Disrupting the Bone Marrow Microenvironment With G-CSF in Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the ability of G-CSF to disrupt the bone marrow microenvironment as a means to increase the efficacy of chemotherapy in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Lenograstim; Mesna; Sargramostim

Criteria

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:

• 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