Acute Lymphoblastic Leukaemia Clinical Trial
— UKALL60+Official title:
A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia
Verified date | August 2023 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 126 |
Est. completion date | February 1, 2023 |
Est. primary completion date | December 21, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus MC | Rotterdam | |
United Kingdom | 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 | 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 | Arrowe Park Hospital | Wirral |
Lead Sponsor | Collaborator |
---|---|
University College, London | Cancer Research UK, Stichting Hemato-Oncologie voor Volwassenen Nederland |
Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Complete remission rate after 1 phase of induction | All patients will be assessed for their remission status at the end of Phase 1 induction. The CR rate at this timepoint will then be calculated. | Approximately 1 month after start of treatment | |
Secondary | Overall Survival at 1 year | Overall survival for all patients will be measured 1 year after registration | 1 year after registration | |
Secondary | Prognostic significance of molecularly determined minimal residual disease (MRD) at various time-points during therapy with respect to relapse occurrence. | MRD levels will be measured at distinct timepoints during the trial. | At diagnosis, 4 weeks, 8 weeks, 12 weeks after starting treatment | |
Secondary | Tolerability of treatment as determined by occurrence of key adverse effects | Patients in arms A-D will be assessed for adverse events at distinct timepoints during the trial | Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks after starting treatment | |
Secondary | Duration of in-patient hospitalisation | All patients will be assessed for the number of days they have spent as in-patients at distinct timepoints during the trial. | Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment and every 3 months during maintenance | |
Secondary | Relationship between performance status/co-morbidity and treatment option chosen | At registration | ||
Secondary | Quality of life aspects assessed at diagnosis/baseline at various time points | Registration, Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment, before starting maintenance and at the end of maintenance |
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