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NOT YET RECRUITING
NCT06964971
NA

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

Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-05-20

Completion Date

2027-06-30

Last Updated

2025-05-11

Healthy Volunteers

No

Interventions

DRUG

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).

DRUG

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.

Locations (1)

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China