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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Leo W. Jenkins Cancer Center
Sponsor:
Information provided by (Responsible Party):
Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier:
NCT01289678
First received: February 2, 2011
Last updated: October 20, 2014
Last verified: October 2014

February 2, 2011
October 20, 2014
July 2006
December 2017   (final data collection date for primary outcome measure)
Event-free survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death
Same as current
Complete list of historical versions of study NCT01289678 on ClinicalTrials.gov Archive Site
Patient response [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Response:

Morphologic Complete Remission (CR)

Same as current
Not Provided
Not Provided
 
Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
Phase II Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myelogenous Leukemia
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
Experimental: interleukin-2
interleukin-2 therapy during lymphocyte recovery
Intervention: Drug: Interleukin-2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
14
June 2020
December 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01289678
LJCC 06-05
Yes
Leo W. Jenkins Cancer Center
Leo W. Jenkins Cancer Center
Not Provided
Principal Investigator: Paul Walker, MD The Brody School of Medicine at East Carolina University
Leo W. Jenkins Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP