIS number | 2009-012717-22 |
| ClinicalTrials.gov number | NCT01085617 |
| Secondary identifying numbers | 7471 |
- Submission date
- 23/04/2010
- Registration date
- 23/04/2010
- Last edited
- 02/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Contact information
Scientific
CRUK and UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
| Phone | +44 (0)207 679 9169 |
|---|---|
| ukall14@ctc.ucl.ac.uk |
Study information
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised trial for adults with newly diagnosed acute lymphoblastic leukaemia |
| Study acronym | UKALL 14 |
| Study hypothesis | 1.1. 1B (precursor-B lineage): to determine if the addition of rituximab to standard induction chemotherapy results in improved event-free survival (EFS) in patients with precursor B-cell lineage acute lymphoblastic leukaemia (ALL) 1.2. 1T (T lineage): to determine if the addition of nelarabine following standard induction therapy (arms T1 and T2) improves outcome for patients with T cell ALL 2. To determine the tolerability of Pegylated asparaginase in induction (for all patients) and to compare anti-asparaginase antibody levels between patients in the 2 randomisation groups from aim 1B 3. To determine whether risk-adapted introduction of unrelated donor HSCT (myeloablative conditioning in patients aged up to and including 40 years at time of study entry and non-myeloablative conditioning in patients aged greater than 40 years, i.e., having reached their 41st birthday at time of study entry) result in greater EFS for patients at highest risk of relapse 4. To compare 2 schedules of administration (standard P1 versus 'collapsed' P2) of keratinocyte growth factor (palifermin) for efficacy in preventing the severe mucosal toxicity of etoposide/TBI HSCT conditioning regimen |
| Ethics approval(s) | West London REC 2, 13/01/2010, ref: 09/H0711/90 |
| Condition | Acute lymphoblastic leukaemia |
| Intervention | Rituximab: To determine if the addition of monoclonal antibody to standard induction chemotherapy results in improved EFS in patients with precursor B-cell lineage ALL Nelarabine: To determine if the addition of nelarabine following standard induction therapy (arms T 1 and T2) improves outcome for patients with T cell ALL Oncaspar: To determine the tolerability of pegylated asparaginase in induction (for all patients) and to compare anti-asparaginase 1. Rituximab: 375 mg/m2 given by IV on days 3, 10, 17 and 24 of Phase 1 induction therapy 2. Oncaspar: 1000 IU/m2 given by IV on days 4 and 18 of Phase 1 induction therapy 3. Nelarabine: 1.5 g/m2 given by IV on days 1, 3 and 5 immediately following Phase 2 induction therapy 4. Palifermin: 60 ug/kg given either on days -10, -9, -8, 0, 2 and 4 or -9, 0, 2 and 4 of myeloablative conditioning regimen Total duration of treatment is approximately 2 years 6 months for all patients who complete treatment. Patients are followed up until death. |
| Intervention type | Other |
| Primary outcome measure | 1. Event free survival (applies to all interventions), measured from date of randomisation until the date of relapse 2. Toxicity related to pegylated asparaginase, measured after Phase 1 induction therapy |
| Secondary outcome measures | 1. Anti-asparaginase antibodies (induction randomisation only), measured at the end of Phase 1 induction therapy 2. Overall survival, measured from date of randomisation until date of death 3. Complete remission rate: % of patients in complete remission at the end of Phase 2 induction therapy |
| Overall study start date | 01/06/2008 |
| Overall study end date | 31/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned sample size: 811; UK sample size: 811 |
| Participant inclusion criteria | 1. Subjects must be aged greater than or equal to 25 and less than or equal to 65 years old with acute lymphoblastic leukaemia, either sex 2. Newly diagnosed, previously untreated ALL (a steroid pre-phase of 5 - 7 days is acceptable and can be started prior to registration) 3. Written informed consent |
| Participant exclusion criteria | 1. Known HIV infection 2. Pregnant or lactating women 3. Blast transformation of CML 4. Mature B-cell leukemia, i.e. Burkitt's disease t(8,14)(q24 ;q32) and all disorders amplification of c-myc, e.g. t(2;8)(p12q24), t(8;22)(q24;q11) |
| Recruitment start date | 30/12/2010 |
| Recruitment end date | 31/12/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
W1T 4TJ
United Kingdom
Sponsor information
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
| Website | http://www.ucl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 31/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | In line with the CR UK and UCL CTC policy the unit is committed to supporting safe and appropriate sharing and requests for access to the participant level data should be made by contacting the relevant Trials Group Lead, Director or Deputy Director. All requests will be assessed by the relevant Chief Investigator/Trial Management Group and, if necessary, Trial Steering Committee and/or CTC Senior Management Group. Please see the UCL CTC website for further details: http://www.ctc.ucl.ac.uk/DataSampleSharing.aspx |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/07/2018 | 25/06/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
02/12/2020: IPD sharing statement added.
01/12/2020: Trial website added.
17/06/2020: The scientific contact details have been changed.
25/06/2019: Publication reference added.
03/04/2019: The condition has been changed from "Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Leukaemia (acute lymphoblastic)" to "Acute lymphoblastic leukaemia" following a request from the NIHR.
23/11/2018: The following changes were made:
1. The recruitment end date was changed from 26/07/2018 to 31/12/2020.
2. The overall trial end date was changed from 31/12/2023 to 31/07/2022.
3. The intention to publish date was changed from 31/12/2024 to 31/07/2023.
07/08/2018: The following changes were made to the trial record:
1. The target number of participants was changed from "Planned sample size: 720; UK sample size: 720" to "Planned sample size: 811; UK sample size: 811"
2. The total target enrolment was changed from 720 to 811
3. The recruitment end date was changed from 30/06/2018 to 26/07/2018
12/02/2018: The following changes were made:
1. Overall trial start date was changed from 01/12/2010 to 01/06/2008.
2. Recruitment start date was changed from 01/12/2010 to 30/12/2010.
3. Recruitment end date was changed from 31/12/2016 to 30/06/2018.
4. Overall trial end date was changed from 31/12/2016 to 31/12/2023.
5. Publication and dissemination plan, intention to publish date and participant level data were added.
