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NCT Number: NCT05245032

Biologically Focused Therapy of Treatment-Refractory MDS Patients

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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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford MDS Center

Stanford, California, 94304, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of patients with successful ex vivo results

    Time frame: 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

  2. Proportion of patients with successful treatment decisions

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Notable Labs Inc.

Registry information

Official study title

Biologically Focused Therapy of Treatment Refractory MDS Patients

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2022
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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