A randomised trial for adults with newly diagnosed acute lymphoblastic leuk... | Not Recruiting
A randomised trial for adults with ... | Not Recruiting
A randomised trial for adults with newly diagnosed acute lymphoblastic leukaemia
UKALL 14

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Medical Conditions
  • Topic: National Cancer Research Network
  • Subtopic: Haematological Oncology
  • Disease: Leukaemia (acute lymphoblastic)
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN66541317
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://cancerhelp.cancerresearchuk.org/trials/a-trial-treatment-adults-with-acute-lymphoblastic-leukaemia-UKALL14
Research Details
  • 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
Phase
Phase III
Study Design
Randomised interventional treatment trial
Study Type
Interventional
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 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
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned sample size: 720; UK sample size: 720
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)(p12’q24), t(8;22)(q24;q11)
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
W1T 4TJ
Trial Contact(s)
Primary Trial Contact
Ms Jo Gambell
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Sorry, this information is not available
EudraCT Number
2009-012717-22
Funder(s)
  • Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant (ref: C27995/A9609)
Other Study ID Numbers
7471
Sponsor(s)
University College London (UK)
Key Dates

Recruitment Start Date

01 Dec 2010

Recruitment End Date

31 Dec 2016

Trial Start Date

01 Dec 2010

Trial End Date

31 Dec 2016

Date added to source

23 Apr 2010

Date updated in source

01 Dec 2011