Phase 2
Completed N=39
Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia
Leukemia, Myeloid, Acute
Source: ClinicalTrials.gov NCT00906945 ↗
Enrolled (actual)
39
Serious AEs
22.9%
Results posted
Apr 2017
Primary outcomePrimary: Phase I: Maximum Tolerated Dose of Plerixafor Plus G-CSF When Combined With MEC — 750 mcg/kg/day
Summary
This study is designed to test the combination of Plerixafor with G-CSF for chemosensitization in patients with relapsed or refractory AML.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I: Maximum Tolerated Dose of Plerixafor Plus G-CSF When Combined With MEC |
750 | — |
| PRIMARY Phase II: Complete Response Rate (CR+CRi) |
30 | — |
| SECONDARY Phase I and Phase II: Safety and Tolerability of Regimen as Measured by Grade and Frequency of Adverse Events Exceeding 10% in Total Frequency |
0; 4; 9; 0; 0; 0 | — |
| SECONDARY Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery |
40 | — |
| SECONDARY Time to Hematologic Recovery as Measured by Time to Platelet Recovery |
32 | — |
| SECONDARY Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in White Blood Cells |
4.6 | — |
| SECONDARY Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in AML Blast Count |
9.4 | — |
| SECONDARY Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 1D9 Relative Mean Fluorescent Intensity |
8.0 | — |
| SECONDARY Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 12G5 Relative Mean Fluorescent Intensity |
0.9 | — |
| SECONDARY Time to Progression |
— | — |
| SECONDARY Time to Treatment Failure |
— | — |
| SECONDARY Overall Survival |
227 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00906945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.