Not Yet RecruitingNot Applicable

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

China90 participantsStarted 2025-05-20

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. The patient has not received and does not consider HSCT or ATG treatment for at least the next six months;
✓. If maintaining oral immunosuppressive therapy, the course must be at least 6 months and assessed as ineffective;
✓. If maintaining androgen therapy, the course must be at least 3 months and assessed as ineffective;
✓. If maintaining recombinant human erythropoietin therapy, the course must be at least 3 months and assessed as ineffective;
✓. 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;
✓. 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.

What they're measuring

Hemoglobin

Timeframe: Baseline (1 month before treatment), treatment phase: 12 weeks (twice weekly in weeks 1 / 2, once weekly in week 3, once every 3 weeks ), mid-treatment phase: 12 weeks (once every 3 weeks), follow-up period: 48 weeks (once every 12 weeks).

Trial details

NCT IDNCT06964971

SponsorThe First Affiliated Hospital of Zhejiang Chinese Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-20

Contact for this trial

Dijiong Wu, Ph.D.

+86 13989463963 wudijiong@zcmu.edu.cn

View on ClinicalTrials.gov More Transfusion-dependent Non-severe Aplastic Anemia trials