A Pilot Study of G-CSF to Disrupt the Bone Marrow Microenvironment in Relapsed or Refractory Acute Lymphoblastic Leukemia

Inclusion Criteria:

- Acute lymphoblastic leukemia diagnosed according to WHO criteria (>25% lymphoblasts
in BM) which is relapsed or refractory to therapy. Patients with t(9;22) must be
refractory to BCR-ABL tyrosine kinase inhibitors.

- Age ≥ 18 years

- ECOG performance status ≤ 3.

- Adequate organ function defined as:

- Calculated creatinine clearance ≥ 50 ml/min

- AST, ALT, total bilirubin ≤ 2 x institutional ULN except when in the opinion of
treating physician elevated levels are due to direct involvement of leukemia (eg.
hepatic infiltration or biliary obstruction due to leukemia)

- Women of childbearing potential and sexually active males must be willing and able to
use effective contraception while on study.

- Able to provide signed informed consent prior to registration on study.

Exclusion Criteria:

- Active CNS involvement with leukemia

- Previous salvage chemotherapy with ifosfamide and etoposide

- Pregnant or nursing

- Received any other investigational agent or cytotoxic chemotherapy within the
preceding 2 weeks

- Received colony stimulating factors filgrastim or sargramostim within 1 week or
pegfilgrastim within 2 weeks of study

- Severe concurrent illness that would limit compliance with study requirements