Efficacy and Safety in Transfusion Independent Non-severe Aplastic Anemia (NCT05399732) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety in Transfusion Independent Non-severe Aplastic Anemia
China58 participantsStarted 2022-12-19
Plain-language summary
Aplastic anemia (AA) is a rare bone marrow failure disease characterized by bone marrow hypocellularity and peripheral blood pancytopenia. AA is divided into severe AA (SAA) and non-severe AA (NSAA) based on the degree of cytopenia. The first line therapy for SAA or transfusion dependent NSAA is either immunosuppression therapy (IST) or hematopoietic stem cell transplantation (HSCT). Little attention has been paid to patients with anemia but not transfusion dependent, whose quality of life is significantly impaired due to the anemia and other complications.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. age≥18 year-old;
✓. hemoglobin level between 60g/L\~10 g/dL;
✓. newly diagnosed patients have at least one of the followings: #absolute neutrophil count \<1.5×109/L, #platelet count \< 30×109/L, # hemoglobin level \< 100g/L;
✓. with normal baseline liver and kidney function;
✓. with no active infection; are not pregnant or nursing;
✓. agree to sign consent forms;
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion criteria
✕. Congenital aplastic anemia;
✕. Presence of chromosomal aberration;
✕. Evidence of a clonal hematologic bone marrow disorder (MDS, AML) on cytogenetics;
✕. Presence with PNH clone ≥50%;
✕. Patients received HSCT before;
✕. Uncontrolled infection or bleeding with standard treatment;