A Study for Older Adults With Acute Lymphoblastic Leukaemia | Recruiting
A Study for Older Adults With Acute... | Recruiting
A Study for Older Adults With Acute Lymphoblastic Leukaemia
UKALL60+

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Medical Conditions
  • Acute Lymphoblastic Leukaemia
Primary Contact Details
UKALL60+ Trial Coordinator
0207 679 9860
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01616238
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
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.
Research Details
  • 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.
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Chemotherapy

Study Arm Groups : Philadelphia Positive Patients, Philadelphia -ve Patients- Intensive, Philadelphia -ve Patients- Intensive +, Philadelphia -ve Patients- Non Intensive

Intervention Type
See Interventions above
Primary Outcome Measures
    Complete remission rate after 2 phases of induction; Approximately 2 months after start of treatment
Secondary Outcome Measures
    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; Relationship between performance status/co-morbidity and treatment option chosen; At registration; 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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
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
All
Age Range
55 Years - N/A
Who Can Participate
Patients
Number of Participants
148
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
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)
Local Institution
Glasgow
Central
Local Institution
Plymouth
Devon
Local Institution
London
Greater London
Local Institution
Oxford
Oxfordshire
Manchester
Edinburgh
Harrow
Heart & Chest Hospital
Liverpool
Cardiff
Sheffield
Leeds
Sutton
Blackpool
Lancashire
Hull Clinical Trials Unit
Cottingham
East Yorkshire
Uni Hospital Leicester
Leicester
Great Western Hospital
Swindon
Bristol
Bradford Royal Infirmary
Bradford
Research Site
Wirral
Ninewells Hospital
Dundee
Torquay
Airdrie
Dudley
Taunton
Royal Bournemouth
Bournemouth
The James Cook University Hospital
Middlesbrough
Poole General Hospital
Poole
Salisbury District Hospital
Salisbury
The Hillingdon Hospitals NHS FOUNDATION TRUST
Uxbridge
Research Site
Prescot
Research Site
West Bromwich
Trial Contact(s)
Primary Trial Contact
UKALL60+ Trial Coordinator
0207 679 9860
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Netherlands, 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
A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia
EudraCT Number
Not available for this trial
Funder(s)
  • Cancer Research UK
  • Stichting Hemato-Oncologie voor Volwassenen Nederland
Other Study ID Numbers
UCL/11/0532
Sponsor(s)
University College, London
Key Dates

Recruitment Start Date

Dec 2012

Recruitment End Date

Dec 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

07 Jun 2012

Date updated in source

05 May 2017