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

Primary Purpose

Acute Lymphoblastic Leukaemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Chemotherapy
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukaemia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erasmus MC
  • NHS Lanarkshire - Monklands
  • Blackpool Victoria Hopsital
  • Royal Bournemouth Hospital
  • Bradford Royal Infirmary
  • Bristol Haematology and Oncology Centre
  • University Hospital of Wales
  • Castle Hill Hospital
  • Russells Hall Hospital
  • Ninewells Hospital
  • NHS Lothian - Western General Hospital
  • Beatson West of Scotland Cancer Centre
  • New Victoria Hospital and Southern General Hospital
  • Northwick Park Hospital
  • St James' Hospital, Leeds
  • Leicester Royal Infirmary
  • Royal Liverpool University Hospital
  • King's College Hospital NHS Foundation Trust
  • St Bartholomew's Hospital
  • St George's Hospital
  • The Christie Hospital
  • James Cook University Hospital
  • Churchill Hospital, Oxford
  • Derriford Hospital
  • Poole General Hospital
  • St Helen's & Knowlsey Teaching Hospitals
  • Salisbury District Hospital
  • Royal Hallamshire Hospital
  • Royal MarsdenHospital
  • Great Western Hospital
  • Musgrove Park
  • Torbay Hospital
  • Sandwell General Hospital
  • Arrowe Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Philadelphia Positive Patients

Philadelphia -ve Patients- Intensive

Philadelphia -ve Patients- Intensive +

Philadelphia -ve Patients- Non Intensive

Registration only

Arm Description

All patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen

Patients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group.

Patients with Philadelphia negative disease and who are fit for intensive treatment will be entered into this group

Patients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group

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.

Outcomes

Primary Outcome Measures

Complete remission rate after 2 phases of induction
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
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
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.
MRD levels will be measured at distinct timepoints during the trial.
Tolerability of treatment as determined by occurrence of key adverse effects
Patients in arms A-D will be assessed for adverse events at distinct timepoints during the trial
Duration of in-patient hospitalisation
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
Quality of life aspects assessed at diagnosis/baseline at various time points

Full Information

First Posted
June 7, 2012
Last Updated
August 15, 2023
Sponsor
University College, London
Collaborators
Cancer Research UK, Stichting Hemato-Oncologie voor Volwassenen Nederland
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1. Study Identification

Unique Protocol Identification Number
NCT01616238
Brief Title
A Study for Older Adults With Acute Lymphoblastic Leukaemia
Acronym
UKALL60+
Official Title
A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Cancer Research UK, Stichting Hemato-Oncologie voor Volwassenen Nederland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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; 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; establish national standards of care for this patient group; provide the essential platform for careful design of future randomised advanced phase studies of new therapeutic approaches and agents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Philadelphia Positive Patients
Arm Type
Experimental
Arm Description
All patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen
Arm Title
Philadelphia -ve Patients- Intensive
Arm Type
Experimental
Arm Description
Patients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group.
Arm Title
Philadelphia -ve Patients- Intensive +
Arm Type
Experimental
Arm Description
Patients with Philadelphia negative disease and who are fit for intensive treatment will be entered into this group
Arm Title
Philadelphia -ve Patients- Non Intensive
Arm Type
Experimental
Arm Description
Patients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group
Arm Title
Registration only
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete remission rate after 2 phases of induction
Description
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.
Time Frame
Approximately 2 months after start of treatment
Secondary Outcome Measure Information:
Title
Complete remission rate after 1 phase of induction
Description
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.
Time Frame
Approximately 1 month after start of treatment
Title
Overall Survival at 1 year
Description
Overall survival for all patients will be measured 1 year after registration
Time Frame
1 year after registration
Title
Prognostic significance of molecularly determined minimal residual disease (MRD) at various time-points during therapy with respect to relapse occurrence.
Description
MRD levels will be measured at distinct timepoints during the trial.
Time Frame
At diagnosis, 4 weeks, 8 weeks, 12 weeks after starting treatment
Title
Tolerability of treatment as determined by occurrence of key adverse effects
Description
Patients in arms A-D will be assessed for adverse events at distinct timepoints during the trial
Time Frame
Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks after starting treatment
Title
Duration of in-patient hospitalisation
Description
All patients will be assessed for the number of days they have spent as in-patients at distinct timepoints during the trial.
Time Frame
Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment and every 3 months during maintenance
Title
Relationship between performance status/co-morbidity and treatment option chosen
Time Frame
At registration
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Adele Fielding
Organizational Affiliation
University College London Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Facility Name
NHS Lanarkshire - Monklands
City
Airdrie
Country
United Kingdom
Facility Name
Blackpool Victoria Hopsital
City
Blackpool
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
Dudley
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
Country
United Kingdom
Facility Name
NHS Lothian - Western General Hospital
City
Edinburgh
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
Country
United Kingdom
Facility Name
New Victoria Hospital and Southern General Hospital
City
Glasgow
Country
United Kingdom
Facility Name
Northwick Park Hospital
City
Harrow
Country
United Kingdom
Facility Name
St James' Hospital, Leeds
City
Leeds
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
Country
United Kingdom
Facility Name
St George's Hospital
City
London
Country
United Kingdom
Facility Name
The Christie Hospital
City
Manchester
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
Country
United Kingdom
Facility Name
Churchill Hospital, Oxford
City
Oxford
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom
Facility Name
Poole General Hospital
City
Poole
Country
United Kingdom
Facility Name
St Helen's & Knowlsey Teaching Hospitals
City
Prescot
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
Country
United Kingdom
Facility Name
Royal MarsdenHospital
City
Sutton
Country
United Kingdom
Facility Name
Great Western Hospital
City
Swindon
Country
United Kingdom
Facility Name
Musgrove Park
City
Taunton
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay
Country
United Kingdom
Facility Name
Sandwell General Hospital
City
West Bromwich
Country
United Kingdom
Facility Name
Arrowe Park Hospital
City
Wirral
Country
United Kingdom

12. IPD Sharing Statement

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A Study for Older Adults With Acute Lymphoblastic Leukaemia

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