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)
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NCT01770158
- Lead Sponsor
- University of Ulm
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method leukemia-free survival / cumulative incidence of relapse two years
- Secondary Outcome Measures
Name Time Method Overall survival two years Toxicity induced by the preemptive treatment with Ceplene and IL-2 18 months Duration of neutropenia and leukopenia after each treatment cycle, incidence of infections, duration of hospitalization
Trial Locations
- Locations (22)
University Hospital of Ulm
🇩🇪Ulm, Germany
Hannover Medical School
🇩🇪Hannover, Germany
University Hospital rechts der Isar
🇩🇪München, Germany
Hospital of Passau
🇩🇪Passau, Germany
Hospital of Traunstein
🇩🇪Traunstein, Germany
Klinikum Mutterhaus der Borromäerinnen
🇩🇪Trier, Germany
Wilhelm-Anton-Hospital gGmbH Goch
🇩🇪Goch, Germany
Klinikum Region Hannover GmbH, Krankenhaus Siloah
🇩🇪Hannover, Germany
Städtisches Klinikum Karlsruhe gGmbH
🇩🇪Karlsruhe, Germany
Darmstadt Clinic
🇩🇪Darmstadt, Germany
Saarland University Medical Center
🇩🇪Homburg/Saar, Germany
Hospital of Lüdenscheid
🇩🇪Lüdenscheid, Germany
University Clinic Magdeburg
🇩🇪Magdeburg, Germany
University of Freiburg
🇩🇪Freiburg, Germany
Caritas-Krankenhaus Lebach
🇩🇪Lebach, Germany
Hospital of Schwäbisch Gmünd
🇩🇪Mutlangen, Germany
Helios Klinikum Wuppertal
🇩🇪Wuppertal, Germany
Vivantes Hospital Neukölln
🇩🇪Berlin, Germany
Charite, University Medical School of Berlin
🇩🇪Berlin, Germany
University Hospital of Düsseldorf
🇩🇪Düsseldorf, Germany
Malteser Krankenhaus St. Franziskus Hospital
🇩🇪Flensburg, Germany
University Medical Center Schleswig Holstein
🇩🇪Kiel, Germany