Trial Outcomes & Findings for Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed AML Patients Over 65 (NCT NCT02341495)

Results Overview

The Complete Remission Rate for all evaluable patients will be reported for the following treatment: azacitadine, vitamin D, and deferasirox (Exjade). The proportion of patients experiencing per-protocol CR will be calculated with a 90% exact confidence interval.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

up to 5 years

Results posted on

2020-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Drug Treatment Deferasirox (20mg/kg/day)on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Cholecalciferol(4,000 units/day), on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol, repeated every four weeks for 8 cycles given either subcutaneously or IV Deferasirox: Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO Cholecalciferol: Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO Azacitidine: Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed AML Patients Over 65

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Drug Treatment n=4 Participants Deferasirox (20mg/kg/day)on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Cholecalciferol(4,000 units/day), on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol, repeated every four weeks for 8 cycles given either subcutaneously or IV Deferasirox: Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO Cholecalciferol: Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO Azacitidine: Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 5 years

Population: No patients were analyzed as study was terminated early due to low accrual. Therefore, data necessary for planned analyses were not collected.

The Complete Remission Rate for all evaluable patients will be reported for the following treatment: azacitadine, vitamin D, and deferasirox (Exjade). The proportion of patients experiencing per-protocol CR will be calculated with a 90% exact confidence interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 5 years

Population: No patients were analyzed as study was terminated early due to low accrual. Therefore, data necessary for planned analyses were not collected.

Characterization of the safety of an induction regimen of azacitidine in combination with vitamin D and deferasirox (Exjade). The proportion of patients experiencing severe adverse events, and the number of patients experiencing severe adverse events probably or definitely related to treatment will be determined. Adverse events will be tabulated by category and graded by NCI CTCAE version 4.0

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 5 years

Population: No patients were analyzed as study was terminated early due to low accrual. Therefore, data necessary for planned analyses were not collected.

The overall survival and relapse-free survival functions. Product-limit (Kaplan-Meier) estimate of the survival functions will be estimated, with 90% confidence intervals.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 5 years

Population: No patients were analyzed as study was terminated early due to low accrual. Therefore, data necessary for planned analyses were not collected.

The length of time for remission after achieving complete remission

Outcome measures

Outcome data not reported

Adverse Events

Drug Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elizabeth Henry

Loyola University Medical Center

Phone: 708-327-3153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place