IV Plerixafor With Mitoxantrone Etoposide and Cytarabine for Acute Myeloid Leukemia (AML)
NCT ID: NCT01027923
Last Updated: 2015-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
6 participants
INTERVENTIONAL
2010-05-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose Level 1
Mitoxantrone 8 mg/m2/day IV over 30 minutes once daily on days 1-5
Plerixafor 320 mcg/kg/day IV over 30 minutes on days 0-5
Etoposide 100 mg/m2/day IV over 60 minutes once daily on days 1-5
Cytarabine 1000 mg/m2/day IV over 60 minutes once daily on days 1-5
Plerixafor
Mitoxantrone
Etoposide
Cytarabine
Dose Level 2
Mitoxantrone 8 mg/m2/day IV over 30 minutes once daily on days 1-5
Plerixafor 420 mcg/kg/day IV over 30 minutes on days 0-5
Etoposide 100 mg/m2/day IV over 60 minutes once daily on days 1-5
Cytarabine 1000 mg/m2/day IV over 60 minutes once daily on days 1-5
Plerixafor
Mitoxantrone
Etoposide
Cytarabine
Dose Level 3
Mitoxantrone 8 mg/m2/day IV over 30 minutes once daily on days 1-5
Plerixafor 560 mcg/kg/day IV over 30 minutes on days 0-5
Etoposide 100 mg/m2/day IV over 60 minutes once daily on days 1-5
Cytarabine 1000 mg/m2/day IV over 60 minutes once daily on days 1-5
Plerixafor
Mitoxantrone
Etoposide
Cytarabine
Interventions
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Plerixafor
Mitoxantrone
Etoposide
Cytarabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary refractory disease following ≥ 1 round of induction chemotherapy
* First relapse or higher
* Age between 18 and 70 years
* ECOG performance status ≤ 2
* Adequate organ function defined as:
* Creatinine ≤ 1.5 x institutional ULN
* AST ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
* ALT ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
* Total bilirubin ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
* Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram
* 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
* Peripheral blood blast count ≥ 50 x 103 /mm3
* Active CNS involvement with leukemia
* Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
* Pregnant or nursing
* Concurrently receiving any other investigational agent
* Received colony stimulating factors filgrastim or sargramostim within 48 hours or pegfilgrastim within 14 days of study
* Less than 2 weeks from the completion of any previous cytotoxic chemotherapy (excluding hydroxyurea)
* Severe concurrent illness that would limit compliance with study requirements
18 Years
70 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Geoffrey Uy, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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09-1825 / 201101703
Identifier Type: -
Identifier Source: org_study_id
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