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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)


N/A
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

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)

Inclusion 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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

leukemia-free survival / cumulative incidence of relapse

Outcome Time Frame:

two years

Safety Issue:

No

Principal Investigator

Jochen Greiner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Ulm

Authority:

Germany: not applicable (non-interventional study)

Study ID:

AMLSG18-12

NCT ID:

NCT01770158

Start Date:

October 2012

Completion Date:

March 2016

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute myeloid leukemia (AML)
  • Histamine Dihydrochloride
  • Interleukin-2
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Neoplasm, Residual

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