A Study for Older Adults With Acute Lymphoblastic Leukaemia (UKALL60+)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by University College, London
Sponsor:
Collaborators:
Cancer Research UK
Stichting Hemato-Oncologie voor Volwassenen Nederland
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01616238
First received: June 7, 2012
Last updated: March 23, 2015
Last verified: March 2015
  Purpose

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.


Condition
Acute Lymphoblastic Leukaemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Complete remission rate after 2 phases of induction [ Time Frame: Approximately 2 months after start of treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Complete remission rate after 1 phase of induction [ Time Frame: Approximately 1 month after start of treatment ] [ Designated as safety issue: No ]
    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.

  • Overall Survival at 1 year [ Time Frame: 1 year after registration ] [ Designated as safety issue: No ]
    Overall survival for all patients will be measured 1 year after registration

  • Prognostic significance of molecularly determined minimal residual disease (MRD) at various time-points during therapy with respect to relapse occurrence. [ Time Frame: At diagnosis, 4 weeks, 8 weeks, 12 weeks after starting treatment ] [ Designated as safety issue: No ]
    MRD levels will be measured at distinct timepoints during the trial.

  • Tolerability of treatment as determined by occurrence of key adverse effects [ Time Frame: Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks after starting treatment ] [ Designated as safety issue: Yes ]
    Patients in arms A-D will be assessed for adverse events at distinct timepoints during the trial

  • Duration of in-patient hospitalisation [ Time Frame: Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment and every 3 months during maintenance ] [ Designated as safety issue: No ]
    All patients will be assessed for the number of days they have spent as in-patients at distinct timepoints during the trial.

  • Relationship between performance status/co-morbidity and treatment option chosen [ Time Frame: At registration ] [ Designated as safety issue: No ]
  • Quality of life aspects assessed at diagnosis/baseline at various time points [ Time Frame: Registration, Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment, before starting maintenance and at the end of maintenance ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Bone marrow aspirate and peripheral blood samples


Estimated Enrollment: 148
Study Start Date: December 2012
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Philadelphia Positive Patients
All patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen
Philadelphia -ve Patients- Intensive
Patients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group.
Philadelphia -ve Patients- Intensive +
Patients with Philadelphia negative disease and who are fit for intensive treatment will be entered into this group
Philadelphia -ve Patients- Non Intensive
Patients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group
Registration only
Patients 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.

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients over the age of 60 with acute lymphoblastic leukaemia.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616238

Contacts
Contact: UKALL60+ Trial Coordinator 0207 679 9860 ctc.ukall60@ucl.ac.uk

Locations
United Kingdom
NHS Lanarkshire - Monklands Recruiting
Airdrie, United Kingdom
Contact: Dr Lindsay Mitchell         
Blackpool Victoria Hopsital Recruiting
Blackpool, United Kingdom
Contact: Dr Paul Cahalin         
Royal Bournemouth Hospital Recruiting
Bournemouth, United Kingdom
Contact: Dr Joseph Chacko         
Bradford Royal Infirmary Recruiting
Bradford, United Kingdom
Contact: Dr Adrian Williams         
Bristol Haematology and Oncology Centre Recruiting
Bristol, United Kingdom
Contact: Prof. David Marks         
University Hospital of Wales Recruiting
Cardiff, United Kingdom
Contact: Dr Clare Rowntree         
Castle Hill Hospital Recruiting
Cottingham, United Kingdom
Contact: Dr Sara Ali         
Russells Hall Hospital Recruiting
Dudley, United Kingdom
Contact: Dr Craig Taylor         
Ninewells Hospital Recruiting
Dundee, United Kingdom
Contact: Dr Sudhir Tauro         
NHS Lothian - Western General Hospital Recruiting
Edinburgh, United Kingdom
Contact: Dr Huw Roddie         
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom
Contact: Dr Mark Drummond         
New Victoria Hospital and Southern General Hospital Recruiting
Glasgow, United Kingdom
Contact: Dr Anne Morrison         
Northwick Park Hospital Recruiting
Harrow, United Kingdom
Contact: Dr Nicki Panoskaltsis         
St James' Hospital, Leeds Recruiting
Leeds, United Kingdom
Contact: Prof. David Bowen         
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom
Contact: Dr Ann Hunter         
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom
Contact: Prof. Richard Clark         
St Bartholomew's Hospital Recruiting
London, United Kingdom
Contact: Dr Matt Smith         
St George's Hospital Recruiting
London, United Kingdom
Contact: Dr Matthias Klammer         
The Royal Free Hospital Recruiting
London, United Kingdom
Contact: Dr Adele Fielding         
The Christie Hospital Recruiting
Manchester, United Kingdom
Contact: Dr Samar Kulkarni         
James Cook University Hospital Recruiting
Middlesbrough, United Kingdom
Contact: Dr Diane Plews         
Churchill Hospital, Oxford Recruiting
Oxford, United Kingdom
Contact: Dr Andy Peniket         
Derriford Hospital Recruiting
Plymouth, United Kingdom
Contact: Dr Hannah Hunter         
Poole General Hospital Recruiting
Poole, United Kingdom
Contact: Dr Fergus Jack         
St Helen's & Knowlsey Teaching Hospitals Recruiting
Prescot, United Kingdom
Contact: Dr JAT Nicholson         
Salisbury District Hospital Recruiting
Salisbury, United Kingdom
Contact: Dr Jonathan Cullis         
Royal Hallamshire Hospital Recruiting
Sheffield, United Kingdom
Contact: Dr Nick Morley         
Great Western Hospital Recruiting
Swindon, United Kingdom
Contact: Dr Norbert Blesing         
Musgrove Park Recruiting
Taunton, United Kingdom
Contact: Dr Simon Bolam         
Torbay Hospital Recruiting
Torquay, United Kingdom
Contact: Dr Deborah Turner         
The Hillingdon Hospital Recruiting
Uxbridge, United Kingdom
Contact: Dr Richard Kaczmarski         
Sandwell General Hospital Recruiting
West Bromwich, United Kingdom
Contact: Dr Yasmin Hasan         
Arrowe Park Hospital Recruiting
Wirral, United Kingdom
Contact: Dr Barbara Hammer         
Sponsors and Collaborators
University College, London
Cancer Research UK
Stichting Hemato-Oncologie voor Volwassenen Nederland
Investigators
Principal Investigator: Dr Adele Fielding Royal Free Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01616238     History of Changes
Other Study ID Numbers: UCL/11/0532
Study First Received: June 7, 2012
Last Updated: March 23, 2015
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 03, 2015