Autoimmune Hemolytic Anemia Clinical Trials 2026 — Find Recruiting Studies

About Autoimmune Hemolytic Anemia

Autoimmune hemolytic anemia is a heterogeneous group of acquired disorders in which autoantibodies directed against red blood cell surface antigens accelerate erythrocyte destruction by complement activation and phagocytosis in the reticuloendothelial system. Warm AIHA involves IgG autoantibodies reactive at 37 degrees Celsius and accounts for approximately 70-80% of cases, while cold agglutinin disease involves IgM autoantibodies and cold hemolysins (paroxysmal cold hemoglobinuria) account for the remainder. When AIHA occurs with concurrent immune thrombocytopenia, the condition is called Evans syndrome and carries a more guarded prognosis.

Common Clinical Features

Rapidly developing anemia with pallor and fatigue Jaundice and dark urine from hemolysis Splenomegaly from splenic red cell sequestration Positive direct antiglobulin test (DAT/Coombs test) Elevated LDH, indirect bilirubin, and reticulocyte count Reduced or absent haptoglobin Cold-triggered acrocyanosis and Raynaud phenomenon in cold AIHA Thrombocytopenia if concurrent Evans syndrome

Clinical Trial Eligibility Tips

What to know before applying to Autoimmune Hemolytic Anemia trials.

Direct antiglobulin test (DAT) specificity (IgG, complement C3d, or both) and thermal amplitude of the causative antibody distinguish warm from cold AIHA and determine eligibility for specific trials targeting complement or B-cell pathways.

Primary versus secondary AIHA (secondary to lymphoma, SLE, or other autoimmune disease) affects eligibility; most trials require exclusion of active malignancy and documentation of underlying conditions.

Prior treatment history including corticosteroids, rituximab, splenectomy, and immunosuppressants with response assessment and duration is critical for second-line trial qualification.