Who is sponsoring NCT01347996?

NCT01347996 is sponsored by Cytovia, Inc..

What condition does NCT01347996 study?

NCT01347996 studies Acute Myeloid Leukemia.

What drugs are being tested in NCT01347996?

Interventions: histamine dihydrochloride and IL-2.

What is the status of NCT01347996?

NCT01347996 is currently COMPLETED.

Last reviewed 2017-11-27 · How we verify

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

NCT01347996 Phase 4 COMPLETED

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.

Details

Lead sponsor	Cytovia, Inc.
Phase	Phase 4
Status	COMPLETED
Enrolment	84
Start date	2009-07
Completion	2014-06

Conditions

Acute Myeloid Leukemia

Interventions

histamine dihydrochloride and IL-2

Primary outcomes

Minimal residual disease (MRD) in AML patients receiving Ceplene/IL-2 — Comparison at baseline and various time points up to 2 years
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.
Pharmacodynamic effects of Ceplene plus low dose IL-2 (Ceplene/IL-2) by monitoring T and NK cell phenotypes and their functionality after the first and third cycles of treatment — Baseline vs Cycle 1 and 3
The quantitative and qualitative pharmacodynamic effects of Ceplene/IL-2 on the immune responses of T and NK cells will be assessed as follows: 1. Changes in T and NK cell phenotypes (CD56, CD3, CD4, CD8) in peripheral blood from Day 1 (baseline) to Day 21‡ of Cycle 1 and from Day 1 (pre-treatment Cycle 3) to Day 21‡ of Cycle 3. 2. Changes in immune response markers (CD3, NKp46 \[and other NCRs\], CD25, CD69, and IFN-γ) in peripheral blood from Day 1 (baseline) to Day 21‡ of Cycle 1 and from Day 1 (pre-treatment Cycle 3) to Day 21‡ of Cycle 3

Countries

Sweden