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Phase I/II Trial of Fludarabine Plus Busulfan and Allogeneic Progenitor Cell Support

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00506857
First received: July 23, 2007
Last updated: January 24, 2012
Last verified: January 2012
History of Changes
Results First Received: January 24, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hematologic Malignancies
Interventions: Drug: Busulfan
Drug: Fludarabine

  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: November 2003 to August 2011. All recruitment was done at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 82 participants enrolled, two (2) participants were excluded from the trial before starting treatment.

Reporting Groups
  Description
Busulfan + Fludarabine Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.

Participant Flow:   Overall Study
    Busulfan + Fludarabine  
STARTED     80  
COMPLETED     80  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Busulfan + Fludarabine Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.

Baseline Measures
    Busulfan + Fludarabine  
Number of Participants  
[units: participants]
 		  80  
Age  
[units: years]
Median ( Full Range ) 		  56  
  ( 10 to 71 )  
Gender  
[units: participants]
 		 
Female     26  
Male     54  
Region of Enrollment  
[units: participants]
 		 
United States     80  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: 1 month ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Graft Versus Host Disease (GVHD)   [ Time Frame: 5 years ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  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
No text entered.  


Results Point of Contact:  
Name/Title: Richard E. Champlin/Professor
Organization: UT MD Anderson Cancer Center
e-mail: ytdinh@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00506857     History of Changes
Other Study ID Numbers: DM99-251
Study First Received: July 23, 2007
Results First Received: January 24, 2012
Last Updated: January 24, 2012
Health Authority: United States: Institutional Review Board