Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has suspended participant recruitment.
Sponsor:
Collaborators:
Cancer Research UK
Stichting Hemato-Oncologie voor Volwassenen Nederland
Herlev Hospital
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01616238
First received: June 7, 2012
Last updated: April 8, 2016
Last verified: April 2016
  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, peripheral blood samples and buccal swabs for constitutional DNA analysis

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:   55 Years and older   (Adult, Senior)
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 (or over 55 and unsuitable for the UKALL14 trial)
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

Locations
Netherlands
Erasmus MC
Rotterdam, Netherlands
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 Royal Free 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
The Hillingdon Hospital
Uxbridge, United Kingdom
Sandwell General Hospital
West Bromwich, United Kingdom
Arrowe Park Hospital
Wirral, United Kingdom
Sponsors and Collaborators
University College, London
Cancer Research UK
Stichting Hemato-Oncologie voor Volwassenen Nederland
Herlev Hospital
Investigators
Principal Investigator: Prof Adele Fielding University College London Hospital
  More Information

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: April 8, 2016
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on December 09, 2016