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

Completed · Early Phase 1

Conditions studied: Precursor Cell Lymphoblastic Leukemia-Lymphoma

In brief

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).

Key facts

Study ID

NCT01331590

Run by

Washington University School of Medicine

People needed

13

Starts

2011-07-01

Expected to finish

2015-11-01

Last updated by the study team

2016-09-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Chicago Medical Center — Chicago, Illinois, United States
• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.