New Clinical Trial for the Treatment of Autoimmune Hemolytic Anemia (AIHA)

Auto-immune hemolytic anemia (AIHA) is a rare and sometimes missed complication of CLL

Here is some information on a clinical trial for those with AIHA whose CLL is otherwise behaving itself, or those with no lymphoid cancers and only AIHA. Here is a direct link to the trial: https://clinicaltrials.gov/ct2/show/NCT02612558?term=NCT02612558&rank=1

Autoimmune hemolytic anemia (AIHA) is a rare disease characterized by the premature destruction of red blood cells (hemolysis).  It is a disorder that may occur as the result of, or in conjunction with, some other medical conditions (source: National Organization for Rare Disorders) .  About 5-10% of people with chronic lymphocytic leukemia or CLL develop autoimmune complications, the most common of which is AIHA (source: National Center for Biotechnology Information).  A Phase 2 clinical study of an investigational drug is seeking AIHA patients who meet the criteria below.  It is an open-label study (no placebo-control and all patients receive investigational drug) administered as an oral tablet taken twice a day.

Key eligibility criteria:

• Adults over the age of 18
• Diagnosis of warm antibody AIHA (including secondary to other diseases such as CLL)
• Failure of at least one prior AIHA treatment regimen
• Anemia, with hemoglobin less than 10 g/dL

Those who participate may continue treatment with a stable dose of steroids (e.g. prednisone), azathioprine, or ESAs (erythropoiesis stimulating agents) during the 12-week main study.  There is an optional extended treatment period for patients with improvement in anemia.

12 sites in the US are actively recruiting eligible patients.  For more information, please visit: www.aihastudy.com