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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)

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ClinicalTrials.gov Identifier: NCT01770158
Recruitment Status : Terminated (Recruitment goal cannot be achieved any more as only 8 patients have been recruited since start of the study in 2012.)
First Posted : January 17, 2013
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Jochen Greiner, University of Ulm

Study Description
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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.

Condition or disease
Acute Myeloid Leukemia

Study Design
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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Other
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)
Study Start Date : October 2012
Actual Primary Completion Date : March 27, 2018
Actual Study Completion Date : March 27, 2018

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. leukemia-free survival / cumulative incidence of relapse [ Time Frame: two years ]

Secondary Outcome Measures :
  1. 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

  2. Overall survival [ Time Frame: two years ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770158


Locations
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Sponsors and Collaborators
University of Ulm
Investigators
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Principal Investigator: Jochen Greiner, MD University Hospital of Ulm
More Information
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Responsible Party: Jochen Greiner, Prof. Dr. Jochen Greiner, University of Ulm
ClinicalTrials.gov Identifier: NCT01770158    
Other Study ID Numbers: AMLSG18-12
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Keywords provided by Jochen Greiner, University of Ulm:
Acute myeloid leukemia (AML)
Histamine Dihydrochloride
Interleukin-2
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasm, Residual
 Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes