Status:
COMPLETED
Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia
Lead Sponsor:
Washington University School of Medicine
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is designed to test the combination of Plerixafor with G-CSF for chemosensitization in patients with relapsed or refractory AML.
Detailed Description
In this study, we are seeking to target the leukemia microenvironment to overcome disease resistance. We hypothesize that by disrupting the interaction of leukemic blasts with the bone marrow microenv...
Eligibility Criteria
Inclusion
- Acute myeloid leukemia diagnosed by WHO criteria with one of the following:
- Primary refractory disease following no more than 2 cycles of induction chemotherapy
- First relapse with no prior unsuccessful salvage chemotherapy
- Age between 18 and 70 years old
- ECOG performance status ≤ 3
- 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
- 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
- Able to provide signed informed consent prior to registration on study
Exclusion
- Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants)
- Peripheral blood blast count ≥ 20 x 103 /mm3
- Active CNS involvement with leukemia
- Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
- Pregnant or nursing
- Received any other investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00906945
Start Date
February 1 2011
End Date
September 1 2015
Last Update
April 4 2017
Active Locations (3)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Washington University
St Louis, Missouri, United States, 63110
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030