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NCT Number: NCT01616238

A Study for Older Adults With Acute Lymphoblastic Leukaemia

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.

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Key information

Conditions

Acute Lymphoblastic Leukaemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Erasmus MC, Rotterdam, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

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 outcomes

  1. 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 outcomes

  1. 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.

  2. Overall Survival at 1 year

    Time frame: 1 year after registration

    Overall survival for all patients will be measured 1 year after registration

  3. 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.

  4. 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

  5. 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.

  6. Relationship between performance status/co-morbidity and treatment option chosen

    Time frame: At registration

  7. 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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Cancer Research UK
  • Stichting Hemato-Oncologie voor Volwassenen Nederland

Registry information

Official study title

A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia

Acronym: UKALL60+

Important dates

Study start
2012
Primary completion
2018
Study completion
2023
First posted
Jun 11, 2012
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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