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)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Jochen Greiner, University of Ulm.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University of Ulm
ClinicalTrials.gov Identifier:
NCT01770158
First Posted: January 17, 2013
Last Update Posted: January 17, 2013
Information provided by (Responsible Party):
Jochen Greiner, University of Ulm
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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
Genetic and Rare Diseases Information Center resources:
Myeloid Leukemia
Acute Myeloid Leukemia
Acute Non Lymphoblastic Leukemia
U.S. FDA Resources
Further study details as provided by Jochen Greiner, University of Ulm:
Primary Outcome Measures:
- leukemia-free survival / cumulative incidence of relapse [ Time Frame: two years ]
Secondary Outcome Measures:
- 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
- Overall survival [ Time Frame: two years ]
Other Outcome Measures:
- Assessment of quality of life [ Time Frame: two years ]
| 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
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.
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
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
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 | |
| 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
Investigators
| Principal Investigator: | Jochen Greiner, MD | University Hospital of Ulm |
More Information
| 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 Submitted: | October 9, 2012 |
| First Posted: | January 17, 2013 |
| Last Update Posted: | January 17, 2013 |
| Last Verified: | January 2013 |
Keywords provided by Jochen Greiner, University of Ulm:
|
Acute myeloid leukemia (AML) Histamine Dihydrochloride Interleukin-2 |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasm, Residual Neoplasms by Histologic Type Neoplasms Neoplastic Processes Pathologic Processes Interleukin-2 Histamine Histamine phosphate |
Antineoplastic Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Histamine Agonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |