An Open-Label, Study of Remission Maintenance Therapy With Ceplene® (Histamine), and Low-Dose Interleukin-2, on Immune Response and Minimal Residual Disease in Patients With Acute Myeloid Leukemia in First Complete Remission (CR1)
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Minimal residual disease (MRD) in AML patients receiving Ceplene/IL-2
A second primary objective of this study is to evaluate MRD in patients who are receiving remission maintenance therapy with Ceplene/IL-2. MRD will be evaluated using RQ-PCR for molecular detection of genetic markers of AML. Patients' MRD status will be quantified at the time of enrollment (baseline) and within ten days after completion of Cycles 3, 5, 6, 7, 9 and 10 of Ceplene/IL-2 therapy, corresponding to approximately every 3 months during this immunotherapy.
Comparison at baseline and various time points up to 2 years
No
Robin FOA, MD, PhD
Study Chair
Università degli Studi di Roma "La Sapienza" Dipartimento di Biotecnologie Cellulari ed Ematolgia
Sweden: Medical Products Agency
EPC2008-02
NCT01347996
July 2009
June 2015
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