Efficacy of Daratumumab to Overcome Platelet Transfusion Refractoriness in Patients with Aplastic… (NCT05832216) | Clinical Trial Compass
CompletedPhase 1
Efficacy of Daratumumab to Overcome Platelet Transfusion Refractoriness in Patients with Aplastic Anemia
China10 participantsStarted 2023-04-17
Plain-language summary
This is a phase 1, prospective, single-arm, open-label study. The aim of this study is to evaluate the transfusion responses of platelet increment by using Daratumumab among aplastic anemia patients with platelet transfusion refractoriness.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Diagnosis of aplastic anemia (AA)
* Dependent on platelet transfusions, characterized by either PLT\<10Ă—10\^9/L, or PLT\<20Ă—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
* Histor…
What they're measuring
1
Percentage of patients with platelet transfusion responsiveness
Timeframe: 12 weeks
Trial details
NCT IDNCT05832216
SponsorInstitute of Hematology & Blood Diseases Hospital, China