To identify a safe and tolerable standard of care protocol for patients >= 60 years old with de novo Acute Lymphoblastic Leukaemia (ALL).
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Complete remission rate after 2 phases of induction
Secondary outcome
* EFS at 1 year
* Treatment related mortality
* Complete remission rate after 1 phase of induction
* Prognostic significance of molecularly determined minimal residual disease
(MRD) at various timepoints during therapy with respect to relapse
occurrence.
* Overall Survival at 1 year
* Tolerability of treatment as determined by occurrence of key adverse effects
* Duration of in-patient hospitalisation
* Relationship between performance status/comorbidity and treatment option
chosen
* Quality of life aspects assessed at diagnosis/baseline at various time
points.
Background summary
Patients with ALL above 60-65 years are mostly given only palliative care
because of toxicity of the regular intensive chemotherapy. Studies with
intensive chemotherapy in this age group have shown poor survival rates of
maximally 20 % in presumably selected patients, a recent pilot study by HOVON
with an overall survival at 3 years of 50% probably being the exception. The
NCRI Adult ALL Group in the UK, in collaboration with HOVON, decided to
investigate the tolerability and feasibility of a standardised therapy protocol
for patients >60 years old, thereby defining a basic standard of care for
future studies.
Study objective
To identify a safe and tolerable standard of care protocol for patients >= 60
years old with de novo Acute Lymphoblastic Leukaemia (ALL).
Study design
A multicentre, prospective study. The treatment will be investigated
observational, the extra bone marrow aspirate is the intervention.
Study burden and risks
There may be some discomfort of the extra bone marrow punction. A bone marrow
puntction is usually only a little painful and then of short period of time.
You may experience some bruising and discomfort for a few days afterwards.
Completing the quality of life questionaire will take abouth 25 minutes.
Patient will be asked to complete the list 10 times.
Treatment of patients is not different than outside this study. (treatment of
ALL is heavy and has great risks. This is accountable because ALL is a life
threatening diseas.
University College London, Tottenham Court Road 90
London W1T 4TJ
GB
University College London, Tottenham Court Road 90
London W1T 4TJ
GB
Listed location countries
Age
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 study registration)
• Written informed consent
Exclusion criteria
• Known HIV infection
• Blast transformation of CML
• Mature B-cell leukemia i.e. Burkitt*s 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01616238 |
| CCMO | NL44500.078.14 |