PI3K Delta Inhibitor in Relapsed / Refractory Autoimmune Hemolytic Anemia Patients After Receivin… (NCT05676697) | Clinical Trial Compass
TerminatedPhase 1
PI3K Delta Inhibitor in Relapsed / Refractory Autoimmune Hemolytic Anemia Patients After Receiving Two or More Lines of Therapy
Stopped: Did not meet the anticipated outcome.
China4 participantsStarted 2023-01-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Neutrophils counts \< 0.5Ă—10\^9/L or platelet counts \< 50 x 10\^9/L
* Diagnosis of any of the following diseases: Cold agglutinin disease, cold agglutinin syndrome, mixed AIHA, paroxysmal cold hemoglobinuria (PCH).
* Diagnosis of the active stage of the connective tissue or systemic autoimmune rheumatic diseases (SARDs)
* History of lymphoproliferative neoplasms
* Had other inherited or acquired hemolytic diseases.
* Secondary AIHA caused by drugs or infection
* Previously received organ or stem cell transplantation.
* Had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors
* Patients with HBV, HCV, HIV or other infections that require treatment.
* Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal values
* Renal impairment: creatinine clearance \<60ml/min
* Any severe and/or uncontrolled medical conditions or other conditions that could affect their particip…
What they're measuring
1
Overall response rate
Timeframe: 6-12 weeks
Trial details
NCT IDNCT05676697
SponsorInstitute of Hematology & Blood Diseases Hospital, China