Status:
COMPLETED
Efficacy and Safety in Transfusion Independent Non-severe Aplastic Anemia
Lead Sponsor:
Bing Han
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Aplastic Anemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Aplastic anemia (AA) is a rare bone marrow failure disease characterized by bone marrow hypocellularity and peripheral blood pancytopenia. AA is divided into severe AA (SAA) and non-severe AA (NSAA) b...
Detailed Description
Recombined human erythropoietin (rhEPO) has been shown to increase the erythroid response and response rate when combined with IST for patients with newly diagnosed AA, either SAA or NSAA. Different f...
Eligibility Criteria
Inclusion
- age≥18 year-old;
- hemoglobin level between 60g/L\~10 g/dL;
- newly diagnosed patients have at least one of the followings: #absolute neutrophil count \<1.5×109/L, #platelet count \< 30×109/L, # hemoglobin level \< 100g/L;
- with normal baseline liver and kidney function;
- with no active infection; are not pregnant or nursing;
- agree to sign consent forms;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion
- Congenital aplastic anemia;
- Presence of chromosomal aberration;
- Evidence of a clonal hematologic bone marrow disorder (MDS, AML) on cytogenetics;
- Presence with PNH clone ≥50%;
- Patients received HSCT before;
- Uncontrolled infection or bleeding with standard treatment;
- Allergic to luspatercept CsA or accessories;
- HIV, HCV or HBV active infection or liver cirrhosis or portal hypertension;
- Patient with QTcF (Fridericia's QT correction formula) at screening \<450 msec, or\<480 msec with bundle branch block, as determined via the mean of a triplicate ECG and assessed at site, unstable angina pectoris, uncontrolled hypertension(\>180/100mmHg)#pulmonary artery hypertension;
- Have any concomitant malignancies within 5 years expect for local basal cell carcinoma of the skin;
- Past history of thromboembolic event, heart attack or stroke (including anti-phospholipid antibody syndrome) and current use of anticoagulants;
- Pregnant or nursing (lactating) woman;
- Have attended other clinical trials within 3 months
Key Trial Info
Start Date :
December 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2025
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05399732
Start Date
December 19 2022
End Date
April 15 2025
Last Update
September 16 2025
Active Locations (1)
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1
Peking union medical college hospital
Beijing, China