Instructions
If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.
Status:
Recruiting
Associated Drug(s):
Phase:
Phase 2
Gender:
Female
Male
Age Group:
18 years and older
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Diagnosis of MDS according to World Health Organization (WHO)/French American British (FAB) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease
- < 5% blasts in bone marrow.
- Peripheral blood white blood cell (WBC) count < 13,000/µL.
- Anemia defined as:
- In non-transfused participants, having received no red blood cell (RBC) transfusions within 8 weeks, Hgb concentration ≤ 10.0 g/dL OR
- In low transfusion burden (LTB) participants, having received 1 to 3 units RBCs for Hgb ≤ 9.0 g/dL within 8 weeks OR
- In high transfusion burden (HTB) participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia).
- Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.
Exclusion Criteria:
- Any active infection requiring parenteral antibiotic therapy within 28 days prior to Cycle 1 Day 1 or oral antibiotics within 14 days of Cycle 1 Day 1.
- Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
- Vitamin B12 deficiency.
- Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.
- Treatment within 28 days prior to Cycle 1 Day 1 with:
a. Erythropoiesis stimulating agent (ESA) OR
b. Granulocyte colony-stimulating factor (G-CSF) OR
c. Granulocyte-macrophage colony-stimulating factor (GM-CSF) - Iron chelation therapy if initiated within 8 weeks prior to Cycle 1 Day 1.
- Vitamin B12 therapy within 8 weeks prior to Cycle 1 Day 1.
- Treatment with another investigational drug or device or approved therapy for investigational use < or = 28 days prior to Cycle 1 Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Cycle 1 Day 1, whichever is longer.
- Platelet count > 450 x 10*9/L or < 30 x 10*9/L.
- Transferrin saturation < 15%.
- Ferritin < 50 µg/L.
- Folate < 4.5 nmol/L (< 2.0 ng/mL).
- Vitamin B12 < 148 pmol/L (< 200 pg/mL).
- Estimated glomerular filtration rate (GFR) < 40 mL/min/1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI].
- Pregnant or lactating females.