A Study for Older Adults With Acute Lymphoblastic Leukaemia

University College, London126 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Acute Lymphoblastic Leukaemia

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (34)

Erasmus MC

Rotterdam, Netherlands

NHS Lanarkshire - Monklands

Airdrie, United Kingdom

Blackpool Victoria Hopsital

Blackpool, United Kingdom

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Bradford Royal Infirmary

Bradford, United Kingdom

Bristol Haematology and Oncology Centre

Outcomes

Primary Outcomes

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.

Time frame: Approximately 2 months after start of treatment

Secondary Outcomes

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.

Time frame: Approximately 1 month after start of treatment

Overall Survival at 1 year

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

Time frame: 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.

Time frame: At diagnosis, 4 weeks, 8 weeks, 12 weeks after starting treatment

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

Time frame: Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks after starting treatment

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.

Time frame: Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment and every 3 months during maintenance

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