Acute Myeloid LeukemiaAML_MenALLONCT07627568
Analysis of Biomarkers in Patients With Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation Treated With Menin Inhibition.
An observational study of Acute Myeloid Leukemia, run by University of Freiburg at 1 site in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 30 May 2026to 30 May 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AML with NPM1 mutations or KMT2A rearrangements that experience a hematological relapse after allo-HCT
Who may be able to join
- Diagnosis of acute myeloid leukemia with NPM1 mutations or KMT2A rearrangements
- Hematological relapse after allo-HCT
- 18 years or older
Who cannot join
- no signed informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University of Freiburg Mdical Center
Freiburg im Breisgau, 79106
ECTU, +4976127034020, robert.zeiser@uniklinik-freiburg.de
About this study
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
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myeloid leukemia, alloegeneic stem cell transplantation, menin inhibitor
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Correlative biomarker
HERV expression by AML cells
Measured: 1 year
Biomarkers will be correlated with survival and leukemia response
The biomarkers HERV, HLA class I and II, T cell phenotype
Measured: may 2026 till may 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start30 May 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Zeiser, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627568
- Sponsor's protocol ID
- 30052026
- Acronym
- AML_MenALLO
- Status last verified
- May 2026
- First submitted
- 30 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 33115954Mathew 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 29431743Fetsch 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Biomarkers in Patients With Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation Treated With Menin Inhibition.
- ClinicalTrials.gov ID
- NCT07627568
- Acronym / sponsor ID
- AML_MenALLO / 30052026
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myeloid leukemia, alloegeneic stem cell transplantation, menin inhibitor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of FreiburgUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AML with NPM1 mutations or KMT2A rearrangements that experience a hematological relapse after allo-HCT
Key inclusion criteria (3 listed)
- Diagnosis of acute myeloid leukemia with NPM1 mutations or KMT2A rearrangements
- Hematological relapse after allo-HCT
- 18 years or older
Key exclusion criteria (1 listed)
- no signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlative biomarker
Time frame: 1 year
HERV expression by AML cells
Biomarkers will be correlated with survival and leukemia response
Time frame: may 2026 till may 2027
The biomarkers HERV, HLA class I and II, T cell phenotype
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 33115954Uhl 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.
- Background: PubMed 29431743Mathew 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.
- Background: PubMed 41144759Fetsch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by University of Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Zeiser, MD (+4976127034020, robert.zeiser@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlative biomarker (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07627568, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.