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RecruitingNCT07627568AML_MenALLOUpdated Jun 10, 2026

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

An observational study in Acute Myeloid Leukemia, sponsored by University of Freiburg. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by University of Freiburg · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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

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Conditions studied

  • Acute Myeloid Leukemia

Keywords

  • acute myeloid leukemia
  • alloegeneic stem cell transplantation
  • menin inhibitor
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In context

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.

This study's planned enrollment of 20 is below the median of 120 across 317 observational studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

University of Freiburg is the lead sponsor of 27 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with AML with NPM1 mutations or KMT2A rearrangements that experience a hematological relapse after allo-HCT

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • no signed informed consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • AML with NPM1 mutations or KMT2A rearrangements

    AML with NPM1 mutations or KMT2A rearrangements that will be treated with immunotherapy (DLI) and immunmodulatory drugs recommended by the guidelines.

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What researchers measure

Primary outcomes

  1. Correlative biomarker

    HERV expression by AML cells

    Time frame: 1 year

  2. Biomarkers will be correlated with survival and leukemia response

    The biomarkers HERV, HLA class I and II, T cell phenotype

    Time frame: may 2026 till may 2027

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Study locations

1 of 1 sites recruiting
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References and documents

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 Med. 2020 Oct 28;12(567):eabb8969. doi: 10.1126/scitranslmed.abb8969. PubMed 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, Wolf D, Ditschkowski M, Jilg C, Wilhelm K, Leiber C, Gerull S, Halter J, Lengerke C, Pabst T, Schroeder T, Kobbe G, Rosler W, Doostkam S, Meckel S, Stabla K, Metzelder SK, Halbach S, Brummer T, Hu Z, Dengjel J, Hackanson B, Schmid C, Holtick U, Scheid C, Spyridonidis A, Stolzel F, Ordemann R, Muller LP, Sicre-de-Fontbrune F, Ihorst G, Kuball J, Ehlert JE, Feger D, Wagner EM, Cahn JY, Schnell J, Kuchenbauer F, Bunjes D, Chakraverty R, Richardson S, Gill S, Kroger N, Ayuk F, Vago L, Ciceri F, Muller AM, Kondo T, Teshima T, Klaeger S, Kuster B, Kim DDH, Weisdorf D, van der Velden W, Dorfel D, Bethge W, Hilgendorf I, Hochhaus A, Andrieux G, Borries M, Busch H, Magenau J, Reddy P, Labopin M, Antin JH, Henden AS, Hill GR, Kennedy GA, Bar M, Sarma A, McLornan D, Mufti G, Oran B, Rezvani K, Shah O, Negrin RS, Nagler A, Prinz M, Burchert A, Neubauer A, Beelen D, Mackensen A, von Bubnoff N, Herr W, Becher B, Socie G, Caligiuri MA, Ruggiero E, Bonini C, Hacker G, Duyster J, Finke J, Pearce E, Blazar BR, Zeiser R. Sorafenib promotes graft-versus-leukemia activity in mice and humans through IL-15 production in FLT3-ITD-mutant leukemia cells. Nat Med. 2018 Mar;24(3):282-291. doi: 10.1038/nm.4484. Epub 2018 Feb 12. PubMed 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, Feuchtinger T, Maas-Bauer K, Blaeschke F, Kuhn MWM, Timmers HTM, Wertheimer T, Perner F, Zeiser R. Menin inhibition enhances graft-versus-leukemia effects by T-cell activation and endogenous retrovirus induction in AML. Blood. 2026 Jan 29;147(5):584-601. doi: 10.1182/blood.2025029712. PubMed 41144759 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07627568
Lead sponsor
University of Freiburg
Responsible party
Robert Zeiser (Professor of Medicine, University of Freiburg) — Principal investigator
First posted
Jun 4, 2026
Start date
May 30, 2026 (estimated)
Primary completion
May 30, 2027 (estimated)
Completion
May 30, 2027 (estimated)
Last update
Jun 10, 2026

Study contacts

Robert Zeiser, MD
Contact
robert.zeiser@uniklinik-freiburg.de
+4976127034020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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