A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia
60 Years
N/A
Both
Acute Lymphoblastic Leukaemia
Trial Information
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
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.
Inclusion Criteria:
- Age ≥ 60 with Acute Lymphoblastic Leukaemia (ALL)
- 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Complete remission rate after 2 phases of induction
Outcome Description:
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.
Outcome Time Frame:
Approximately 2 months after start of treatment
Safety Issue:
No
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
UCL/11/0532
NCT ID:
NCT01616238
Start Date:
September 2012
Completion Date:
Related Keywords:
- Acute Lymphoblastic Leukaemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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