A Study for Older Adults With Acute Lymphoblastic Leukaemia
UKALL60+
A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia
1 other identifier
interventional
126
2 countries
34
Brief Summary
The NCRI Adult ALL sub-group propose to collaborate with the Dutch/Belgian group HOVON to carry out a prospective, non randomised multi-arm study (including a choice of regimen intensity) to investigate the safety, tolerability and feasibility of a standardised therapy protocol for patients ≥ 60 years old with de novo ALL. The overall aim is define a basic standard of care upon which trials of novel therapies will be based in future. The design of the study will enable collection of a comprehensive dataset regarding the clinical outcome, Complete Response Rate (CR) and Minimal Residual Disease (MRD) response rates in a previously completely uncharacterised population, thus providing the essential platform for designing future randomised advanced phase studies in which new therapeutic approaches and novel therapies can be prospectively investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2012
Longer than P75 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 11, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedAugust 16, 2023
August 1, 2023
6.1 years
June 7, 2012
August 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Complete remission rate after 2 phases of induction
All patients will be assessed for their remission status at the end of Phase 2 induction. The CR rate at this timepoint will then be calculated.
Approximately 2 months after start of treatment
Secondary Outcomes (7)
Complete remission rate after 1 phase of induction
Approximately 1 month after start of treatment
Overall Survival at 1 year
1 year after registration
Prognostic significance of molecularly determined minimal residual disease (MRD) at various time-points during therapy with respect to relapse occurrence.
At diagnosis, 4 weeks, 8 weeks, 12 weeks after starting treatment
Tolerability of treatment as determined by occurrence of key adverse effects
Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks after starting treatment
Duration of in-patient hospitalisation
Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment and every 3 months during maintenance
- +2 more secondary outcomes
Study Arms (5)
Philadelphia Positive Patients
EXPERIMENTALAll patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen
Philadelphia -ve Patients- Intensive
EXPERIMENTALPatients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group.
Philadelphia -ve Patients- Intensive +
EXPERIMENTALPatients with Philadelphia negative disease and who are fit for intensive treatment will be entered into this group
Philadelphia -ve Patients- Non Intensive
EXPERIMENTALPatients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group
Registration only
NO INTERVENTIONPatients with either Philadelphia positive or negative ALL who do not wish to enter the study will be allocated to this group for data collection purposes only.
Interventions
Treatment for all pathways consists of Induction, Intensification (where applicable), Consolidation and Maintenance therapy during which combination chemotherapy is given for up to 2.5 years.
Eligibility Criteria
You may qualify if:
- Age ≥ 60 with Acute Lymphoblastic Leukaemia (ALL) OR ≥ 55 with Acute Lymphoblastic Leukaemia (ALL) unsuitable for the UKALL14 or HOVON 100 trial
- Newly diagnosed, previously untreated ALL (a steroid pre-phase of 5-7 days may be given before trial registration))
- Willing and able to give consent
You may not qualify if:
- Known HIV infection
- Blast transformation of CML
- Mature B-cell leukaemia i.e. Burkitts disease t(8,14)(q24 ;q32) and variant c-myc translocations e.g. t(2;8)(p12 ;q24), t(8;22)(q24;q11)
- Women who are pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- Cancer Research UKcollaborator
- Stichting Hemato-Oncologie voor Volwassenen Nederlandcollaborator
Study Sites (34)
Erasmus MC
Rotterdam, Netherlands
NHS Lanarkshire - Monklands
Airdrie, United Kingdom
Blackpool Victoria Hopsital
Blackpool, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Castle Hill Hospital
Cottingham, United Kingdom
Russells Hall Hospital
Dudley, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
NHS Lothian - Western General Hospital
Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
New Victoria Hospital and Southern General Hospital
Glasgow, United Kingdom
Northwick Park Hospital
Harrow, United Kingdom
St James' Hospital, Leeds
Leeds, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
St George's Hospital
London, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Arrowe Park Hospital
Metropolitan Borough of Wirral, United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom
Churchill Hospital, Oxford
Oxford, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Poole General Hospital
Poole, United Kingdom
St Helen's & Knowlsey Teaching Hospitals
Prescot, United Kingdom
Salisbury District Hospital
Salisbury, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Royal MarsdenHospital
Sutton, United Kingdom
Great Western Hospital
Swindon, United Kingdom
Musgrove Park
Taunton, United Kingdom
Torbay Hospital
Torquay, United Kingdom
Sandwell General Hospital
West Bromwich, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof Adele Fielding
University College London Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2012
First Posted
June 11, 2012
Study Start
December 1, 2012
Primary Completion
December 21, 2018
Study Completion
February 1, 2023
Last Updated
August 16, 2023
Record last verified: 2023-08