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) - Full Text View

Purpose

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
Acute Myeloid Leukemia


Study Type:	Observational
Study Design:	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)

Resource links provided by NLM:

Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: Histamine Histamine phosphate Histamine dihydrochloride

Genetic and Rare Diseases Information Center resources: Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Acute Non Lymphoblastic Leukemia Leukemia, Myeloid

U.S. FDA Resources

Further study details as provided by University of Ulm:

Primary Outcome Measures:

leukemia-free survival / cumulative incidence of relapse [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity induced by the preemptive treatment with Ceplene and IL-2 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Duration of neutropenia and leukopenia after each treatment cycle, incidence of infections, duration of hospitalization
Overall survival [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:

Assessment of quality of life [ Time Frame: two years ] [ Designated as safety issue: No ]


Estimated Enrollment:	60
Study Start Date:	October 2012
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770158

Contacts


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

Locations


Germany
Charite, University Medical School of Berlin	Recruiting
Berlin, Germany, 13353
Contact: Jörg Westermann, MD 0049-(0)30 450 553 141 joerg.westermann@charite.de
Vivantes Hospital Neukölln	Recruiting
Berlin, Germany, 12351
Contact: Maike de Wit, MD 0049-(030)-130-142251 maike.dewit@vivantes.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
Hannover Medical School	Recruiting
Hannover, Germany, 30625
Contact: Jürgen Krauter, MD 0049-(0)511-532-3720 krauter.juergen@mh-hannover.de
Klinikum Region Hannover GmbH, Krankenhaus Siloah	Recruiting
Hannover, Germany, 30449
Contact: Hartmut Kirchner, MD 0049-(0)511-9272801 hartmut.kirchner@krh.eu
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

Investigators


Principal Investigator:	Jochen Greiner, MD	University Hospital of Ulm

More Information

No publications provided


Responsible Party:	Jochen Greiner, Prof. Dr. Jochen Greiner, University of Ulm
ClinicalTrials.gov Identifier:	NCT01770158 History of Changes
Other Study ID Numbers:	AMLSG18-12
Study First Received:	October 9, 2012
Last Updated:	January 14, 2013
Health Authority:	Germany: not applicable (non-interventional study)

Keywords provided by University of Ulm:


Acute myeloid leukemia (AML) Histamine Dihydrochloride Interleukin-2

Additional relevant MeSH terms:


Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasm, Residual Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Histamine Histamine phosphate Interleukin-2 Analgesics	Analgesics, Non-Narcotic Antineoplastic Agents Central Nervous System Agents Histamine Agents Histamine Agonists Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015