Condition category
Cancer
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
01/12/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Ms Jo Gambell

ORCID ID

Contact details

Haematology Trials Group
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom

Additional identifiers

EudraCT number

2009-012717-22

ClinicalTrials.gov number

NCT01085617

Protocol/serial number

7471

Study information

Scientific title

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

West London REC 2 approved on the 13th January 2010 (ref: 09/H0711/90)

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Leukaemia (acute lymphoblastic)

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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

01/12/2010

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 720; UK sample size: 720

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)(p12’q24), t(8;22)(q24;q11)

Recruitment start date

01/12/2010

Recruitment end date

31/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Haematology Trials Group
London
W1T 4TJ
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant (ref: C27995/A9609)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes