Efficacy of Daratumumab to Overcome Platelet Transfusion Refractoriness in Patients With Aplastic Anemia
Aplastic Anemia, Platelet Transfusion Refractoriness
About this trial
This is an interventional treatment trial for Aplastic Anemia focused on measuring Platelet transfusion refractoriness, Daratumumab
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: The inherited bone marrow failure syndromes The presence of hemolytic PNH clone 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. 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 Abnormal liver function: ALT or AST > 2 ULN, or TBil > 2 ULN after treatment. Abnormal kidney function: Creatinine clearance < 30 ml/min Heart failure (NYHA class III or IV) 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 History of congestive heart failure, unstable angina pectoris, myocardial infarction, arterial or venous thrombosis Pregnant or breast-feeding patients Had a history of any psychiatric diseases, cerebrovascular disease or cognitive sequelae of head injury. Participation in another clinical trial within 4 weeks before the start of this trial Have an allergy to Daratumumab or any other part of this medicine. 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 Patients considered to be ineligible for the study by the investigator for reasons other than above
Sites / Locations
- Regenerative Medicine CenterRecruiting
Arms of the Study
Arm 1
Experimental
Daratumumab