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Phase II Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myelogenous Leukemia

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Trial Information

Phase II Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Outcome Description:

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

Outcome Time Frame:

10 years

Safety Issue:

Yes

Principal Investigator

Paul Walker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Brody School of Medicine at East Carolina University

Authority:

United States: Institutional Review Board

Study ID:

LJCC 06-05

NCT ID:

NCT01289678

Start Date:

July 2006

Completion Date:

June 2020

Related Keywords:

  • Acute Myelogenous Leukemia
  • acute myelogenous leukemia
  • interleukin-2
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Leo W. Jenkins Cancer CenterGreenville, North Carolina