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Expanded Access for Treatment With Imetelstat

NCT05937568 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2024-06-24

No results posted yet for this study

Summary

The objective of this expanded access protocol (EAP) is to provide access to treatment with imetelstat, the Investigational Product (IP), for eligible adult participants diagnosed with very low, low, intermediate risk (by Revised International Prognostic Scoring System, IPSS-R) myelodysplastic syndromes (MDS) who are red blood cell (RBC) transfusion-dependent, have failed to respond or have lost response or are ineligible for ESAs, had not received prior treatment with either a hypomethylating agent or lenalidomide and were non-del(5q), until such time that imetelstat becomes commercially available.

Conditions

Interventions

DRUG

Imetelstat

Participants will receive imetelstat, intravenously (IV) by infusion every 4 weeks.

Sponsors & Collaborators

  • Geron Corporation

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05937568 on ClinicalTrials.gov