Trial Outcomes & Findings for Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia (NCT NCT01289678)

Results Overview

Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

3 years

Results posted on

2019-09-12

Participant milestones
Measure	Interleukin-2 interleukin-2 therapy during lymphocyte recovery Interleukin-2: Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days
Overall Study STARTED	18
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	6

Reasons for withdrawal
Measure	Interleukin-2 interleukin-2 therapy during lymphocyte recovery Interleukin-2: Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days
Overall Study Physician Decision	6

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Interleukin-2 n=12 Participants interleukin-2 therapy during lymphocyte recovery Interleukin-2: Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=12 Participants
Age, Categorical >=65 years	6 Participants n=12 Participants
Age, Continuous	57 years n=12 Participants
Sex: Female, Male Female	8 Participants n=12 Participants
Sex: Female, Male Male	4 Participants n=12 Participants
Region of Enrollment United States	12 participants n=12 Participants

Timeframe: 3 years

Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death

Outcome measures
Measure	Interleukin-2 n=12 Participants interleukin-2 therapy during lymphocyte recovery Interleukin-2: Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days
Event-free Survival	5 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Adverse event data not reported

Adverse event data not reported

Brody School of Medicine

Phone: 2527441888