A Study for Older Adults With Acute Lymphoblastic Leukaemia

Acute Lymphoblastic Leukaemia Clinical Trial

— UKALL60+  

Official title:

A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616238
• Other study ID #: UCL/11/0532
• Status: Completed
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: February 1, 2023

Study information

• Verified date: August 2023
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will

1. establish baseline expectations for Event Free Survival (EFS), Overall Survival (OS), MRD responses and quality of life measures for older patients of all ages and pre-morbid states;

2. disclose how best to use knowledge of pre-morbid characteristics to apply the appropriate intensity of therapy in order to balance the best disease related outcomes against quality of life;

3. establish national standards of care for this patient group;

4. provide the essential platform for careful design of future randomised advanced phase studies of new therapeutic approaches and agents.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukaemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Chemotherapy
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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	Cancer Research UK, Stichting Hemato-Oncologie voor Volwassenen Nederland

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

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