Clinical trial NCT01616238: A Study for Older Adults With Acute Lymphoblastic Leukaemia
Official title: A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukaemia
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
name: Stichting Hemato-Oncologie voor Volwassenen Nederland
First posted: 2012-06-11
Enrollment: 126
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete remission rate after 2 phases of induction
timeFrame: Approximately 2 months after start of treatment
Secondary outcomes:
measure: Complete remission rate after 1 phase of induction
timeFrame: Approximately 1 month after start of treatment
measure: Overall Survival at 1 year
timeFrame: 1 year after registration
measure: Prognostic significance of molecularly determined minimal residual disease (MRD) at various time-points during therapy with respect to relapse occurrence.
timeFrame: At diagnosis, 4 weeks, 8 weeks, 12 weeks after starting treatment
measure: Tolerability of treatment as determined by occurrence of key adverse effects
timeFrame: Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks after starting treatment
measure: Duration of in-patient hospitalisation
timeFrame: Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment and every 3 months during maintenance
measure: Relationship between performance status/co-morbidity and treatment option chosen
timeFrame: At registration
measure: Quality of life aspects assessed at diagnosis/baseline at various time points
timeFrame: Registration, Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment, before starting maintenance and at the end of maintenance
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Airdrie
country: United Kingdom
facility: NHS Lanarkshire - Monklands
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hopsital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Edinburgh
country: United Kingdom
facility: NHS Lothian - Western General Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Glasgow
country: United Kingdom
facility: New Victoria Hospital and Southern General Hospital
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
city: Leeds
country: United Kingdom
facility: St James' Hospital, Leeds
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: Manchester
country: United Kingdom
facility: The Christie Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital, Oxford
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Poole
country: United Kingdom
facility: Poole General Hospital
city: Prescot
country: United Kingdom
facility: St Helen's & Knowlsey Teaching Hospitals
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: Sutton
country: United Kingdom
facility: Royal MarsdenHospital
city: Swindon
country: United Kingdom
facility: Great Western Hospital
city: Taunton
country: United Kingdom
facility: Musgrove Park
city: Torquay
country: United Kingdom
facility: Torbay Hospital
city: West Bromwich
country: United Kingdom
facility: Sandwell General Hospital
city: Wirral
country: United Kingdom
facility: Arrowe Park Hospital
Study officials:
affiliation: University College London Hospital
name: Prof Adele Fielding
role: PRINCIPAL_INVESTIGATOR
References: