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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)

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)

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01770158
Enrollment
8
Registered
2013-01-17
Start date
2012-10-31
Completion date
2018-03-27
Last updated
2018-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemia (AML), Histamine Dihydrochloride, Interleukin-2

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.

Interventions

None listed

Sponsors

University of Ulm
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
leukemia-free survival / cumulative incidence of relapsetwo years

Secondary

MeasureTime frameDescription
Toxicity induced by the preemptive treatment with Ceplene and IL-218 monthsDuration of neutropenia and leukopenia after each treatment cycle, incidence of infections, duration of hospitalization
Overall survivaltwo years

Other

MeasureTime frame
Assessment of quality of lifetwo years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026