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

Acute Myelogenous Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01289678
• Other study ID #: LJCC 06-05
• Status: Terminated
• Phase: Phase 2
• Start date: July 2006
• Est. completion date: August 31, 2016

Study information

• Verified date: March 2017
• Source: Leo W. Jenkins Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Leo W. Jenkins Cancer Center	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Leo W. Jenkins Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	3 years