Biologically Focused Therapy of Treatment-Refractory MDS Patients

Biologically Focused Therapy of Treatment Refractory MDS Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05245032

Enrollment

Registered

2022-02-17

Start date

2020-02-18

Completion date

2022-12-01

Last updated

2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes

Keywords

MDS

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results