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Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation

This study has been terminated.
(Low accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00363467
First Posted: August 15, 2006
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ESP Pharma
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
Results First Submitted: August 9, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
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 
Overall Participants Analyzed 
[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 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  33.3% 
Male      2  66.7% 
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


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


  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: Jeffrey Lancet MD
Organization: H. Lee Moffitt Cancer Center
phone: 813-745-6841
e-mail: Jeffrey.Lancet@moffitt.org



Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00363467     History of Changes
Other Study ID Numbers: MCC-14604
First Submitted: August 10, 2006
First Posted: August 15, 2006
Results First Submitted: August 9, 2010
Results First Posted: September 30, 2011
Last Update Posted: March 23, 2017



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