Efficacy of Daratumumab to Overcome Platelet Transfusion Refractoriness in Patients with Aplastic Anemia

Who can take part

• Diagnosis of aplastic anemia (AA)
• Dependent on platelet transfusions, characterized by either PLT<10×10\^9/L, or PLT<20×10\^9/L with bleeding events
• Diagnosed with platelet transfusion refractoriness, characterized by Corrected count increment (CCI) <7500/ul at 60 min, or CCI <4500/ul at 24 hrs
• Male or female age ≥ 12 years
• ECOG performance status ≤2
• Willing and able to comply with the requirements for this study and written informed consent

Who cannot take part

• Combination of either radiotherapy or chemotherapy for solid tumors in recent 3 years, excluding the local tumor diagnosed 1 year ago and cured by surgical resection
• Participation in another clinical trial within 4 weeks before the start of this trial
• Previously treated with Daratumumab
• Previously treated with ATG/ALG within 4 months before the start of this trial
• Previously treated with the anti-CD20 monoclonal antibody within 2 months before the start of this trial
• Currently treated with TPO-RA except for a minimum of 4 weeks for washout before the start of this trial
• The inherited bone marrow failure syndromes
• Cytopenia caused by other diseases, including liver cirrhosis, active rheumatic connective tissue disease, and persistence of infectious diseases, etc
• Uncontrolled infection
• HIV, HCV or HBV active infection
• The presence of any of the following bleeding events:; Gastrointestinal bleeding; Respiratory tract hemorrhage; Central nervous system bleeding
• Heart failure (NYHA class III or IV)
• History of congestive heart failure, unstable angina pectoris, myocardial infarction, arterial or venous thrombosis
• Had a history of any psychiatric diseases, cerebrovascular disease or cognitive sequelae of head injury
• Have an allergy to Daratumumab or any other part of this medicine
• Abnormal liver function: ALT or AST > 2 ULN, or TBil > 2 ULN after treatment
• Abnormal kidney function: Creatinine clearance < 30 ml/min
• Poorly controlled diabetes, characterized by fasting blood glucose > 8.8mmol/L or post-meal blood glucose > 11.1mmol/L after therapy with insulin or oral hypoglycemic agents
• The presence of hemolytic PNH clone
• Pregnant or breast-feeding patients
• Patients considered to be ineligible for the study by the investigator for reasons other than above