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 study is currently recruiting participants.

Verified January 2013 by University of Ulm

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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 9, 2012

Last Updated Date

January 14, 2013

Start Date ^ICMJE

October 2012

Estimated Primary Completion Date

March 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

leukemia-free survival / cumulative incidence of relapse [ Time Frame: two years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01770158 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Toxicity induced by the preemptive treatment with Ceplene and IL-2 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Duration of neutropenia and leukopenia after each treatment cycle, incidence of infections, duration of hospitalization
Overall survival [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Assessment of quality of life [ Time Frame: two years ] [ Designated as safety issue: No ]

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Acute Myeloid Leukemia

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2016

Estimated Primary Completion Date

March 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jochen Greiner, MD	0049-(0)731-5000	jochen.greiner@uniklinik-ulm.de
Contact: Lars Bullinger, MD	049-(0)731-5000	lars.bullinger@uniklinik-ulm.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01770158

Other Study ID Numbers ^ICMJE

AMLSG18-12

Has Data Monitoring Committee

Responsible Party

Jochen Greiner, University of Ulm

Study Sponsor ^ICMJE

University of Ulm

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jochen Greiner, MD

University Hospital of Ulm

Information Provided By

University of Ulm

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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