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)

NCT01770158 | Terminated

• 1 other identifier: AMLSG18-12
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 22

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

Keywords

Acute myeloid leukemia (AML); Histamine Dihydrochloride; Interleukin-2

Outcome Measures

Primary Outcomes (1)

• leukemia-free survival / cumulative incidence of relapse

  two years

Secondary Outcomes (2)

• Toxicity induced by the preemptive treatment with Ceplene and IL-2

  18 months

• Overall survival

  two years

Other Outcomes (1)

• Assessment of quality of life

  two years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (22)

Vivantes Hospital Neukölln

Berlin, 12351, Germany

Location

Charite, University Medical School of Berlin

Berlin, 13353, Germany

Location

Darmstadt Clinic

Darmstadt, 64283, Germany

Location

University Hospital of Düsseldorf

Düsseldorf, 40225, Germany

Location

Malteser Krankenhaus St. Franziskus Hospital

Flensburg, 24939, Germany

Location

University of Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Wilhelm-Anton-Hospital gGmbH Goch

Goch, 47674, Germany

Location

Klinikum Region Hannover GmbH, Krankenhaus Siloah

Hanover, 30449, Germany

Location

Hannover Medical School

Hanover, 30625, Germany

Location

Saarland University Medical Center

Homburg/Saar, 66421, Germany

Location

Städtisches Klinikum Karlsruhe gGmbH

Karlsruhe, 76133, Germany

Location

University Medical Center Schleswig Holstein

Kiel, 24116, Germany

Location

Caritas-Krankenhaus Lebach

Lebach, 66822, Germany

Location

Hospital of Lüdenscheid

Lüdenscheid, 58515, Germany

Location

University Clinic Magdeburg

Magdeburg, 39120, Germany

Location

Hospital of Schwäbisch Gmünd

Mutlangen, 73557, Germany

Location

University Hospital rechts der Isar

München, 81675, Germany

Location

Hospital of Passau

Passau, 94032, Germany

Location

Hospital of Traunstein

Traunstein, 83278, Germany

Location

Klinikum Mutterhaus der Borromäerinnen

Trier, 54290, Germany

Location

University Hospital of Ulm

Ulm, 89520, Germany

Location

Helios Klinikum Wuppertal

Wuppertal, 42283, Germany

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jochen Greiner, MD

  University Hospital of Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Jochen Greiner

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: January 17, 2013
• Study Start: October 1, 2012
• Primary Completion: March 27, 2018
• Study Completion: March 27, 2018
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

DE (22)