Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemia (AML)Histamine DihydrochlorideInterleukin-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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

University of Ulm
Otherlead

Study Sites (22)

Vivantes Hospital Neukölln

Berlin, 12351, Germany

Charite, University Medical School of Berlin

Berlin, 13353, Germany

Darmstadt Clinic

Darmstadt, 64283, Germany

University Hospital of Düsseldorf

Düsseldorf, 40225, Germany

Malteser Krankenhaus St. Franziskus Hospital

Flensburg, 24939, Germany

University of Freiburg

Freiburg im Breisgau, 79106, Germany

Wilhelm-Anton-Hospital gGmbH Goch

Goch, 47674, Germany

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

Jochen Greiner, MD
University Hospital of Ulm
PRINCIPAL INVESTIGATOR

Enrollment

8 participants (actual enrollment reported by the registry).

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 2012

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

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)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Eligibility Criteria

Sponsors & Collaborators

Study Sites (22)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Eligibility Criteria

Sponsors & Collaborators

Study Sites (22)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations