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)

NCT ID: NCT01770158

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2018-03-27

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Jochen Greiner

Prof. Dr. Jochen Greiner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jochen Greiner, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Ulm

Locations

Vivantes Hospital Neukölln

Berlin, , Germany

Charite, University Medical School of Berlin

Berlin, , Germany

Darmstadt Clinic

Darmstadt, , Germany

University Hospital of Düsseldorf

Düsseldorf, , Germany

Malteser Krankenhaus St. Franziskus Hospital

Flensburg, , Germany

University of Freiburg

Freiburg im Breisgau, , Germany

Wilhelm-Anton-Hospital gGmbH Goch

Goch, , Germany

Klinikum Region Hannover GmbH, Krankenhaus Siloah

Hanover, , Germany

Hannover Medical School

Hanover, , Germany

Saarland University Medical Center

Homburg/Saar, , Germany

Städtisches Klinikum Karlsruhe gGmbH

Karlsruhe, , Germany

University Medical Center Schleswig Holstein

Kiel, , Germany

Caritas-Krankenhaus Lebach

Lebach, , Germany

Hospital of Lüdenscheid

Lüdenscheid, , Germany

University Clinic Magdeburg

Magdeburg, , Germany

Hospital of Schwäbisch Gmünd

Mutlangen, , Germany

University Hospital rechts der Isar

München, , Germany

Hospital of Passau

Passau, , Germany

Hospital of Traunstein

Traunstein, , Germany

Klinikum Mutterhaus der Borromäerinnen

Trier, , Germany

University Hospital of Ulm

Ulm, , Germany

Helios Klinikum Wuppertal

Wuppertal, , Germany

Countries

Germany

Other Identifiers

AMLSG18-12

Identifier Type: -

Identifier Source: org_study_id