Biologically Focused Therapy of Treatment-Refractory MDS Patients

Active, not recruiting

• Conditions: Myelodysplastic Syndromes

• Registration Number: NCT05245032
• Lead Sponsor: Stanford University

Brief 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.

Detailed 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-02-18
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

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

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Exclusion Criteria

• Hypoplastic MDS
• Patients without adequate marrow samples for ex vivo analysis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with successful ex vivo results	30 days	Proportion of patients with successful ex vivo results within a 30 day period from the time marrow sample is sent to Notable Labs for ex vivo testing
Proportion of patients with successful treatment decisions	30 days	Proportion of patients with successful treatment decisions made by the molecular oncology board within a 30 day period from the time marrow sample is sent to Notable Labs for ex vivo testing

Trial Locations

Locations (1)

Stanford MDS Center; 🇺🇸 Stanford, California, United States