PI3K Delta Inhibitor in Relapsed / Refractory Autoimmune Hemolytic Anemia Patients After Receiving Two or More Lines of Therapy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    20
  • sponsor
    Institute of Hematology & Blood Diseases Hospital
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Updated on 11 April 2023
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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.

Details
Condition Autoimmune Hemolytic Anemia, Failure of Two Rounds of Treatment
Treatment Linperlisib
Clinical Study IdentifierNCT05676697
SponsorInstitute of Hematology & Blood Diseases Hospital
Last Modified on11 April 2023

Eligibility

 Yes No Not Sure

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 < 0.5×10^9/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 participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract
Had a history of any psychiatric diseases, cerebrovascular disease or cognitive sequelae of head injury
Received rituximab in 6 weeks before enrollment
Received attenuated vaccine 4 in weeks before enrollment
Participation in another clinical trial within 4 weeks before the start of this trial
Have an allergy to Linperlisib or any other part of this medicine
Previously treated with other PI3Kδ inhibitor
Pregnant or breast-feeding patients
Patients considered to be ineligible for the study by the investigator for reasons other than the above
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