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Chemosensitization With Plerixafor Plus G-CSF in Relapsed or Refractory Acute Myeloid Leukemia

Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Leukemia, Myeloid, Acute

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Trial Information

Chemosensitization With Plerixafor Plus G-CSF in Relapsed or Refractory Acute Myeloid Leukemia

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 microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic
chemotherapy. In this study, we seek to maximize blockage of the SDF-1/CXCR4 axis through
the following:

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

3. Dose escalation of plerixafor and twice daily dosing to maintain maximum CXCR4

Inclusion Criteria:

1. Acute myeloid leukemia diagnosed by WHO criteria with one of the following:

- Primary refractory disease following ≥ 1 round of induction chemotherapy

- First relapse or higher

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: i. 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

ii. 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:

1. Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants)

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: To determine the maximum tolerated dose of plerixafor plus G-CSF when combined with MEC in patients with relapsed or refractory AML

Outcome Time Frame:

45 days after start of treatment

Safety Issue:


Principal Investigator

Geoffrey L. Uy, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:

10-0910 / 201106039



Start Date:

February 2011

Completion Date:

June 2016

Related Keywords:

  • Leukemia, Myeloid, Acute
  • stem cell mobilization
  • chemosensitization
  • CXCR4
  • SDF-1
  • CXCL-12
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



MD Anderson Cancer CenterHouston, Texas  77030-4096
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Washington UniversitySt. Louis, Missouri  63110