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Clinical Trials in China / NCT06964971
Starting soon Not applicable

Treatment of Transfusion-dependent Nonsevere Aplastic Anemia With Luspatercept: a Multicenter Prospective Clinical Study

NCT06964971 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University
Phase
Not applicable
Started
2025-05-20
Last updated
2025-05-11

Condition(s) studied

Transfusion-dependent Non-severe Aplastic Anemia

Investigational drug(s) / intervention(s)

LuspaterceptLuspatercept combine with Deferasirox

Luspatercept: The recommended starting dose of luspatercept is 1.5 mg/kg administered subcutaneously (SC) once every 3 weeks. Treatment response should be evaluated and dosage adjusted after at least 3 treatment cycles (9 weeks).

Luspatercept combine with Deferasirox: The recommended starting dose of luspatercept is 1.5 mg/kg administered subcutaneously (SC) once every 3 weeks. Treatment response should be evaluated and dosage adjusted after at least 3 treatment cycles (9 weeks). For patient with platelet counts \< 50×10⁹/L: Deferasirox dosage: 8-10 mg/kg/day, orally. For platelet counts ≥ 50×10⁹/L: Deferasirox dosage: 20 mg/kg/day, orally. Discontinue deferasirox if serum ferritin drops below 500 μg/L.

Study summary

The goal of this clinical trial is to learn whether Luspatercept alone or in combination with Deferasirox can promote hematopoietic function in patients with transfusion-dependent non-severe aplastic anemia, as well as to assess the safety and efficacy of this treatment approach.

The main questions it aims to answer is:

whether the combination therapy of Luspatercept and Deferasirox can improve hemoglobin levels in these patients.

Participants will receive Luspatercept every 3 to 5 weeks based on hemoglobin response, undergo complete blood counts every 1 to 3 weeks, and receive other necessary evaluations as required.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 1.Age \>= 18 years; 2.According to the "Chinese Guidelines for the Diagnosis and Treatment of Aplastic Anemia (2022 Edition)", the patient must be diagnosed with transfusion-dependent non-severe aplastic anemia (TD-NSAA) and meet the requirement of erythroid hyperplasia in bone marrow aspiration from the posterior iliac crest and/or sternum being more than 15%; 3.If not newly diagnosed with TD-NSAA, and there are combined primary disease maintenance medications, the following conditions must be met: 1. The patient has not received and does not consider HSCT or ATG treatment for at least the next six months; 2. If maintaining oral immunosuppressive therapy, the course must be at least 6 months and assessed as ineffective; 3. If maintaining androgen therapy, the course must be at least 3 months and assessed as ineffective; 4. If maintaining recombinant human erythropoietin therapy, the course must be at least 3 months and assessed as ineffective; 5. If maintaining thrombopoietin receptor agonist (TPO-RA) therapy, the duration must be \>=6 months with confirmed inefficacy, and a washout period of \>=1 month is required before study enrollment; 6. If the above maintenance medication durations are not met, a washout period of at least 1 month is required; 4.Serum ferritin level \>= 1000 ng/ml; 5.Complete whole exome sequencing and MDS/AA next-generation sequencing testing are required. Exclusion Criteria: * 1\. Severe hepatic dysfunction (ALT or AST ≥ 3 × ULN); 2.Severe renal impairment (eGFR \< 30 ml/min/1.73m² or patients with end-stage renal disease); 3.Cardiac disease, including New York Heart Association (NYHA) Class 3 or higher heart failure, or severe arrhythmia requiring treatment, or recent myocardial infarction within 6 months of randomization; 4.Patients with uncontrolled hypertension, with controlled hypertension according to NCI CTCAE version 5.0 considered as ≤ Grade 1 for this protocol; 5.Patients with a PNH clone \> 1%; 6.Patients planning to become pregnant or who are pregnant; 7.Surgical or clinical conditions that may significantly alter drug absorption, distribution, metabolism, or excretion (e.g., gastritis, ulcers, history of gastrointestinal or rectal bleeding; history of major gastrointestinal surgery); 8.Patients carrying congenital bone marrow failure-related gene mutations (homozygous or heterozygous, regardless of whether they are pathogenic/benign/likely benign/ of uncertain significance).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Zhejiang Chinese Medical University Hangzhou Zhejiang

More The First Affiliated Hospital of Zhejiang Chinese Medical University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06964971 on ClinicalTrials.gov ↗ ← All trials in China