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Trial record 16 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

Clofarabine Bone Marrow Cytoreduction

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ClinicalTrials.gov Identifier: NCT00724009
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : March 18, 2014
Last Update Posted : March 18, 2014
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Intervention Drug: Clofarabine
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clofarabine
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 29
Completed 29 [1]
Not Completed 0
[1]
One patient underwent conditioning but died 1 day before stem cell infusion due to sepsis.
Arm/Group Title Clofarabine
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants
51
(23 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
13
  44.8%
Male
16
  55.2%
1.Primary Outcome
Title Cytoreductive Response
Hide Description Percent of patients achieving cytoreductive response of marrow cellularity <20% and blasts < 10%
Time Frame Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clofarabine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: percentage of participants
52
2.Secondary Outcome
Title Number of Participants With Renal Adverse Events
Hide Description Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clofarabine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
Grade 1-2 9
Grade 3-4 1
3.Secondary Outcome
Title Number of Participants With Hepatic (Total Bilirubin) Adverse Events
Hide Description Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clofarabine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
Grade 1-2 14
Grade 3-4 3
4.Secondary Outcome
Title Number of Participants With Hepatic (SGOT) Adverse Events
Hide Description Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clofarabine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
Grade 1-2 14
Grade 3-4 9
5.Secondary Outcome
Title Number of Participants With Cardiac Adverse Events
Hide Description Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clofarabine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
Grade 1-2 2
Grade 3-4 0
6.Secondary Outcome
Title Number of Participants With Skin Adverse Events
Hide Description Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clofarabine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
Grade 1-2 1
Grade 3-4 0
7.Secondary Outcome
Title Number of Participants Infection Adverse Events
Hide Description Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clofarabine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
Grade 3-4 11
Grade 5 1
8.Secondary Outcome
Title Leukemia Free Survival
Hide Description Time to event analysis used the day of transplant as day 0.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient with refractory AML underwent conditioning but died 1 day before stem cell infusion due to sepsis (grade 5 infection)
Arm/Group Title Clofarabine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 28
Median (95% Confidence Interval)
Unit of Measure: days
211
(171 to 342)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clofarabine
Hide Arm/Group Description

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.

All-Cause Mortality
Clofarabine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clofarabine
Affected / at Risk (%) # Events
Total   22/29 (75.86%)    
Hepatobiliary disorders   
Hepatic (total bilirubin)  3/29 (10.34%)  3
Hepatic (SGOT)  9/29 (31.03%)  9
Infections and infestations   
Infection  12/29 (41.38%)  12
Renal and urinary disorders   
Renal (creatine)  1/29 (3.45%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Clofarabine
Affected / at Risk (%) # Events
Total   26/29 (89.66%)    
Cardiac disorders   
Cardiac  2/29 (6.90%)  2
Hepatobiliary disorders   
Hepatic (total bilirubin)  14/29 (48.28%)  14
Hepatic (SGOT)  14/29 (48.28%)  14
Renal and urinary disorders   
Renal (creatinine)  9/29 (31.03%)  9
Skin and subcutaneous tissue disorders   
Skin  1/29 (3.45%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Stock, MD
Organization: The University of Chicago
Phone: 773-834-8982
EMail: wstock@medicine.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00724009     History of Changes
Other Study ID Numbers: 15809B
First Submitted: July 25, 2008
First Posted: July 29, 2008
Results First Submitted: January 30, 2014
Results First Posted: March 18, 2014
Last Update Posted: March 18, 2014