Trial Outcomes & Findings for Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia (NCT NCT01960387)

Results Overview

Number of patients with newly diagnosed Acute Myeloid Leukemia who achieved Complete Response to therapy as determined by bone marrow biopsy evaluation. A CR designation required that the patient achieved a morphologic leukemia-free state and an absolute neutrophil count greater than or equal to 1.0 x 10\^9/l, a platelet count greater than or equal to 100 x 10\^9/l, and no evidence of extramedullary disease.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Between 14 and 28 days from start of study treatment

Results posted on

2016-08-02

Participant Flow

Participant milestones

Participant milestones
Measure	Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day) Patients with newly diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m\^2 daily plus cytarabine at a dose of 1g/m\^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day) n=2 Participants Patients with newly diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m\^2 daily plus cytarabine at a dose of 1g/m\^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Between 14 and 28 days from start of study treatment

Population: Newly diagnosed Acute Myeloid Leukemia patients who received clofarabine (1-2 hour intravenous infusion of 40mg/m2 daily dose) plus cytarabine (2-4 hours maximum intravenous infusion of 1g/m2 daily dose) starting 3-4 hours post completion of clofarabine administration on days 1 through 5, who were evaluable for response by bone marrow biopsy.

Number of patients with newly diagnosed Acute Myeloid Leukemia who achieved Complete Response to therapy as determined by bone marrow biopsy evaluation. A CR designation required that the patient achieved a morphologic leukemia-free state and an absolute neutrophil count greater than or equal to 1.0 x 10\^9/l, a platelet count greater than or equal to 100 x 10\^9/l, and no evidence of extramedullary disease.

Outcome measures

Outcome measures
Measure	Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day) n=2 Participants Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m\^2 daily plus Cytarabine at a dose of 1g/m\^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
Complete Clinical Response	2 participants

SECONDARY outcome

Timeframe: Up to 24 months

Population: Results data are not available due to low/insufficient subject accrual from early \[trial\] termination.

Number of months of survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m\^2/Day) + Cytarabine (1g/m\^2/Day).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: Results data are not available due to low/insufficient subject accrual from early \[trial\] termination.

Number of months of relapse free survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m\^2/Day) + Cytarabine (1g/m\^2/Day).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year

Population: Results data are not available due to low/insufficient subject accrual from early \[trial\] termination.

Evaluation of potential factors that are predictive of clinical response in newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m\^2/Day) + Cytarabine (1g/m\^2/Day).

Outcome measures

Outcome data not reported

Adverse Events

Clofarabine (40mg/m2/Day) + Cytarabine (1g/m2/Day)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clofarabine (40mg/m2/Day) + Cytarabine (1g/m2/Day) n=2 participants at risk Patients with Newly Diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m2 daily plus cytarabine at a dose of 1g/m2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration, on days 1 through 5.
Blood and lymphatic system disorders Febrile neutropenia	50.0% 1/2
Infections and infestations Lung infection	50.0% 1/2

Other adverse events

Adverse event data not reported

Additional Information

Michael Boyiadzis, MD

University of Pittsburgh Cancer Institute

Phone: 412-623-0040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place