Myelodysplastic Syndrome Clinical Trial

Biologically Focused Therapy of Treatment-Refractory MDS Patients

Summary

This non interventional study examines the feasibility of using patient specific therapeutic screening method, ex vivo to enhance current treatment recommendations in a clinically feasible time frame of 30 days.

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Full Description

This study utilizes the Notable Labs personalized testing service using an ex vivo assay, but does not involve actual treatment or treatment determinations. The results of these screenings will be made available to patients and their physicians for their use off study.

The primary objective of the study is:

• To determine the feasibility of selecting patient specific treatment regimens based on ex vivo within 30 days

The exploratory objectives of the study are:

• To identify biomarkers that explain ex vivo drug sensitivity results

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Eligibility Criteria

Inclusion Criteria:

Provide informed consent;
Myelodysplastic syndrome as defined by WHO classification (see Appendix 2), or MDS/MPN with >= 5% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) 1 and 2 by WHO classification
Relapsed/refractory disease, defined as failed or are ineligible for hypomethylating agent therapy
Cytogenetics reported

Exclusion Criteria:

Hypoplastic MDS
Patients without adequate marrow samples for ex vivo analysis

Study is for people with:

Myelodysplastic Syndrome

Estimated Enrollment:

33

Study ID:

NCT05245032

Recruitment Status:

Active, not recruiting

Sponsor:

Stanford University

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There is 1 Location for this study

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Stanford MDS Center
Stanford California, 94304, United States

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Study is for people with:

Myelodysplastic Syndrome

Estimated Enrollment:

33

Study ID:

NCT05245032

Recruitment Status:

Active, not recruiting

Sponsor:


Stanford University

How clear is this clinincal trial information?

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