Safety and Efficacy Study of PI3K Delta Inhibitor in Relapsed / Refractory Autoimmune Hemolytic Anemia Patients After Receiving Two or More Lines of Therapy
Status: Terminated
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a prospective, multicenter, single-arm, pilot study. The aim of this study is to evaluate the efficacy and safety of Linperlisib, the PI3K delta inhibitor for autoimmune hemolytic anemia patients who failed the second line therapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female age ≥ 18 years
• Diagnosis of primary warm antibody hemolytic anemia (AIHA).
• Hemoglobin \< 100g/L
• Refractory to or relapsed after at least 2 prior treatment line.
• ECOG performance status ≤ 2
• Willing and able to comply with the requirements for this study and written informed consent.
Locations
Other Locations
China
Regenerative Medicine Center
Tianjin
Zhoukou Central Hospital
Zhoukou
Time Frame
Start Date: 2023-01-13
Completion Date: 2024-02-06
Participants
Target number of participants: 4
Treatments
Experimental: PI3K Delta Inhibitor
Related Therapeutic Areas
Sponsors
Collaborators: YL-Pharma
Leads: Institute of Hematology & Blood Diseases Hospital, China