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Maintenance Therapy With Histamine Dihydrochloride and Interleukin-2 in Adult Acute Myeloid Leukemia (AML) Patients With Measurable Minimal Residual Disease (MRD)- a Non-interventional Study (NIS)

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ClinicalTrials.gov Identifier: NCT01770158
Recruitment Status : Unknown
Verified January 2013 by Jochen Greiner, University of Ulm.
Recruitment status was:  Recruiting
First Posted : January 17, 2013
Last Update Posted : January 17, 2013
Information provided by (Responsible Party):
Jochen Greiner, University of Ulm

Brief Summary:
This is a non-interventional multi-center study (NIS) in adult patients with AML in first complete remission with measurable minimal residual disease (MRD). Patients are eligible when gene status was already determined for previous induction and consolidation therapy of AML and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation. The study objective is to observe the impact of pre-emptive therapy with histamine dihydrochloride (HDC) and interleukin-2 (IL-2) with regard to assess leukemia-free survival/time to relapse and to monitor MRD level trend over time. HDC and IL-2 are approved drugs for AML patients in first complete remission. Therapy is administered for 10 treatment cycles as outlined in the Summary of Product Characteristics.

Condition or disease
Acute Myeloid Leukemia

Study Type : Observational
Estimated Enrollment : 60 participants
Time Perspective: Prospective
Official Title: Maintenance Therapy With Histamine Dihydrochloride and Interleukin-2 in Adult Acute Myeloid Leukemia (AML) Patients With Measurable Minimal Residual Disease (MRD)- a Non-interventional Study (NIS)
Study Start Date : October 2012
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Primary Outcome Measures :
  1. leukemia-free survival / cumulative incidence of relapse [ Time Frame: two years ]

Secondary Outcome Measures :
  1. Toxicity induced by the preemptive treatment with Ceplene and IL-2 [ Time Frame: 18 months ]
    Duration of neutropenia and leukopenia after each treatment cycle, incidence of infections, duration of hospitalization

  2. Overall survival [ Time Frame: two years ]

Other Outcome Measures:
  1. Assessment of quality of life [ Time Frame: two years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with acute myeloid leukaemia (AML) in first remission following completion of consolidation therapy and concomitantly treated with interleukin-2 (IL-2) which will receive treatment with CEPLENE® for the first time. Patients are eligible when gene status was already determined for previous induction and consolidation therapy of AML and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation.

Patient eligibility criteria in accordance to the summary of Product Characteristics:

  • Patients with confirmed diagnosis of acute myeloid leukemia according to the World Health Organization (WHO) classification (including de novo AML, t-AML and s-AML) in first complete remission (defined as less than 5% blasts in a normocellular bone marrow assessed prior to the treatment start)
  • AMLSG BiO participation incl. favourable opinion
  • Presence of NPM1 mutation, CBFB-MYH11 or MLL-AF9 fusion genes as assessed in one of the central AMLSG reference laboratories.
  • Measurable MRD values (non-negative values after consolidation therapy or increase in values over the threshold during follow-up in complete remission)
  • The patient must be informed of the observation and written informed consent regarding data privacy obtained.
  • Consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and all other treating physicians about observation participation
  • No continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770158

Contact: Jochen Greiner, MD 0049-(0)731-5000 jochen.greiner@uniklinik-ulm.de
Contact: Lars Bullinger, MD 049-(0)731-5000 lars.bullinger@uniklinik-ulm.de

Vivantes Hospital Neukölln Recruiting
Berlin, Germany, 12351
Contact: Maike de Wit, MD    0049-(030)-130-142251    maike.dewit@vivantes.de   
Charite, University Medical School of Berlin Recruiting
Berlin, Germany, 13353
Contact: Jörg Westermann, MD    0049-(0)30 450 553 141    joerg.westermann@charite.de   
Darmstadt Clinic Recruiting
Darmstadt, Germany, 64283
Contact: Helga Bernhard, MD    0049-(0)6151-1076650    med5@klinikum-darmstadt.de   
University Hospital of Düsseldorf Recruiting
Düsseldorf, Germany, 40225
Contact: Ulrich Germing, MD    0049-(0)211-81 177 20    germing@med.uni-duesseldorf.de   
Malteser Krankenhaus St. Franziskus Hospital Recruiting
Flensburg, Germany, 24939
Contact: Nadezda Basara, MD    0049-(0)461-816-2512    nadezda.basara@malteser.org   
University of Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Michael Lübbert, MD    0049-(0)761-270-35340    michael.luebbert@uniklinik-freiburg.de   
Wilhelm-Anton-Hospital gGmbH Goch Recruiting
Goch, Germany, 47674
Contact: Volker Runde, MD    0049-(0)2823-891-447    Elke.Beeker-Cornelissen@wah.kkikk.de   
Klinikum Region Hannover GmbH, Krankenhaus Siloah Recruiting
Hannover, Germany, 30449
Contact: Hartmut Kirchner, MD    0049-(0)511-9272801    hartmut.kirchner@krh.eu   
Hannover Medical School Recruiting
Hannover, Germany, 30625
Contact: Jürgen Krauter, MD    0049-(0)511-532-3720    krauter.juergen@mh-hannover.de   
Saarland University Medical Center Recruiting
Homburg/Saar, Germany, 66421
Contact: Michael Pfreundschuh, MD    0049-(0)6841-162-3003    michael.pfreundschuh@uks.eu   
Städtisches Klinikum Karlsruhe gGmbH Recruiting
Karlsruhe, Germany, 76133
Contact: Mark Ringhoffer, MD    0049-(0)721-974 3007    mark.ringhoffer@klinikum-karlsruhe.de   
University Medical Center Schleswig Holstein Recruiting
Kiel, Germany, 24116
Contact: Heinz A Horst, MD    0049-(0)431-1697 1207    h.horst@med2.uni-kiel.de   
Caritas-Krankenhaus Lebach Recruiting
Lebach, Germany, 66822
Contact: Stephan Kremers, MD    0049-(0)6881-501-0    stephankremers@onkologie-lebach.de   
Hospital of Lüdenscheid Recruiting
Lüdenscheid, Germany, 58515
Contact: Gerhard Heil, MD    0049-(0)2351-46-3541    gerhard.heil@klinikum-luedenscheid.de   
University Clinic Magdeburg Recruiting
Magdeburg, Germany, 39120
Contact: Florian Heidel, MD    0049-(0)391-67 13898    florian.heidel@med.ovgu.de   
Hospital of Schwäbisch Gmünd Recruiting
Mutlangen, Germany, 73557
Contact: Holger Hebart, MD    0049-(0)7171-701 1302    holger.hebart@stauferklinikum.de   
University Hospital rechts der Isar Recruiting
München, Germany, 81675
Contact: Katharina Götze, MD    0049-(0)89-4140 5618    k.goetze@lrz.tu-muenchen.de   
Hospital of Passau Recruiting
Passau, Germany, 94032
Contact: Thomas Südhoff, MD    0049-(0)0851-5300-2356    Thomas.suedhoff@klinikum-passau.de   
Hospital of Traunstein Recruiting
Traunstein, Germany, 83278
Contact: Thomas Kubin, MD    0049-(0)861-705-1243    thomas.kubin@klinikum-traunstein.de   
Klinikum Mutterhaus der Borromäerinnen Recruiting
Trier, Germany, 54290
Contact: Rolf Mahlberg, MD    0049-(0)651-9472571    mahlberg@mutterhaus.de   
University Hospital of Ulm Recruiting
Ulm, Germany, 89520
Contact: Jochen Greiner, MD    0049-(0)731-5000    jochen.greiner@uniklinik-ulm.de   
Helios Klinikum Wuppertal Recruiting
Wuppertal, Germany, 42283
Contact: Silke Schostok, MD    0049-(0)202-8963338    silke.schostok@helios-klinikum.de   
Sponsors and Collaborators
University of Ulm
Principal Investigator: Jochen Greiner, MD University Hospital of Ulm

Responsible Party: Jochen Greiner, Prof. Dr. Jochen Greiner, University of Ulm
ClinicalTrials.gov Identifier: NCT01770158     History of Changes
Other Study ID Numbers: AMLSG18-12
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

Keywords provided by Jochen Greiner, University of Ulm:
Acute myeloid leukemia (AML)
Histamine Dihydrochloride

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Histamine phosphate
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action