Biologically Focused Therapy of Treatment-Refractory MDS Patients

NCT05245032 | Completed

• 2 other identifiers: IRB-45236HEMMDS0035
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndromes

Keywords

MDS

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with successful ex vivo results

  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

  30 days

• Proportion of patients with successful treatment decisions

  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

  30 days

Study Arms (1)

Feasibility testing

During the screening visit, blood and/or a bone marrow sample will be obtained for the patient's standard clinical evaluation. An aliquot of the blood and/or marrow sample will be obtained for ex vivo drug sensitivity assay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will be conducted at a single site, namely Stanford's MDS Center.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Notable Labs Inc.: collaborator

Study Sites (1)

Stanford MDS Center

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Peter L Greerberg

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 17, 2022
• Study Start: February 18, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)