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Recruiting NCT07627568

Analysis of Biomarkers in Patients With Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation Treated With Menin Inhibition.

Observational Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The white blood cells of patients with acute myeloid leukemia that have undergone allogeneic stem cell transplantation will be investigated. These are patient where the leukemia has returned after the transplantation.

Detailed description

The study will investigate biomarkers including humen endogenous retrovirus expression and T cell phenotypic analysis in patients with AML with NPM1 mutations or KMT2A rearrangements. These biomarkers have been previously described: Blood. 2026 Jan 29;147(5):584-601. doi: 10.1182/blood.2025029712. PMID: 41144759

Primary outcome measures

  • Correlative biomarker [Time frame: 1 year]
  • Biomarkers will be correlated with survival and leukemia response [Time frame: may 2026 till may 2027]

Eligibility criteria

Inclusion criteria

  • Diagnosis of acute myeloid leukemia with NPM1 mutations or KMT2A rearrangements
  • Hematological relapse after allo-HCT
  • 18 years or older

Exclusion criteria

  • no signed informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • University of Freiburg Mdical Center — Freiburg im Breisgau

Publications

  • Uhl FM, Chen S, O'Sullivan D, Edwards-Hicks J, Richter G, Haring E, Andrieux G, Halbach S, Apostolova P, Buscher J, Duquesne S, Melchinger W, Sauer B, Shoumariyeh K, Schmitt-Graeff A, Kreutz M, Lubbert M, Duyster J, Brummer T, Boerries M, Madl T, Blazar BR, Gross O, Pearce EL, Zeiser R. Metabolic reprogramming of donor T cells enhances graft-versus-leukemia effects in mice and humans. Sci Transl M PMID 33115954
  • Mathew NR, Baumgartner F, Braun L, O'Sullivan D, Thomas S, Waterhouse M, Muller TA, Hanke K, Taromi S, Apostolova P, Illert AL, Melchinger W, Duquesne S, Schmitt-Graeff A, Osswald L, Yan KL, Weber A, Tugues S, Spath S, Pfeifer D, Follo M, Claus R, Lubbert M, Rummelt C, Bertz H, Wasch R, Haag J, Schmidts A, Schultheiss M, Bettinger D, Thimme R, Ullrich E, Tanriver Y, Vuong GL, Arnold R, Hemmati P, PMID 29431743
  • Fetsch V, Schwobel L, Ozyerli-Goknar E, Stell AV, Punta M, Plenge T, Klaus T, Gupta MK, Andrieux G, Shoumariyeh K, Pfeiffer S, Corrales E, Schlenke L, Baniadam H, Brandl SM, Andreis M, Remen M, Hartmann A, Grueter K, Zwick M, Kohler N, Kuban M, Metzger E, Rummelt C, Duyster J, Boerries M, Hofmann M, Farber J, Braun LM, Zahringer A, Lubbert M, Toffalori C, Vago L, Heidel FH, Minguet S, Apostolova P PMID 41144759

Identifiers

NCT: NCT07627568 · 30052026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗