Expanded Access Program for Imetelstat Treatment

Inclusion Criteria

• Diagnosed with myelodysplastic syndromes (MDS) confirmed by a bone marrow test within the last year.
• Classified as very low, low, or intermediate risk MDS.
• Requires regular red blood cell transfusions, needing at least 4 units over 8 weeks in the last 16 weeks.
• MDS has not responded to or is not eligible for ESAs.
• Must have adequate iron levels in the blood.
• General health status should be relatively good, with an ECOG score of 0, 1, or 2.
• Blood and other lab tests must be within certain limits.
• No other approved treatment options available.
• Cannot join a current imetelstat clinical trial.
• Must have a doctor who has evaluated the potential benefits and risks of imetelstat treatment.

Exclusion Criteria

• Previously assessed as having high or very high risk MDS.
• Has a specific genetic abnormality known as del(5q).
• Has overlapping MDS/myeloproliferative neoplasm syndromes.
• Allergic or intolerant to imetelstat or its ingredients.
• Has used experimental treatments or devices recently or is in another study.
• Previously treated with imetelstat or eligible for an ongoing imetelstat trial.
• Previously treated with lenalidomide or certain other drugs.
• Received any MDS treatment or certain therapies within the last 4 weeks.
• Has had a stem cell transplant in the past.