Trial Outcomes & Findings for Clofarabine Bone Marrow Cytoreduction (NCT NCT00724009)

NCT ID: NCT00724009

Last Updated: 2014-03-18

Results Overview

Percent of patients achieving cytoreductive response of marrow cellularity \<20% and blasts \< 10%

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: Day 12
• Results posted on: 2014-03-18

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clofarabine Bone Marrow Cytoreduction

Baseline characteristics by cohort

Measure	Clofarabine n=29 Participants 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.
Age, Continuous	51 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 12

Percent of patients achieving cytoreductive response of marrow cellularity <20% and blasts < 10%

Outcome measures

Measure

Clofarabine n=29 Participants 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.

Cytoreductive Response

52 percentage of participants

SECONDARY outcome

Timeframe: Day 12

Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Measure	Clofarabine n=29 Participants 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.
Number of Participants With Renal Adverse Events Grade 1-2	9 participants
Number of Participants With Renal Adverse Events Grade 3-4	1 participants

SECONDARY outcome

Timeframe: Day 12

Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Measure	Clofarabine n=29 Participants 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.
Number of Participants With Hepatic (Total Bilirubin) Adverse Events Grade 1-2	14 participants
Number of Participants With Hepatic (Total Bilirubin) Adverse Events Grade 3-4	3 participants

SECONDARY outcome

Timeframe: Day 12

Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Measure	Clofarabine n=29 Participants 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.
Number of Participants With Hepatic (SGOT) Adverse Events Grade 1-2	14 participants
Number of Participants With Hepatic (SGOT) Adverse Events Grade 3-4	9 participants

SECONDARY outcome

Timeframe: Day 12

Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Measure	Clofarabine n=29 Participants 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.
Number of Participants With Cardiac Adverse Events Grade 1-2	2 participants
Number of Participants With Cardiac Adverse Events Grade 3-4	0 participants

SECONDARY outcome

Timeframe: Day 12

Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Measure	Clofarabine n=29 Participants 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.
Number of Participants With Skin Adverse Events Grade 1-2	1 participants
Number of Participants With Skin Adverse Events Grade 3-4	0 participants

SECONDARY outcome

Timeframe: Day 12

Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Measure	Clofarabine n=29 Participants 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.
Number of Participants Infection Adverse Events Grade 3-4	11 participants
Number of Participants Infection Adverse Events Grade 5	1 participants

SECONDARY outcome

Timeframe: 2 years

Population: One patient with refractory AML underwent conditioning but died 1 day before stem cell infusion due to sepsis (grade 5 infection)

Time to event analysis used the day of transplant as day 0.

Outcome measures

Measure

Clofarabine n=28 Participants 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.

Leukemia Free Survival

211 days Interval 171.0 to 342.0

Adverse Events

Clofarabine

Serious events: 22 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Clofarabine n=29 participants at risk 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.
Renal and urinary disorders Renal (creatine)	3.4% 1/29 • Number of events 1
Hepatobiliary disorders Hepatic (total bilirubin)	10.3% 3/29 • Number of events 3
Hepatobiliary disorders Hepatic (SGOT)	31.0% 9/29 • Number of events 9
Infections and infestations Infection	41.4% 12/29 • Number of events 12

Other adverse events

Measure	Clofarabine n=29 participants at risk 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.
Renal and urinary disorders Renal (creatinine)	31.0% 9/29 • Number of events 9
Hepatobiliary disorders Hepatic (total bilirubin)	48.3% 14/29 • Number of events 14
Hepatobiliary disorders Hepatic (SGOT)	48.3% 14/29 • Number of events 14
Cardiac disorders Cardiac	6.9% 2/29 • Number of events 2
Skin and subcutaneous tissue disorders Skin	3.4% 1/29 • Number of events 1

Additional Information

Wendy Stock, MD

The University of Chicago

Phone: 773-834-8982

Email: wstock@medicine.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place