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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by University of Ulm.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jochen Greiner, University of Ulm
ClinicalTrials.gov Identifier:
NCT01770158
First received: October 9, 2012
Last updated: January 14, 2013
Last verified: January 2013
  Purpose
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.

Condition
Acute Myeloid Leukemia

Study Type: Observational
Study Design: Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • leukemia-free survival / cumulative incidence of relapse [ Time Frame: two years ]

Secondary Outcome Measures:
  • Toxicity induced by the preemptive treatment with Ceplene and IL-2 [ Time Frame: 18 months ]
    Duration of neutropenia and leukopenia after each treatment cycle, incidence of infections, duration of hospitalization

  • Overall survival [ Time Frame: two years ]

Other Outcome Measures:
  • Assessment of quality of life [ Time Frame: two years ]

Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770158

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

Responsible Party: Jochen Greiner, Prof. Dr. Jochen Greiner, University of Ulm
ClinicalTrials.gov Identifier: NCT01770158     History of Changes
Other Study ID Numbers: AMLSG18-12 
Study First Received: October 9, 2012
Last Updated: January 14, 2013

Keywords provided by University of Ulm:
Acute myeloid leukemia (AML)
Histamine Dihydrochloride
Interleukin-2

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Histamine
Histamine phosphate
Interleukin-2
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 19, 2017