Trial Outcomes & Findings for Clofarabine and Cytarabine in Treating Patients With Acute Myeloid Leukemia With Minimal Residual Disease (NCT NCT00863434)

NCT ID: NCT00863434

Last Updated: 2017-05-15

Results Overview

Percent of white blood cells that are blasts in the bone marrow post-treatment.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: Post-treatment
• Results posted on: 2017-05-15

Participant Flow

Participant milestones

Measure	Treatment (Colony Stimulating Factor and Chemotherapy) Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity. clofarabine: Given IV cytarabine: Given IV filgrastim: Given SC
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clofarabine and Cytarabine in Treating Patients With Acute Myeloid Leukemia With Minimal Residual Disease

Baseline characteristics by cohort

Measure	Treatment (Colony Stimulating Factor and Chemotherapy) n=2 Participants Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity. clofarabine: Given IV cytarabine: Given IV filgrastim: Given SC
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
Minimal Residual Disease (blast %) as Assessed by Bone Marrow Flow Cytometry	4.35 percent of white blood cells n=5 Participants

PRIMARY outcome

Timeframe: Post-treatment

Percent of white blood cells that are blasts in the bone marrow post-treatment.

Outcome measures

Measure	Treatment (Colony Stimulating Factor and Chemotherapy) n=2 Participants Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity. clofarabine: Given IV cytarabine: Given IV filgrastim: Given SC
Minimal Residual Disease as Assessed by Bone Marrow Flow Cytometry	1.8 percent of white blood cells Interval 0.2 to 3.4

PRIMARY outcome

Timeframe: Every 3 months for 2 years, and then annually for 3 years

Outcome measures

Measure	Treatment (Colony Stimulating Factor and Chemotherapy) n=2 Participants Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity. clofarabine: Given IV cytarabine: Given IV filgrastim: Given SC
Disease-free Survival	6.43 months Interval 3.27 to 9.6

PRIMARY outcome

Timeframe: Every 3 months for 2 years, and then annually for 3 years

Outcome measures

Measure	Treatment (Colony Stimulating Factor and Chemotherapy) n=2 Participants Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity. clofarabine: Given IV cytarabine: Given IV filgrastim: Given SC
Overall Survival	9.73 months Interval 8.27 to 11.2

Adverse Events

Treatment (Colony Stimulating Factor and Chemotherapy)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment (Colony Stimulating Factor and Chemotherapy) n=2 participants at risk Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity. clofarabine: Given IV cytarabine: Given IV filgrastim: Given SC
Psychiatric disorders Exacerbation of depression	50.0% 1/2 • Number of events 1
General disorders Left shoulder pain	50.0% 1/2 • Number of events 1
Skin and subcutaneous tissue disorders Macular Rash	50.0% 1/2 • Number of events 1

Additional Information

Pamela Becker, MD, PhD

University of Washington

Phone: 206-288-7273

Email: pbecker@uw.edu

Results disclosure agreements

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