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

L

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)

18 participants in 1 patient group

interleukin-2
Experimental group
Description:
interleukin-2 therapy during lymphocyte recovery
Treatment:
Drug: Interleukin-2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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