Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT05937568
Eligibility Criteria:
Key Inclusion Criteria:
* Documented diagnosis of MDS according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and/or biopsy preferably within 24 but no more than 52 weeks prior to EAP start.
* Very Low, Low, or Intermediate risk MDS (≤3.5) per IPSS-R.
* Red blood cell (RBC) transfusion dependent, defined as requiring at least 4 RBC units over an 8-week period during the 16 weeks prior to EAP entry; pre-transfusion hemoglobin (Hb) should be less than or equal to 9.0 grams per deciliter (g/dL) to count towards the 4 units total.
* Has MDS that has failed to respond or has lost response or are ineligible for ESAs.
* To ensure participants have adequate iron stores they must have transferrin saturation greater than 20% and serum ferritin greater than 400 nanograms per milliliter (ng/mL).
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
* Hematology and biochemical laboratory test values within the protocol defined limits.
* Have no approved alternative treatment available.
* Inability to participate in a current imetelstat clinical study for the disease or conditions.
* Have a treating physician who has appropriately evaluated the benefit/risk profile for potential imetelstat treatment.
Key Exclusion Criteria:
* Have previously assessed as having IPSS-R high or very high risk MDS.
* Participant with del(5q) karyotype.
* Participant with MDS/myeloproliferative neoplasm Overlap Syndromes.
* Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients.
* Participant has received an experimental or investigational product or used an invasive investigational medical device within 30 days prior to EAP entry or is currently enrolled in an investigational study.
* Prior treatment with imetelstat; or eligible for enrollment in an ongoing imetelstat clinical trial.
* Prior treatment with lenalidomide or a hypomethylating agent (example, azacitidine, decitabine, or decitabine/cedazuridine).
* Has received an ESA or any anti-MDS therapy, chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to EAP entry.
* Prior history of hematopoietic stem cell transplant.
Note: Other protocol specified inclusion/exclusion criteria may apply.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05937568
Study Brief:
Protocol Section:
NCT05937568