Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation

This study has been terminated.
(Low accrual)
Sponsor:
Collaborator:
ESP Pharma
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00363467
First received: August 10, 2006
Last updated: August 24, 2011
Last verified: August 2011
Results First Received: August 9, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Acute Myeloid Leukemia (AML)
Interventions: Drug: G-CSF
Drug: Leukapheresis
Drug: Busulfan
Procedure: Stem cell reinfusion

  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 May 15, 2006 through May 20, 2009; H. Lee Moffitt Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study did not involve a wash-out period or group assignment.

Reporting Groups
  Description
Autologous Hematopoietic Progenitor Cell Transplantation G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion

Participant Flow:   Overall Study
    Autologous Hematopoietic Progenitor Cell Transplantation  
STARTED     3  
COMPLETED     2  
NOT COMPLETED     1  
Physician Decision                 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
Autologous Hematopoietic Progenitor Cell Transplantation G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion

Baseline Measures
    Autologous Hematopoietic Progenitor Cell Transplantation  
Number of Participants  
[units: participants]
  3  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 2.828427  
Age, Customized  
[units: participants]
 
Between 18 and 65 years     2  
>=65 years     1  
Gender  
[units: participants]
 
Female     1  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   100-day Non-relapse Mortality   [ Time Frame: 100 days post transplant ]

2.  Secondary:   Successful Autologous Stem Cell Collection   [ Time Frame: At time of stem cell collection ]

3.  Secondary:   Severe Regimen-related Toxicity   [ Time Frame: up to 100 days post translant ]

4.  Secondary:   1 Year Event-free Survival   [ Time Frame: 1 year post transplant ]

5.  Secondary:   1 Year Overall Survival   [ Time Frame: 1 year post transplant ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
Two patients enrolled and transplanted out of 24 targeted transplant accrual goal. Due to poor enrollment study closed and no further analyses were conducted.  


Results Point of Contact:  
Name/Title: Jeffrey Lancet MD
Organization: H. Lee Moffitt Cancer Center
phone: 813-745-6841
e-mail: Jeffrey.Lancet@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00363467     History of Changes
Other Study ID Numbers: MCC-14604
Study First Received: August 10, 2006
Results First Received: August 9, 2010
Last Updated: August 24, 2011
Health Authority: United States: Food and Drug Administration