Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia
NCT ID: NCT00906945
Last Updated: 2017-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
39 participants
INTERVENTIONAL
2011-02-28
2015-09-30
Brief Summary
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Detailed Description
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1. Addition of G-CSF, which down regulates SDF-1 expression and acts synergistically with plerixafor in stem cell mobilization
2. Intravenous instead of subcutaneous dosing of plerixafor to improve kinetics of administration.
3. Dose escalation of plerixafor and twice daily dosing to maintain maximum CXCR4 blockade.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose Level 1
* G-CSF 10 mcg/kg SQ on Days 1-8
* Plerixafor 240 mcg/kg/d IV qd
* Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
* Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
* Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8
G-CSF
Plerixafor
Mitoxantrone
Etoposide
Cytarabine
Dose Level 2
* G-CSF 10 mcg/kg SQ on Days 1-8
* Plerixafor 320 mcg/kg/d IV qd
* Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
* Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
* Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8
G-CSF
Plerixafor
Mitoxantrone
Etoposide
Cytarabine
Dose Level 3
* G-CSF 10 mcg/kg SQ on Days 1-8
* Plerixafor 420 mcg/kg/d IV qd
* Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
* Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
* Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8
G-CSF
Plerixafor
Mitoxantrone
Etoposide
Cytarabine
Dose Level 4
* G-CSF 10 mcg/kg SQ on Days 1-8
* Plerixafor 560 mcg/kg/d IV qd
* Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
* Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
* Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8
G-CSF
Plerixafor
Mitoxantrone
Etoposide
Cytarabine
Dose Level 5
* G-CSF 10 mcg/kg SQ on Days 1-8
* Plerixafor 750 mcg/kg/d IV qd
* Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
* Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
* Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8
G-CSF
Plerixafor
Mitoxantrone
Etoposide
Cytarabine
MTD - Phase II
* G-CSF MTD determined in Phase 1 SQ on Days 1-8
* Plerixafor MTD determined in Phase 1 mcg/kg/d IV qd
* Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8
* Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8
* Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8
G-CSF
Plerixafor
Mitoxantrone
Etoposide
Cytarabine
Interventions
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G-CSF
Plerixafor
Mitoxantrone
Etoposide
Cytarabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary refractory disease following no more than 2 cycles of induction chemotherapy
* First relapse with no prior unsuccessful salvage chemotherapy
2. Age between 18 and 70 years old
3. ECOG performance status ≤ 3
4. Adequate organ function defined as:
* Calculated creatinine clearance ≥ 50 ml/min
* AST, ALT, total bilirubin ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (eg. hepatic infiltration or biliary obstruction due to leukemia)
* Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram
5. Are surgically or biologically sterile or willing to practice acceptable birth control, as follows:
* Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative serum or urine pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives and abstinence.
* Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period
6. Able to provide signed informed consent prior to registration on study
Exclusion Criteria
2. Peripheral blood blast count ≥ 20 x 103 /mm3
3. Active CNS involvement with leukemia
4. Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
5. Pregnant or nursing
6. Received any other investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within the preceding 2 weeks
7. Received colony stimulating factors filgrastim or sargramostim within 1 week or pegfilgrastim within 2 weeks of study
8. 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 L. Uy, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
MD Anderson Cancer Center
Houston, Texas, 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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10-0910 / 201106039
Identifier Type: -
Identifier Source: org_study_id
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