Acute Lymphoblastic Leukaemia
Conditions
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 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.
Interventions
DRUGChemotherapy
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.
Sponsors
Cancer Research UK
Stichting Hemato-Oncologie voor Volwassenen Nederland
University College, London
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission rate after 2 phases of induction | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival at 1 year | 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. | 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 | 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 |
| Complete remission rate after 1 phase of induction | 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. |
| Relationship between performance status/co-morbidity and treatment option chosen | At registration | — |
| Quality of life aspects assessed at diagnosis/baseline at various time points | Registration, Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment, before starting maintenance and at the end of maintenance | — |
| Duration of in-patient hospitalisation | 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. |
Countries
Netherlands, United Kingdom
Outcome results
None listed