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Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00906945
First received: May 13, 2009
Last updated: February 14, 2017
Last verified: February 2017
Results First Received: December 20, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Leukemia, Myeloid, Acute
Interventions: Drug: G-CSF
Drug: Plerixafor
Drug: Mitoxantrone
Drug: Etoposide
Drug: Cytarabine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened to participant enrollment on 02/04/2011 and closed to participant enrollment on 08/19/2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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
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
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
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
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
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

Participant Flow:   Overall Study
    Dose Level 1   Dose Level 2   Dose Level 3   Dose Level 4   Dose Level 5   MTD - Phase II
STARTED   3   3   3   7   7   16 
COMPLETED   3   3   3   6   6   14 
NOT COMPLETED   0   0   0   1   1   2 
Found to be not eligible                0                0                0                1                1                1 
Physician Decision                0                0                0                0                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
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
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
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
Dose Level 5 (Includes MTD-Phase II)
  • 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
Total Total of all reporting groups

Baseline Measures
   Dose Level 1   Dose Level 2   Dose Level 3   Dose Level 4   Dose Level 5 (Includes MTD-Phase II)   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   3   3   6   20   35 
Age 
[Units: Years]
Median (Full Range)
 63 
 (59 to 65) 
 47 
 (43 to 50) 
 64 
 (24 to 67) 
 54 
 (34 to 59) 
 56 
 (29 to 70) 
 56 
 (24 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      2  66.7%      2  66.7%      1  33.3%      4  66.7%      8  40.0%      17  48.6% 
Male      1  33.3%      1  33.3%      2  66.7%      2  33.3%      12  60.0%      18  51.4% 
Region of Enrollment 
[Units: Participants]
           
United States   3   3   3   6   20   35 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Phase I: Maximum Tolerated Dose of Plerixafor Plus G-CSF When Combined With MEC   [ Time Frame: Completion of Phase I enrollment (17 months) ]

2.  Primary:   Phase II: Complete Response Rate (CR+CRi)   [ Time Frame: 45 days ]

3.  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   [ Time Frame: 30 days following end of treatment ]

4.  Secondary:   Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery   [ Time Frame: Up to 62 days after treatment ]

5.  Secondary:   Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery   [ Time Frame: Up to 62 days after treatment ]

6.  Secondary:   Time to Hematologic Recovery as Measured by Time to Platelet Recovery   [ Time Frame: Up to 62 days after treatment ]

7.  Secondary:   Time to Hematologic Recovery as Measured by Time to Platelet Recovery   [ Time Frame: Up to 62 days after treatment ]

8.  Secondary:   Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in White Blood Cells   [ Time Frame: 6 hours after plerixafor ]

9.  Secondary:   Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in AML Blast Count   [ Time Frame: 6 hours after plerixafor ]

10.  Secondary:   Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 1D9 Relative Mean Fluorescent Intensity   [ Time Frame: 6 hours after plerixafor ]

11.  Secondary:   Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 12G5 Relative Mean Fluorescent Intensity   [ Time Frame: 6 hours after plerixafor ]

12.  Secondary:   Time to Progression   [ Time Frame: 2 years ]

13.  Secondary:   Time to Treatment Failure   [ Time Frame: 8 days ]

14.  Secondary:   Overall Survival   [ Time Frame: Median follow-up was 34.6 months ]

15.  Post-Hoc:   Relapse Free-survival Rate   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Geoffrey Uy, M.D.
Organization: Washington University School of Medicine
phone: 314-454-8304
e-mail: guy@wustl.edu



Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00906945     History of Changes
Other Study ID Numbers: 10-0910 / 201106039
Study First Received: May 13, 2009
Results First Received: December 20, 2016
Last Updated: February 14, 2017