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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 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: May 5, 2017
Last verified: May 2017
  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 Intervention Phase
Acute Lymphoblastic Leukaemia Drug: Chemotherapy Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • 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 ]

Estimated Enrollment: 148
Study Start Date: December 2012
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Philadelphia Positive Patients
All patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen
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.
Experimental: Philadelphia -ve Patients- Intensive
Patients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group.
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.
Experimental: Philadelphia -ve Patients- Intensive +
Patients with Philadelphia negative disease and who are fit for intensive treatment will be entered into this group
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.
Experimental: Philadelphia -ve Patients- Non Intensive
Patients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group
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.
No Intervention: 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)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Netherlands
Erasmus MC Suspended
Rotterdam, Netherlands
United Kingdom
NHS Lanarkshire - Monklands Suspended
Airdrie, United Kingdom
Blackpool Victoria Hopsital Recruiting
Blackpool, United Kingdom
Contact: Dr Paul Cahalin         
Royal Bournemouth Hospital Suspended
Bournemouth, United Kingdom
Bradford Royal Infirmary Suspended
Bradford, United Kingdom
Bristol Haematology and Oncology Centre Suspended
Bristol, United Kingdom
University Hospital of Wales Suspended
Cardiff, United Kingdom
Castle Hill Hospital Suspended
Cottingham, United Kingdom
Russells Hall Hospital Suspended
Dudley, United Kingdom
Ninewells Hospital Suspended
Dundee, United Kingdom
NHS Lothian - Western General Hospital Suspended
Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre Suspended
Glasgow, United Kingdom
New Victoria Hospital and Southern General Hospital Suspended
Glasgow, United Kingdom
Northwick Park Hospital Suspended
Harrow, United Kingdom
St James' Hospital, Leeds Recruiting
Leeds, United Kingdom
Contact: Prof. David Bowen         
Leicester Royal Infirmary Suspended
Leicester, United Kingdom
Royal Liverpool University Hospital Suspended
Liverpool, United Kingdom
King's College Hospital NHS Foundation Trust Suspended
London, United Kingdom
St Bartholomew's Hospital Suspended
London, United Kingdom
St George's Hospital Suspended
London, United Kingdom
The Christie Hospital Recruiting
Manchester, United Kingdom
Contact: Dr Samar Kulkarni         
James Cook University Hospital Suspended
Middlesbrough, United Kingdom
Churchill Hospital, Oxford Suspended
Oxford, United Kingdom
Derriford Hospital Recruiting
Plymouth, United Kingdom
Contact: Dr Hannah Hunter         
Poole General Hospital Suspended
Poole, United Kingdom
St Helen's & Knowlsey Teaching Hospitals Suspended
Prescot, United Kingdom
Salisbury District Hospital Suspended
Salisbury, United Kingdom
Royal Hallamshire Hospital Suspended
Sheffield, United Kingdom
Royal MarsdenHospital Suspended
Sutton, United Kingdom
Great Western Hospital Suspended
Swindon, United Kingdom
Musgrove Park Recruiting
Taunton, United Kingdom
Contact: Dr Simon Bolam         
Torbay Hospital Suspended
Torquay, United Kingdom
The Hillingdon Hospital Withdrawn
Uxbridge, United Kingdom
Sandwell General Hospital Suspended
West Bromwich, United Kingdom
Arrowe Park Hospital Suspended
Wirral, United Kingdom
Sponsors and Collaborators
University College, London
Cancer Research UK
Stichting Hemato-Oncologie voor Volwassenen Nederland
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: May 5, 2017

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 June 22, 2017