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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. (see Contacts and Locations)
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

October 9, 2012
January 14, 2013
October 2012
March 2016   (final data collection date for primary outcome measure)
leukemia-free survival / cumulative incidence of relapse [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01770158 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Assessment of quality of life [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
 
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)
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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Acute Myeloid Leukemia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2016
March 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
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
Germany
 
NCT01770158
AMLSG18-12
No
Jochen Greiner, University of Ulm
University of Ulm
Not Provided
Principal Investigator: Jochen Greiner, MD University Hospital of Ulm
University of Ulm
January 2013

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