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

NCT01347996 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2017-11-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

histamine dihydrochloride and IL-2

Ceplene 0.5 mg subcutaneously twice daily and IL-2 1 µg/kg \[16,400 IU/kg\] body weight twice daily for 10, 21 day cycles

Sponsors & Collaborators

  • EpiCept Corporation

    collaborator INDUSTRY

  • Cytovia, Inc.

    lead OTHER

Principal Investigators

  • Robin FOA, MD, PhD · Università degli Studi di Roma "La Sapienza" Dipartimento di Biotecnologie Cellulari ed Ematolgia

  • Mats L Brune, MD, PhD · Sahlgrenska Academy University of Gothenburg, Gothenburg, Sweden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01347996 on ClinicalTrials.gov