Acute Myeloid Leukemia, AdultNCT05988047
Analysis of CMTM6 Expression in Patients With Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia, Adult, run by University of Freiburg at 1 site in Germany.
Trial summary
In this study, we aim to investigate the expression of CKLF like MARVEL transmembrane domain containing 6 (CMTM6) in leukemia cells of patients with acute myeloid leukemia (AML). We will use peripheral blood samples and assess CMTM6 expression by flow cytometry and Western Blot. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Myeloid Leukemia, Adult
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2020to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Adult, Older adult
Study population: Patients with AML at primary diagnosis ≥ 18 years of age or healthy probands ≥ 18 years of age
Who may be able to join
- age ≥ 18 years
- primary diagnosis of acute myeloid leukemia
- diagnosis results available
- written informed consent
- ability to understand the nature of the study and the study related procedures and to comply with them
Who cannot join
- age < 18 years
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical Center- University of Freiburg
Freiburg im Breisgau, CA, 79106
About this study
In this study, we aim to investigate the expression of CKLF like MARVEL transmembrane domain containing 6 (CMTM6) in leukemia cells of patients with acute myeloid leukemia (AML). We will use peripheral blood samples and assess CMTM6 expression by flow cytometry and Western Blot.
- Conditions
- Acute Myeloid Leukemia, Adult
- 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 |
|---|---|---|
| Patients with AML | Peripheral blood will be taken at the timepoint of primary diagnosis and analyzed for CMTM6 expression and T cell activation | |
| Healthy controls | Peripheral blood will be taken analyzed for CMTM6 expression and T cell activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMTM6 expression (FC)
CMTM6 expression on blasts/monocytes will be measured by flow cytometry
Measured: At primary diagnosis
T cell activation (FC)
T cell activation and cytokine production will be measured by flow cytometry
Measured: At primary diagnosis
Secondary outcomes (1)
CMTM6 expression (WB)
CMTM6 expression on blasts/monocytes will be measured by Western blot
Measured: At primary diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 May 2020
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukemia, AdultStudies 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
- 150 participants (actual)
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
- NCT05988047
- Sponsor's protocol ID
- CMTM6_AML
- Status last verified
- May 2024
- First submitted
- 4 Aug 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zwick M, Zinkel B, Spohr C, Ruckert T, Halbach S, Shoumariyeh K, Scheid J, Baur AS, Braun LM, Angel M, Michaeli E, Todkar A, Nelde A, Marklin M, Holzmayer SJ, Dicks S, Boerries M, Duquesne S, Schlaak AE, Otto-Mora P, Bengsch B, Schiff M, Kissel S, Selle M, Follo M, Altmann H, Kunadt D, Illert AL, Walz JS, Walz G, Duyster J, Schetelig J, Brummer T, Zeiser R, Kohler N. FLT3-ITD Induces CMTM6 and Enhances Immune Escape in Acute Myeloid Leukemia. Cancer Res. 2026 Jan 16;86(2):367-386. doi: 10.1158/0008-5472.CAN-25-0349.
PubMed 41043134
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of CMTM6 Expression in Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05988047
- Acronym / sponsor ID
- CMTM6_AML
- Conditions
- Acute Myeloid Leukemia, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of FreiburgUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 14 Aug 2023 (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.
In this study, we aim to investigate the expression of CKLF like MARVEL transmembrane domain containing 6 (CMTM6) in leukemia cells of patients with acute myeloid leukemia (AML). We will use peripheral blood samples and assess CMTM6 expression by flow cytometry and Western Blot.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with AML | – | –Peripheral blood will be taken at the timepoint of primary diagnosis and analyzed for CMTM6 expression and T cell activation |
| Healthy controls | – | –Peripheral blood will be taken analyzed for CMTM6 expression and T cell activation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with AML at primary diagnosis ≥ 18 years of age or healthy probands ≥ 18 years of age
Key inclusion criteria (5 listed)
- age ≥ 18 years
- primary diagnosis of acute myeloid leukemia
- diagnosis results available
- written informed consent
- ability to understand the nature of the study and the study related procedures and to comply with them
Key exclusion criteria (2 listed)
- age < 18 years
- lack of 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
CMTM6 expression (FC)
Time frame: At primary diagnosis
CMTM6 expression on blasts/monocytes will be measured by flow cytometry
T cell activation (FC)
Time frame: At primary diagnosis
T cell activation and cytokine production will be measured by flow cytometry
1 secondary outcome
CMTM6 expression (WB)
Time frame: At primary diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 41043134Zwick M, Zinkel B, Spohr C, Ruckert T, Halbach S, Shoumariyeh K, Scheid J, Baur AS, Braun LM, Angel M, Michaeli E, Todkar A, Nelde A, Marklin M, Holzmayer SJ, Dicks S, Boerries M, Duquesne S, Schlaak AE, Otto-Mora P, Bengsch B, Schiff M, Kissel S, Selle M, Follo M, Altmann H, Kunadt D, Illert AL, Walz JS, Walz G, Duyster J, Schetelig J, Brummer T, Zeiser R, Kohler N. FLT3-ITD Induces CMTM6 and Enhances Immune Escape in Acute Myeloid Leukemia. Cancer Res. 2026 Jan 16;86(2):367-386. doi: 10.1158/0008-5472.CAN-25-0349.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, Adult, 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 8 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMTM6 expression (FC) (time frame: At primary diagnosis). 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 NCT05988047, which also lists 1 linked publication.
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 8 May 2024.