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)
This study is currently recruiting participants.
Verified January 2013 by University of Ulm
Sponsor:
University of Ulm
Information provided by (Responsible Party):
Jochen Greiner, University of Ulm
ClinicalTrials.gov Identifier:
NCT01770158
First received: October 9, 2012
Last updated: January 14, 2013
Last verified: January 2013
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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:
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
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 | |
| 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 | |
| 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, Acute Leukemia, Myeloid Neoplasm, Residual Neoplasms by Histologic Type Neoplasms Neoplastic Processes Pathologic Processes Histamine Histamine phosphate Interleukin-2 Histamine Agonists |
Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antineoplastic Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013