A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia
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
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.
Observational Model: Cohort, Time Perspective: Prospective
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.
Approximately 2 months after start of treatment
United Kingdom: Medicines and Healthcare Products Regulatory Agency