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


N/A
18 Years
N/A
Open (Enrolling)
Both
Precursor Cell Lymphoblastic Leukemia-Lymphoma

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Trial Information

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


In this study, we will combine G-CSF as priming prior to and during the administration of
salvage chemotherapy regimen in ALL. Abundant data suggests that leukemic cells receive key
growth and survival signals from the bone marrow microenvironment. Our preclinical data
show that 4-5 days of G-CSF treatment is associated with a loss of osteoblasts and decreases
expression of key chemokine/ cytokines which support lymphocyte development. The
investigators hypothesize that G-CSF will disrupt the protective effects of the bone marrow
microenvironment and augment the effect of chemotherapy in adults with ALL. This is a pilot
study of G-CSF priming in adult patients with relapsed or refractory ALL to determine the
feasibility and to characterize the effect of G-CSF treatment on the marrow
microenvironment.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment-related mortality

Outcome Time Frame:

30 days after start of treatment

Safety Issue:

Yes

Principal Investigator

Geoffrey Uy, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

201104323

NCT ID:

NCT01331590

Start Date:

September 2011

Completion Date:

September 2015

Related Keywords:

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

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
University of Chicago Medical CenterChicago, Illinois  60637