Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00822770
First received: January 13, 2009
Last updated: June 13, 2014
Last verified: June 2014
Results First Received: June 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Stem Cell Transplantation
Leukemia
Interventions: Drug: Plerixafor
Drug: Filgrastim
Drug: Fludarabine
Drug: Busulfan
Procedure: Allogeneic blood stem cell transplant
Drug: ATG (Thymoglobulin)

  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
Recruitment Period:

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
Plerixafor + G-CSF

ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant

Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)

Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.

Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.

Thymoglobulin (ATG) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.

Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.

Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.

Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I


Participant Flow:   Overall Study
    Plerixafor + G-CSF  
STARTED     47  
COMPLETED     47  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
Plerixafor + G-CSF

ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant

Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)

Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.

Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.

ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.

Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.

Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.

Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I


Baseline Measures
    Plerixafor + G-CSF  
Number of Participants  
[units: participants]
  47  
Age  
[units: years]
Median ( Full Range )
  56  
  ( 25 to 65 )  
Gender  
[units: participants]
 
Female     21  
Male     26  
Region of Enrollment  
[units: participants]
 
United States     47  



  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) Plerixafor   [ Time Frame: 28 day cycle (Plerixafor Day -7 to Day -4) ]

2.  Secondary:   Time to Failure   [ Time Frame: Baseline till disease progression/death, up to 1 year. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Response Rate (Engraftment Versus Graft Failure)   [ Time Frame: 100 Days post engraftment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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: Marina Konopleva, MD, PhD / Associate Professor
Organization: The University of Texas (UT) MD Anderson Cancer Center
phone: 713-794-1628
e-mail: mkonople@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00822770     History of Changes
Other Study ID Numbers: 2007-0772
Study First Received: January 13, 2009
Results First Received: June 13, 2014
Last Updated: June 13, 2014
Health Authority: United States: Food and Drug Administration