Spots Global Cancer Trial Database for Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Immune Response and MRD in Acute Myeloid Leukemia

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Trial Identification

Brief Title: Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Immune Response and MRD in Acute Myeloid Leukemia

Official Title: Open-Label, Multicenter, Effects of Remission Maintenance Therapy With Ceplene® , Given in Conjunction With Low-Dose Interleukin-2, on Immune Response and Minimal Residual Disease in Adult Patients With AML in First Complete Remission

Study ID: NCT01347996

Conditions

Acute Myeloid Leukemia

Interventions

histamine dihydrochloride and IL-2

Study Description

Brief Summary: Ceplene/IL-2 remission maintenance therapy has been shown to significantly prolong Leukemia Free Survival in patients with Acute Myeloid Leukemia (AML) in first complete remission. This is an international, multicenter, open-label study to evaluate the effects of remission maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune system cells (T and NK cells) and prospectively defined markers of immune response that are known to reflect T and NK cell ability to combat AML.

Detailed Description: Outcome Measures: Primary: 1. To assess the quantitative and qualitative pharmacodynamic effects of Ceplene plus low-dose IL-2 (Ceplene/IL-2) by monitoring T and natural killer (NK) cell phenotypes and their functionality after the first and third treatment cycles in adult patients with acute myeloid leukemia (AML) in first complete remission (CR1). 2. To evaluate minimal residual disease (MRD) in AML patients receiving Ceplene/IL-2. Secondary: To document, in adult AML patients in CR1 treated with Ceplene/IL-2: 1. Leukemia-free survival (LFS) after a follow-up period of up to two years. 2. The safety of Ceplene/IL-2 therapy. 3. The potential relationship of Ceplene/IL-2 effects on T and NK cell phenotypes and their functionality to MRD.