Not Yet RecruitingPhase 4

A Prospective Study on the Treatment of Recurrent/Refractory/Intolerable NSAA With Lusutrombopag

China40 participantsStarted 2024-06

Plain-language summary

In a prospective, single-arm study, the efficacy and safety of Lusutrombopag in the treatment of relapsed/refractory/intolerable non-severe aplastic anemia (NSAA) were explored.

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. Participants must be at least 18 years old, male or female.
✓. Participants must be diagnosed with NSAA and have a refractory/relapsed/intolerable response to standard-dose cyclosporine (CsA). The definition of refractory/relapsed is patients who have been treated with sufficient doses of cyclosporine (3-5mg/kg) for at least 6 months without response or relapse. The definition of intolerable is patients who cannot tolerate CsA and have stopped treatment due to significant side effects.
✓. Participants must meet the following criteria at enrollment: platelets \<30×109/L.
✓. Baseline liver and kidney function must be within 2 times of normal range.
✓. No active infection; no pregnancy or breastfeeding.
✓. Participants must agree to sign the informed consent form.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

Exclusion criteria

✕. Other causes of pancytopenia, such as myelodysplastic syndrome (MDS).
✕. Evidence of clonal hematopoietic system bone marrow disease (MDS, AML) with cytogenetics.
✕. PNH clone ≥50%.
✕. Received hematopoietic stem cell transplant (HSCT) prior to enrollment.
✕. Received ATG treatment within 6 months prior to enrollment.
✕. Infection or bleeding that cannot be controlled with standard therapy.
✕. Allergic to ruxolitinib.
✕. Active HIV, HCV, or HBV infection, cirrhosis, or portal hypertension.

What they're measuring

Overall response rate at 3 months

Timeframe: 3 month

Overall response rate at 6 months

Timeframe: 6 month

Trial details

NCT IDNCT06426043

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06

Contact for this trial

Bing Bing, PhD

13601059938 Hanbing_li@sina.com.cn

View on ClinicalTrials.gov More Aplastic Anemia trials