Clinical Trials /

A Study for Older Adults With Acute Lymphoblastic Leukaemia

NCT01616238

Description:

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.

Related Conditions:
  • Acute Lymphoblastic Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study for Older Adults With Acute Lymphoblastic Leukaemia
  • Official Title: A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia

Clinical Trial IDs

  • ORG STUDY ID: UCL/11/0532
  • NCT ID: NCT01616238

Conditions

  • Acute Lymphoblastic Leukaemia

Interventions

DrugSynonymsArms
ChemotherapyPhiladelphia Positive Patients

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Philadelphia Positive PatientsExperimentalAll patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen
  • Chemotherapy
Philadelphia -ve Patients- IntensiveExperimentalPatients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group.
  • Chemotherapy
Philadelphia -ve Patients- Intensive +ExperimentalPatients with Philadelphia negative disease and who are fit for intensive treatment will be entered into this group
  • Chemotherapy
Philadelphia -ve Patients- Non IntensiveExperimentalPatients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group
  • Chemotherapy
Registration onlyNo InterventionPatients 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.

    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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:55 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Complete remission rate after 2 phases of induction
    Time Frame:Approximately 2 months after start of treatment
    Safety Issue:
    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.

    Secondary Outcome Measures

    Measure:Complete remission rate after 1 phase of induction
    Time Frame:Approximately 1 month after start of treatment
    Safety Issue:
    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.
    Measure:Overall Survival at 1 year
    Time Frame:1 year after registration
    Safety Issue:
    Description:Overall survival for all patients will be measured 1 year after registration
    Measure: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
    Safety Issue:
    Description:MRD levels will be measured at distinct timepoints during the trial.
    Measure: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
    Safety Issue:
    Description:Patients in arms A-D will be assessed for adverse events at distinct timepoints during the trial
    Measure: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
    Safety Issue:
    Description:All patients will be assessed for the number of days they have spent as in-patients at distinct timepoints during the trial.
    Measure:Relationship between performance status/co-morbidity and treatment option chosen
    Time Frame:At registration
    Safety Issue:
    Description:
    Measure: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
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:University College, London

    Last Updated

    May 5, 2017