Acute Myelogenous Leukemia
Conditions
Keywords
acute myelogenous leukemia, interleukin-2
Brief summary
Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.
Detailed description
Upon lymphocyte recovery after myeloablative induction standard chemotherapy pulse Interleukin-2 administered
Interventions
DRUGInterleukin-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
Sponsors
Leo W. Jenkins Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed hematopathology diagnosis of AML receiving marrow suppressive treatment * Total WBC recovery of 500 mm3 prior to IL-2 treatment * Platelet count of at least 20,000 mm3 prior to starting IL-2 treatment * Active infection controlled prior to starting IL-2 treatment * Stable systolic blood pressure \> 90mm Hg prior to starting IL-2 treatment * O2 saturation \>90% prior to starting treatment * Stable cardiopulmonary status prior to starting IL-2 treatment * Serum creatinine \< or equal to 2.0 mg/dl * Total bilirubin and AST \<3x upper limits normal
Exclusion criteria
* Acute Promyelocytic Leukemia * Active thrombocytopenic bleeding * Cardiac ejection fraction below 45% * Pregnancy and/or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free Survival | 3 years | Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 6 |
Baseline characteristics
| Characteristic | Interleukin-2 | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 6 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Age, Continuous | 57 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 12 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Event-free Survival
Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interleukin-2 | Event-free Survival | 5 Participants |