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

Leo W. Jenkins Cancer Center

Status and phase: Terminated; Phase 2

Conditions: Acute Myelogenous Leukemia

Treatments: Drug: Interleukin-2

Study type: Interventional

Funder types: Other

Identifiers

NCT01289678

LJCC 06-05

Details and patient eligibility

About

Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.

Full description

Upon lymphocyte recovery after myeloablative induction standard chemotherapy pulse Interleukin-2 administered

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

interleukin-2

Experimental group

Description:

interleukin-2 therapy during lymphocyte recovery

Treatment:

Drug: Interleukin-2