MyeloGen Gene Panel for Leukemia

(MyeloGen Trial)

Overseen By Christopher R Reilly, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Christopher Reilly

Disqualifiers: Skin biopsy, Previous genetic testing

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new genetic test called the MyeloGen Gene Panel. It targets adults with myeloid malignancies, a type of blood cancer, or bone marrow failure diagnosed within the last six months. The trial aims to determine if this genetic test can identify potential genetic risk factors for these conditions. Participants will complete questionnaires, watch an educational video, and provide a small skin sample for testing. If the genetic test reveals any findings, a genetic counselor or doctor will explain the results. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future diagnostic tools.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What prior data suggests that the MyeloGen Gene Panel is safe for germline genetic testing in myeloid malignancies?

Research has shown that gene panels like the MyeloGen Gene Panel are generally safe and well-tolerated. These panels help identify genetic changes related to myeloid cancers, a type of blood cancer. The MyeloGen Gene Panel is still under study, and while specific safety data for it is not yet available, similar panels have been used safely in research.

The process typically involves taking a small sample of skin tissue, known as a skin biopsy, which is a common and low-risk procedure. Since this trial focuses on testing rather than treatment, no side effects from the gene panel itself are expected. However, the study includes a genetic test that can reveal genetic risks, and participants may need to consult a genetic counselor afterward. This process aims to provide helpful information and support, not to pose any risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MyeloGen Gene Panel is unique because it offers a personalized approach to leukemia treatment through genetic testing. Unlike traditional treatments like chemotherapy or targeted therapies, which often have a one-size-fits-all approach, the MyeloGen Gene Panel identifies specific genetic mutations in an individual’s leukemia. This allows for more tailored treatment plans, potentially improving outcomes and reducing unnecessary side effects. Researchers are excited about this method because it could lead to more precise and effective treatments for patients, enhancing the overall management of leukemia.

What evidence suggests that the MyeloGen Gene Panel is effective for myeloid malignancies?

Research shows that genetic tests like the MyeloGen Gene Panel, which participants in this trial will undergo, can enhance understanding of myeloid cancers, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). These tests examine multiple genes simultaneously to identify DNA changes linked to these diseases. Studies have shown that these tests help doctors better understand the disease and make more informed treatment decisions. For instance, one study found that these tests effectively detect rare cancer cells that might otherwise be missed. Another study demonstrated that these tests can predict disease progression, guiding treatment plans. Overall, the MyeloGen Gene Panel shows promise in providing crucial genetic information about myeloid cancers. ^{6 7 8 9 10}

Who Is on the Research Team?

Christopher R Reilly, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with myeloid malignancies, which are cancers affecting blood cell formation. Participants will undergo genetic testing to see if they have inherited genes that might increase their risk of these cancers.

Inclusion Criteria

I am 18 years old or older.

I was diagnosed with a blood disorder or bone marrow failure in the last 6 months.

Ability to understand and provide a signed and completed consent document in English

Exclusion Criteria

Participants who cannot safely undergo clinically indicated skin biopsy as adjudicated by the study team

I have had genetic testing for blood cancer risk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Baseline visit with questionnaires, educational video, and punch skin biopsy

1 week

1 visit (in-person)

Genetic Testing

Participants undergo germline genetic testing using the MyeloGen Gene Panel

10 weeks

Results notification via mail, follow-up appointment if positive

Follow-up

Participants are monitored via medical records for up to 2 years from time of study consent

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• MyeloGen Gene Panel

Trial Overview The MyeloGen Gene Panel, an investigational tool designed to detect genetic predispositions to myeloid malignancies, is being tested for its feasibility and effectiveness in identifying such genetic factors in patients.

How Is the Trial Designed?

Group I: MyeloGen Germline Testing Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Christopher Reilly

Lead Sponsor

Broad Institute of MIT and Harvard

Collaborator

Trials

21

Recruited

16,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9634881/

Next-Generation Sequencing Panel Test in Myeloid ... We aimed to evaluate the advantages of the next-generation sequencing panel testing in myeloid malignancies and clinical outcomes.

2. haematologica.org haematologica.org/article/view/11576

Outcomes and genetic dynamics of acute myeloid ... We performed a comprehensive analysis of patients with relapsed AML to determine the genetic dynamics and factors predicting survival.

3. ascopubs.org ascopubs.org/doi/10.1200/PO.20.00182

Impact of a 40-Gene Targeted Panel Test on Physician ... This study provides insights into how physicians are currently using multigene panels capable of detecting relatively rare AML cells.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949774423002194

P190: Validation of myeloid neoplasm next generation ... The assay is designed to analyze 40 DNA genes and 29 RNA fusion driver genes associated with myeloid malignancies, including AML, myelodysplastic syndrome (MDS) ...

5. nature.com nature.com/articles/s41375-023-01846-8

Outcome prediction by the 2022 European LeukemiaNet ... Per the 2022 ELN classification, 35% of patients were assigned to the favorable group, 24% to intermediate and 41% to the adverse group. This ...

6. illumina.com illumina.com/products/by-type/clinical-research-products/trusight-myeloid.html

TruSight Myeloid Sequencing Panel This sequencing research panel targets variants associated with myeloid malignancies such as AML, MDS, MPN, CML, CMML, and JMML.

7. geneglobe.qiagen.com geneglobe.qiagen.com/us/product-groups/qiaseq-targeted-dna-panels/DHS-003Z

QIAseq Targeted DNA Human Myeloid Neoplasms Panel Configure and order the QIAseq Targeted DNA Human Myeloid Neoplasms Panel for the detection of low-frequency variants using digital DNA sequencing.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07112287

Germline Testing for Predisposition to Myeloid Malignancies Also called a data safety and monitoring ... The MyeloGen Gene Panel is investigational Germline genetic testing using skin fibroblasts.

9. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39963&ver=6

Genomic Sequence Analysis Panels in the Treatment of ... Use this page to view details for the Local Coverage Determination for Genomic Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases.

10. atcc.org atcc.org/products/tcp-1010

Leukemia Cell Line Panel - TCP-1010 A panel of 7 leukemia cell lines representing Acute Myeloid Leukemia (AML) ... Safety Data Sheet Landing page for more information. Biosafety Icon BSL 1.