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

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.

Study Overview

• Status: Recruiting
• Conditions: AML With NPM1 Mutations or KMT2A Rearrangements

Detailed Description

We plan to 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 by us in: Blood. 2026 Jan 29;147(5):584-601. doi: 10.1182/blood.2025029712. PMID: 41144759

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Robert Zeiser, MD; Phone Number: +4976127034020; Email: robert.zeiser@uniklinik-freiburg.de

Study Locations

• Germany
  • Freiburg im Breisgau, Germany, 79106
    • Recruiting
    • University of Freiburg Mdical Center
    • Contact: ECTU; Phone Number: +4976127034020; Email: robert.zeiser@uniklinik-freiburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlative biomarker	HERV expression by AML cells	1 year
Biomarkers will be correlated with survival and leukemia response	The biomarkers HERV, HLA class I and II, T cell phenotype	may 2026 till may 2027

Collaborators and Investigators

• Sponsor: University of Freiburg

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: May 30, 2026
• First Submitted That Met QC Criteria: May 30, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: acute myeloid leukemia, NPM1 mutation, KMT2A rearrangements
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 30052026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No