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Recruiting NCT07663864

Luspatercept for CIA in AML

Phase I / Phase II Interventional Chemotherapy-inducing Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Luspatercept Injectable Product.
Who it may be relevant to
Registry conditions: Chemotherapy-inducing Anemia. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

The application of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML has not yet been systematically studied. Animal studies have shown that rotegcipipone can improve the recovery of anemia after chemotherapy. The bone marrow microenvironment after chemotherapy is often deteriorated due to cytokine storms and hematopoietic stem cell damage, which may further exacerbate erythroid regeneration disorders. Based on rotegcipipone's dual mechanism of improving the hematopoietic microenvironment and promoting erythrocyte maturation, it may overcome the limitations of existing therapies after chemotherapy. Furthermore, its safety profile (primarily grade 1-2 adverse reactions in MDS and β-thalassemia) provides a potential advantage for its application in vulnerable patients after chemotherapy.

Interventions

  • Drug Luspatercept Injectable Product
    First, enrolled patients were randomized to received rotezipeptide with a dosage of 1mg/kg at the day 1 versus day 10 post chemotherapy. Each groups were analyzed to enroll et least 10 patients. Second, after working out which day should be the better one for the treatment of rotezipeptide in phase 1 study, at least 20 patients were enrolled to received rotezipeptide with the same dose at the above day to further work out the efficacy and safety of rotezipeptide in the treatment of CIA in AML.

Primary outcome measures

  • Time of 50% increase in hemoglobin levels from baseline [Time frame: Days 1-28 post chemotherapy]
Secondary outcome measures (5)
  • Duration of HGB < 60 G/L during the treatment course (1-28 days) [Time frame: Days 1-28 after AML chemistry treatment]
  • Incidence of HGB < 60 G/L during the treatment course (days 1-28) [Time frame: Days 1-28 after chemotherapy]
  • Red blood cell transfusion volume [Time frame: Days 1-28 after AML chemistry treamtment]
  • MRD negative rate [Time frame: 6 months after AML chemistry treamtment]
  • Anemia recurrence rate [Time frame: 12 months after AML chemistry treamtment]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Hematology, Guangdong Second Provincial General Hospital — Guangzhou

Identifiers

NCT: NCT07663864 · GD2H-2026-483

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗