Luspatercept for CIA in AML

Recruiting now · Phase 1/Phase 2

Conditions studied: Chemotherapy-inducing Anemia

In brief

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.

Key facts

Study ID

NCT07663864

Run by

Guangdong Second Provincial General Hospital

People needed

40

Starts

2026-06-01

Expected to finish

2027-05-31

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Department of Hematology, Guangdong Second Provincial General Hospital — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.