OncoMatch/Clinical Trials/NCT06304103
A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome
Is NCT06304103 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies AND017 for myelodysplastic syndromes.
Treatment: AND017 — This is a Phase 2, multicenter, randomized, open-lable, dose ranging study to evaluate the efficacy and safety of AND017 for the treatment of anemia due to lower risk Myelodysplastic syndromes (MDS) in patients subjects who are Red blood cell (RBC) non-transfusion dependent (NTD) and low transfusion burden (LTB).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Myelodysplastic Syndrome
Disease stage
Required: Stage VERY LOW, LOW, INTERMEDIATE (IPSS-R)
Excluded: Stage HIGH, VERY HIGH
PISS-R grading of very low, low or intermediate risk
Demographics
Prior therapy
Cannot have received: granulocyte colony-stimulating factor
Received granulocyte colony-stimulating factor (G-CSF) ... within 8 weeks prior to the first dose
Cannot have received: thrombopoietin or thrombopoietin receptor agonist
Received ... thrombopoietin, or thrombopoietin receptor agonist therapy within 8 weeks prior to the first dose
Cannot have received: antithymocyte globulin
Treatment with antithymocyte globulin ... within 12 weeks prior to the first dose
Cannot have received: hypomethylating agent (azacitidine, decitabine)
Treatment with ... azacitidine, decitabine ... within 12 weeks prior to the first dose
Cannot have received: calcineurin inhibitor (cyclosporine)
Treatment with ... cyclosporine ... within 12 weeks prior to the first dose
Cannot have received: immunomodulatory agent (thalidomide, lenalidomide)
Treatment with ... thalidomide, or lenalidomide within 12 weeks prior to the first dose
Cannot have received: hypoxia-inducible factor-prolyl hydroxylase inhibitor
Have been treated with any other hypoxia-inducing factor-prolyl hydroxylase inhibitor (HIF-PHI) in the 8 weeks prior to the first dose
Cannot have received: erythropoiesis-stimulating agent
Have been treated with an erythropoietic ESA within 8 weeks prior to the first dose
Cannot have received: androgenic anabolic steroid (testosterone enanthate, methandrostenolone)
Have been treated with an androgenic anabolic steroid, testosterone enanthate or methandrostenolone within 8 weeks prior to the first dose
Cannot have received: iron chelator
Have been treated with an iron chelator within 8 weeks prior to the first dose
Cannot have received: hematopoietic stem cell transplant
Prior or planned hematopoietic stem cell transplant during the study period
Lab requirements
Blood counts
Platelets ≥ 30,000 /mm3 and absolute neutrophil count ≥ 800/mm3
Liver function
Total bilirubin <2 x ULN (Gilbert's syndrome: <3 x ULN); AST <3 x ULN; ALT <3 x ULN
Platelets ≥ 30,000 /mm3 and absolute neutrophil count ≥ 800/mm3; Adequate liver function with: Total bilirubin <2 x ULN (subjects with Gilbert's syndrome, i.e., unconjugated hyperbilirubinemia, have a total bilirubin <3 x ULN); AST <3 x ULN; ALT <3×ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06304103 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior granulocyte colony-stimulating factor, thrombopoietin or thrombopoietin receptor agonist, antithymocyte globulin disqualifies patients from enrollment.
What disease stage is eligible?
Stage VERY LOW or LOW or INTERMEDIATE is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages