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

Primary Purpose

Acute Myelogenous Leukemia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Interleukin-2
Sponsored by
Leo W. Jenkins Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring acute myelogenous leukemia, interleukin-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Leo W. Jenkins Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

interleukin-2

Arm Description

interleukin-2 therapy during lymphocyte recovery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 2, 2011
Last Updated
August 20, 2019
Sponsor
Leo W. Jenkins Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01289678
Brief Title
Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
Official Title
Phase II Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Unable to meet accrual goals
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
August 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Leo W. Jenkins Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia
Keywords
acute myelogenous leukemia, interleukin-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interleukin-2
Arm Type
Experimental
Arm Description
interleukin-2 therapy during lymphocyte recovery
Intervention Type
Drug
Intervention Name(s)
Interleukin-2
Other Intervention Name(s)
pulse
Intervention Description
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
Primary Outcome Measure Information:
Title
Event-free Survival
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Walker, MD
Organizational Affiliation
The Brody School of Medicine at East Carolina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leo W. Jenkins Cancer Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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