Myeloid MalignancyMyeloGenNCT07112287
Germline Testing for Predisposition to Myeloid Malignancies
A study testing MyeloGen Gene Panel in people with Myeloid Malignancy and Genetic Predisposition to Disease, run by Christopher Reilly at 1 site in United States.
Trial summary
The goal of this research study is to evaluate the feasibility of germline genetic testing using the investigational MyeloGen Gene Panel in adult participants diagnosed with myeloid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Malignancy, Genetic Predisposition to Disease, Myeloid Hematological Malignancies
- What is being tested?
- MyeloGen Gene Panel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2025to 1 Apr 2033
- Phase
- Interventional
- 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
Who may be able to join
- Age of 18 years or older
- Participants must have histologically confirmed myeloid malignancy OR bone marrow failure within the last 6 months prior to screening.
- Ability to understand and provide a signed and completed consent document in English.
Who cannot join
- Participants who cannot safely undergo clinically indicated skin biopsy as adjudicated by the study team.
- Participants who have previously undergone germline genetic testing for predisposition to myeloid malignancies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Christopher R Reilly, MD, 407-443-6243, christopherr_reilly@dfci.harvard.edu
Christopher R Reilly, MD
About this study
Official title: MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies
The goal of this research study is to evaluate the feasibility of germline genetic testing using the investigational MyeloGen Gene Panel in adult participants diagnosed with myeloid malignancies.
Read the detailed description
This prospective, single arm study aims to evaluate the feasibility of germline genetic testing using the investigational MyeloGen Gene Panel in adult participants diagnosed with myeloid malignancies. Investigators hope to learn how to best incorporate routine genetic testing in clinical care for participants with blood cancers, regardless of personal or family history of blood cancer.
The research study procedures include screening for eligibility, in-clinic visits, questionnaires, and punch skin biopsies.
It is expected that about 200 people will take part in this research study.
The laboratory sponsor of this protocol is Broad Clinical Laboratory.
- Being tested
- MyeloGen Gene Panel
- Keywords
- Myeloid Malignancies, Genetic Predisposition to Disease
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyeloGen Gene PanelDevice
Also called Custom hereditary cancer gene panel
The MyeloGen Gene Panel is investigational Germline genetic testing using skin fibroblasts.
| Study group | Role | What they receive |
|---|---|---|
| MyeloGen Germline Testing Group | Experimental | Enrolled participants will complete:
* Baseline visit with questionnaires, educational video, and punch skin biopsy
* Negative genetic test results notification via mail
* Positive genetic results will be followed up by an appointment with a genetic counselor or physician
* Post-results questionnaires
* Follow up via medical records for up to 2 years from time of study consent. Receives: Device: MyeloGen Gene Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Completion Rate
Successful completion rate of germline genetic testing will be defined as the proportion of participants who return genetic test results within 10 weeks of study consent, which would require there be no excessive delays in obtaining a skin biopsy.
Measured: Up to 10 weeks
Secondary outcomes (3)
Number of Participants with Positive Results
A "positive" result indicating a pathogenic or likely pathogenic variant was detected. This will also include Variants of Unknown Significance (VUSs) with supporting pathogenic criteria per American College of Medical Genetics guidelines (ACMG).
Measured: Up to 12 weeks
Patient Reported Outcome of Germline Genetic Testing based on GST Survey
Participants will complete the GST survey 1 (after the educational video and skin biopsy) and GST survey 2 between 45-60 days after disclosure of genetic test results. GST survey answers will be converted to a 5-point scale: 1- Disagree strongly, 2-Disagree, 3-Neither Agree or Disagree, 4-Agree, 5- Agree strongly.
Measured: Up to 60 days
Number of Participants with an Identified Germline Predisposition on Generic Testing Who Haven't Met NCNN Guideline-based Germline Genetic Testing Recommendations
NCCN guideline-based eligibility for germline genetic testing will be assessed using the following criteria and manual review of participants' medical record, 1) Participants with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) less than age 50, 2) Hypoplastic MDS regardless of age; 3) History of aplastic anemia, 4) Documented suspicion of a possible germline predisposition to myeloid malignancies.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start10 Nov 2025
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid MalignancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher Reilly
- Sponsor type
- University, hospital or other
- Collaborators
- Broad Institute of MIT and Harvard
- Responsible party
- Sponsor-investigator, Christopher Reilly, Dana-Farber Cancer Institute
- Investigators
- Christopher R Reilly, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112287
- Sponsor's protocol ID
- 25-218
- Acronym
- MyeloGen
- Status last verified
- Apr 2026
- First submitted
- 1 Aug 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies
- ClinicalTrials.gov ID
- NCT07112287
- Acronym / sponsor ID
- MyeloGen / 25-218
- Keywords
- Myeloid Malignancies, Genetic Predisposition to Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Christopher ReillyUniversity, hospital or other
- Collaborators
- Broad Institute of MIT and Harvard
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2033 (estimated)
- First posted
- 8 Aug 2025 (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 goal of this research study is to evaluate the feasibility of germline genetic testing using the investigational MyeloGen Gene Panel in adult participants diagnosed with myeloid malignancies.
Detailed description
This prospective, single arm study aims to evaluate the feasibility of germline genetic testing using the investigational MyeloGen Gene Panel in adult participants diagnosed with myeloid malignancies. Investigators hope to learn how to best incorporate routine genetic testing in clinical care for participants with blood cancers, regardless of personal or family history of blood cancer.
The research study procedures include screening for eligibility, in-clinic visits, questionnaires, and punch skin biopsies.
It is expected that about 200 people will take part in this research study.
The laboratory sponsor of this protocol is Broad Clinical Laboratory.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyeloGen Germline Testing Group | Experimental | Device: MyeloGen Gene PanelEnrolled participants will complete: * Baseline visit with questionnaires, educational video, and punch skin biopsy * Negative genetic test results notification via mail * Positive genetic results will be followed up by an appointment with a genetic counselor or physician * Post-results questionnaires * Follow up via medical records for up to 2 years from time of study consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 18 years or older
- Participants must have histologically confirmed myeloid malignancy OR bone marrow failure within the last 6 months prior to screening.
- Ability to understand and provide a signed and completed consent document in English.
Key exclusion criteria (2 listed)
- Participants who cannot safely undergo clinically indicated skin biopsy as adjudicated by the study team.
- Participants who have previously undergone germline genetic testing for predisposition to myeloid malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyeloGen Gene PanelAlso: Custom hereditary cancer gene panelThe MyeloGen Gene Panel is investigational Germline genetic testing using skin fibroblasts. | Device | MyeloGen Germline Testing Group |
Primary outcome
Successful Completion Rate
Time frame: Up to 10 weeks
Successful completion rate of germline genetic testing will be defined as the proportion of participants who return genetic test results within 10 weeks of study consent, which would require there be no excessive delays in obtaining a skin biopsy.
3 secondary outcomes
Number of Participants with Positive Results
Time frame: Up to 12 weeks
Patient Reported Outcome of Germline Genetic Testing based on GST Survey
Time frame: Up to 60 days
Number of Participants with an Identified Germline Predisposition on Generic Testing Who Haven't Met NCNN Guideline-based Germline Genetic Testing Recommendations
Time frame: Up to 12 weeks
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 24 Apr 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Christopher R Reilly, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyeloGen Gene Panel in people with Myeloid Malignancy and Genetic Predisposition to Disease, run by Christopher Reilly at 1 site in United States.
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 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: looking for participants now, as of the sponsor's last update on 24 Apr 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 United States. 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 Christopher R Reilly, MD (407-443-6243, Christopherr_reilly@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Completion Rate (time frame: Up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.