A Study for Older Adults With Acute Lymphoblastic Leukaemia
- Conditions
- Acute Lymphoblastic Leukaemia
- Interventions
- Drug: Chemotherapy
- Registration Number
- NCT01616238
- Lead Sponsor
- University College, London
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Philadelphia Positive Patients Chemotherapy All patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen Philadelphia -ve Patients- Intensive + Chemotherapy Patients with Philadelphia negative disease and who are fit for intensive treatment will be entered into this group Philadelphia -ve Patients- Intensive Chemotherapy Patients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group. Philadelphia -ve Patients- Non Intensive Chemotherapy Patients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 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.
Relationship between performance status/co-morbidity and treatment option chosen At registration 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.
Overall Survival at 1 year 1 year after registration Overall survival for all patients will be measured 1 year after registration
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
Trial Locations
- 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
🇬🇧Bristol, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Castle Hill Hospital
🇬🇧Cottingham, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, United Kingdom
Ninewells Hospital
🇬🇧Dundee, United Kingdom
Scroll for more (24 remaining)Erasmus MC🇳🇱Rotterdam, Netherlands