Know Cancer

forgot password

A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia

60 Years
Not Enrolling
Acute Lymphoblastic Leukaemia

Thank you

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:


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:



United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

September 2012

Completion Date:

Related Keywords:

  • Acute Lymphoblastic Leukaemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma