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)

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.

Study Overview

• Status: Terminated
• Conditions: Acute Myeloid Leukemia

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12351
    • Vivantes Hospital Neukölln
  • Berlin, Germany, 13353
    • Charite, University Medical School of Berlin
  • Darmstadt, Germany, 64283
    • Darmstadt Clinic
  • Düsseldorf, Germany, 40225
    • University Hospital of Düsseldorf
  • Flensburg, Germany, 24939
    • Malteser Krankenhaus St. Franziskus Hospital
  • Freiburg, Germany, 79106
    • University of Freiburg
  • Goch, Germany, 47674
    • Wilhelm-Anton-Hospital gGmbH Goch
  • Hannover, Germany, 30625
    • Hannover Medical School
  • Hannover, Germany, 30449
    • Klinikum Region Hannover GmbH, Krankenhaus Siloah
  • Homburg/Saar, Germany, 66421
    • Saarland University Medical Center
  • Karlsruhe, Germany, 76133
    • Städtisches Klinikum Karlsruhe gGmbH
  • Kiel, Germany, 24116
    • University Medical Center Schleswig Holstein
  • Lebach, Germany, 66822
    • Caritas-Krankenhaus Lebach
  • Lüdenscheid, Germany, 58515
    • Hospital of Lüdenscheid
  • Magdeburg, Germany, 39120
    • University Clinic Magdeburg
  • Mutlangen, Germany, 73557
    • Hospital of Schwäbisch Gmünd
  • München, Germany, 81675
    • University Hospital Rechts der Isar
  • Passau, Germany, 94032
    • Hospital of Passau
  • Traunstein, Germany, 83278
    • Hospital of Traunstein
  • Trier, Germany, 54290
    • Klinikum Mutterhaus der Borromaerinnen
  • Ulm, Germany, 89520
    • University Hospital of Ulm
  • Wuppertal, Germany, 42283
    • Helios Klinikum Wuppertal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
leukemia-free survival / cumulative incidence of relapse	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		two years
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

Other Outcome Measures

Outcome Measure	Time Frame
Assessment of quality of life	two years

Collaborators and Investigators

• Sponsor: University of Ulm
• Investigators: Principal Investigator: Jochen Greiner, MD, University Hospital of Ulm

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 27, 2018
• Study Completion (Actual): March 27, 2018

Study Registration Dates

• First Submitted: October 9, 2012
• First Submitted That Met QC Criteria: January 14, 2013
• First Posted (Estimate): January 17, 2013

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Acute myeloid leukemia (AML); Interleukin-2; Histamine Dihydrochloride
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neoplasm, Residual
• Other Study ID Numbers: AMLSG18-12