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)

Acute Myeloid Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01770158
• Other study ID #: AMLSG18-12
• Status: Terminated
• First received: October 9, 2012
• Last updated: April 5, 2018
• Start date: October 2012
• Est. completion date: March 27, 2018

Study information

• Verified date: April 2018
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 27, 2018
• Est. primary completion date: March 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Neoplasm, Residual

Locations

Country	Name	City	State
Germany	Charite, University Medical School of Berlin	Berlin
Germany	Vivantes Hospital Neukölln	Berlin
Germany	Darmstadt Clinic	Darmstadt
Germany	University Hospital of Düsseldorf	Düsseldorf
Germany	Malteser Krankenhaus St. Franziskus Hospital	Flensburg
Germany	University of Freiburg	Freiburg
Germany	Wilhelm-Anton-Hospital gGmbH Goch	Goch
Germany	Hannover Medical School	Hannover
Germany	Klinikum Region Hannover GmbH, Krankenhaus Siloah	Hannover
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	University Hospital rechts der Isar	München
Germany	Hospital of Schwäbisch Gmünd	Mutlangen
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

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of quality of life		two years
Primary	leukemia-free survival / cumulative incidence of relapse		two years
Secondary	Toxicity induced by the preemptive treatment with Ceplene and IL-2	Duration of neutropenia and leukopenia after each treatment cycle, incidence of infections, duration of hospitalization	18 months
Secondary	Overall survival		two years