Luspatercept for CIA in AML

Summary

This study aims to explore the feasibility, safety, and preliminary efficacy of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML with a multicenter, prospective, single-arm trial, providing clinical evidence for subsequent clinical development.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. t-AML/sAML
2. Concurrent myelofibrosis
3. Patients unresponsive to red blood cell transfusions
4. Heart function \< grade 2
5. Renal function: creatinine clearance \< 30 ml/min
6. Liver function: ALTd \> 5 times normal, bilirubin \> 3 times normal
7. Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
8. History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization
9. 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
10. History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients
11. Pregnant or breastfeeding women
12. Patients deemed unsuitable for enrollment by the investigators

Conditions2

Interventions1

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