Luspatercept for CIA in AML

Korábbi kezelés

• Concurrent myelofibrosis
• History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization

Más betegség

• Heart function < grade 2
• Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
• Uncontrolled systemic fungal, bacterial, or viral infection (defined as persistent infection-related signs/symptoms that do not improve despite appropriate antibiotic, antiviral, and/or other treatments), known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) infection, and/or hepatitis C. (HCV) infection
• History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients

Laborértékek

• Renal function: creatinine clearance < 30 ml/min
• Liver function: ALTd > 5 times normal, bilirubin > 3 times normal

Egyéb

• t-AML/sAML
• Patients unresponsive to red blood cell transfusions
• Pregnant or breastfeeding women
• Patients deemed unsuitable for enrollment by the investigators

• De novo AML patients;
• Age ≥ 18 years and ≤ 60 years;
• AML with ELN2022-low risk
• Received 1-3 cycles of HDAC consolidation therapy
• HGB 60-90 G/L
• Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
• Life expectancy ≥ 3 months;
• Signed informed consent and able to understand and comply with the procedures required by this protocol.