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Taking people in ChinaPhase 1/2

Tests luspatercept for chemotherapy-related anemia in adults with acute myeloid leukemia

Tests luspatercept for low red blood cells caused by chemotherapy in adults with leukemia.

Plain-language title generated from the registry record
Registry title: Luspatercept for CIA in AML

Key facts

Where
Guangzhou, ChinaSee the site
Phase
Phase 1/2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 60 with newly diagnosed acute myeloid leukemia (AML), low risk by ELN2022, who have anemia after chemotherapy.

Age
18 to 60 years
Sex
All sexes can join.
Disease stage
Newly diagnosed (de novo) AML with ELN2022-low risk. Haemoglobin (HGB) 60-90 G/L. ECOG score 2 or lower. Life expectancy of at least 3 months.
Earlier treatment
Must have had 1-3 cycles of HDAC consolidation therapy.

Main reasons for not taking part

  • AML caused by earlier treatment or an earlier blood disease (t-AML/sAML)
  • Myelofibrosis at the same time
  • Not responding to red blood cell transfusions
  • Known HIV, active hepatitis B or hepatitis C infection, or uncontrolled infection
  • Pregnant or breastfeeding women

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 60 years old?

Source: NCT07663864, who can take part

Where in China

  • Department of Hematology, Guangdong Second Provincial General HospitalGuangzhou, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Guangdong Second Provincial General Hospital
Trial code
NCT07663864
Record updated
23 June 2026
Original description
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.Read full original descriptionShow less

Efficacy and Safety of Luspatercept in Treating Chemotherapy-inducing Anemia in Acute Myeloid Leukemia: a Multicenter, Prospective, Single-arm Study

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.

Inclusion: 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.

Exclusion: Concurrent myelofibrosis; History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization; 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; Renal function: creatinine clearance < 30 ml/min; Liver function: ALTd > 5 times normal, bilirubin > 3 times normal; t-AML/sAML; Patients unresponsive to red blood cell transfusions; Pregnant or breastfeeding women; Patients deemed unsuitable for enrollment by the investigators.

ClinicalTrials.gov NCT07663864