Clinical trial NCT01770158: 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)
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid leukemia (AML)
Histamine Dihydrochloride
Interleukin-2
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: leukemia-free survival / cumulative incidence of relapse
timeFrame: two years
Secondary outcomes:
measure: Toxicity induced by the preemptive treatment with Ceplene and IL-2
timeFrame: 18 months
measure: Overall survival
timeFrame: two years
Other outcomes:
measure: Assessment of quality of life
timeFrame: two years
Locations:
city: Berlin
country: Germany
facility: Vivantes Hospital Neukölln
city: Berlin
country: Germany
facility: Charite, University Medical School of Berlin
city: Darmstadt
country: Germany
facility: Darmstadt Clinic
city: Düsseldorf
country: Germany
facility: University Hospital of Düsseldorf
city: Flensburg
country: Germany
facility: Malteser Krankenhaus St. Franziskus Hospital
city: Freiburg
country: Germany
facility: University of Freiburg
city: Goch
country: Germany
facility: Wilhelm-Anton-Hospital gGmbH Goch
city: Hannover
country: Germany
facility: Klinikum Region Hannover GmbH, Krankenhaus Siloah
city: Hannover
country: Germany
facility: Hannover Medical School
city: Homburg/Saar
country: Germany
facility: Saarland University Medical Center
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe gGmbH
city: Kiel
country: Germany
facility: University Medical Center Schleswig Holstein
city: Lebach
country: Germany
facility: Caritas-Krankenhaus Lebach
city: Lüdenscheid
country: Germany
facility: Hospital of Lüdenscheid
city: Magdeburg
country: Germany
facility: University Clinic Magdeburg
city: Mutlangen
country: Germany
facility: Hospital of Schwäbisch Gmünd
city: München
country: Germany
facility: University Hospital rechts der Isar
city: Passau
country: Germany
facility: Hospital of Passau
city: Traunstein
country: Germany
facility: Hospital of Traunstein
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromäerinnen
city: Ulm
country: Germany
facility: University Hospital of Ulm
city: Wuppertal
country: Germany
facility: Helios Klinikum Wuppertal
Study officials:
affiliation: University Hospital of Ulm
name: Jochen Greiner, MD
role: PRINCIPAL_INVESTIGATOR
References: