Trial Outcomes & Findings for Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in Remission (NCT NCT01465386)

Last Updated: 2017-04-04

Results Overview

Number of days from enrollment to recurrence of acute myeloid leukemia as determined by the reappearance of blasts in the blood or marrow

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2017-04-04

Participant milestones
Measure	Treated Patients Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. bortezomib: Given SC
Overall Study STARTED	6
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	4

Reasons for withdrawal
Measure	Treated Patients Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. bortezomib: Given SC
Overall Study Lack of Efficacy	3
Overall Study Adverse Event	1

Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in Remission

Baseline characteristics by cohort
Measure	Treatment (Enzyme Inhibitor Therapy) n=6 Participants Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. bortezomib: Given SC
Age, Continuous	78 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

Timeframe: Up to 2 years

Population: Patient who began maintenance treatment with bortezomib after induction of remission

Number of days from enrollment to recurrence of acute myeloid leukemia as determined by the reappearance of blasts in the blood or marrow

Outcome measures
Measure	Treated Patients n=6 Participants Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. bortezomib: Given SC
Progression Free Survival (PFS)	107 days Interval 14.0 to 575.0

Serious events: 2 serious events

Other events: 1 other events

Deaths: 5 deaths

Serious adverse events
Measure	Treatment (Enzyme Inhibitor Therapy) n=6 participants at risk Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. bortezomib: Given SC
Nervous system disorders Altered Mental Status	16.7% 1/6 • Number of events 1 • 1 year
Gastrointestinal disorders Cholechystitis	16.7% 1/6 • Number of events 1 • 1 year

Other adverse events
Measure	Treatment (Enzyme Inhibitor Therapy) n=6 participants at risk Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. bortezomib: Given SC
Nervous system disorders Peripheral neuropathy	16.7% 1/6 • Number of events 1 • 1 year

FHCRC

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