Clofarabine Bone Marrow Cytoreduction

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00724009
First received: July 25, 2008
Last updated: January 30, 2014
Last verified: January 2014
Results First Received: January 30, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Intervention: Drug: Clofarabine

  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
No text entered.

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
Clofarabine

Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days

Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line.


Participant Flow:   Overall Study
    Clofarabine  
STARTED     29  
COMPLETED     29 [1]
NOT COMPLETED     0  
[1] One patient underwent conditioning but died 1 day before stem cell infusion due to sepsis.



  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
Clofarabine

Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days

Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line.


Baseline Measures
    Clofarabine  
Number of Participants  
[units: participants]
  29  
Age  
[units: years]
Median ( Full Range )
  51  
  ( 23 to 69 )  
Gender  
[units: participants]
 
Female     13  
Male     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cytoreductive Response   [ Time Frame: Day 12 ]

2.  Secondary:   Number of Participants With Renal Adverse Events   [ Time Frame: Day 12 ]

3.  Secondary:   Number of Participants With Hepatic (Total Bilirubin) Adverse Events   [ Time Frame: Day 12 ]

4.  Secondary:   Number of Participants With Hepatic (SGOT) Adverse Events   [ Time Frame: Day 12 ]

5.  Secondary:   Number of Participants With Cardiac Adverse Events   [ Time Frame: Day 12 ]

6.  Secondary:   Number of Participants With Skin Adverse Events   [ Time Frame: Day 12 ]

7.  Secondary:   Number of Participants Infection Adverse Events   [ Time Frame: Day 12 ]

8.  Secondary:   Leukemia Free Survival   [ Time Frame: 2 years ]


  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
No text entered.  


Results Point of Contact:  
Name/Title: Wendy Stock, MD
Organization: The University of Chicago
phone: 773-834-8982
e-mail: wstock@medicine.bsd.uchicago.edu


No publications provided


Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00724009     History of Changes
Other Study ID Numbers: 15809B
Study First Received: July 25, 2008
Results First Received: January 30, 2014
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board