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Trial record 1 of 1 for:    NCT01331590
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Disrupting the Bone Marrow Microenvironment With G-CSF in Acute Lymphoblastic Leukemia

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 8, 2011
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
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).

Condition Intervention Phase
Precursor Cell Lymphoblastic Leukemia-Lymphoma Drug: G-CSF Drug: Ifosfamide Drug: Etoposide Drug: Dexamethasone Drug: Mesna Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of G-CSF to Disrupt the Bone Marrow Microenvironment in Relapsed or Refractory Acute Lymphoblastic Leukemia

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Treatment-related mortality [ Time Frame: 30 days after start of treatment ]
  • Delayed hematologic recovery [ Time Frame: Day 46 of treatment ]
    Defined as neutrophil recovery (ANC > 1,000/mm3) > 42 days after the start of chemotherapy in the absence of persistent leukemia

Secondary Outcome Measures:
  • Complete remission rate cytogenetic complete remission [ Time Frame: 42 days ]
  • Overall survival [ Time Frame: 2 years ]
    Every 6 months

  • Disease-free survival [ Time Frame: 2 years ]
    Every 6 months

  • Remission duration [ Time Frame: 2 years ]
    Every 6 months

  • Frequency and severity of adverse events [ Time Frame: 30 days post treatment ]
  • Interaction of pretreatment disease and patient characteristics on clinical outcomes [ Time Frame: Baseline ]
    Morphology, cytogenetics, immunophenotype, WBC, and performance status

Enrollment: 13
Study Start Date: July 2011
Study Completion Date: November 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G-CSF + Ifosfamide + Etoposide + Dexamethasone + Mesna

G-CSF = 10 mcg/kg/d SQ starting on day 1 and continuing until ANC >=1000/mcL x 2 days

Ifosfamide = 3330 mg/m2/d CIVI over 24 hours on Days 4-6

Etoposide = 150 mg/m2 IV over 2 hours BID on Days 4-6

Dexamethasone = 5 mg/m2 PO or IV BID on Days 4-10

Mesna = 2660 mg/m2/d continuous IV infusion over 24 hours on Days 4-6. 2000 mg/m2 continuous IV infusion over 12 hours on Day 7 to be started immediately after completion of ifosfamide.

Drug: G-CSF
Other Names:
  • Filgrastim
  • Neupogen
  • Granulocyte Colony-Stimulating Factor
  • Recombinant Methionyl Human G-CSF
Drug: Ifosfamide
Other Names:
  • Ifex
  • Isophosphamide
Drug: Etoposide
Other Names:
  • Etopophos
  • VP-16
Drug: Dexamethasone
Other Name: Decadron
Drug: Mesna
Other Name: Mesnex

Detailed Description:
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331590

United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Geoffrey Uy, M.D. Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01331590     History of Changes
Other Study ID Numbers: 201104323
First Submitted: March 31, 2011
First Posted: April 8, 2011
Last Update Posted: September 20, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Etoposide phosphate
Isophosphamide mustard
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors