Recurrent / refractory acquired hemophilia
Conditions
Interventions
trial group:Subcutaneous injection of bortezomib(1.3mg/m2), d1, 4,8,11, 28-day cycle,acyclovir(0.2 tid) for the prevention ofviral infection, small dose of SMZco(0.48 bid) for the prevention ofpneumoc
Sponsors
Department of Hematology of Anhui Provincial Hospital, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with relapsedrefractory acquired hemophiliawho meet the requirements ofthis study protocol for first -andsecond-line treatment: A.Patients with acquired hemophilia Aconfirmed by factor Vlll activity andfactor Vlll inhibitor testing, and patientswith acquired hemophilia B confirmedby factor lX activity and factor lXinhibitor testing, who have not achieveoa partial response (PR) assessed by first.line therapy, And the patients whoachieved the efficacy above PR showedoss or progress of efficacy; B.At least 14 years of age, regardless ofgender or race; C.Physical condition: ECOG score 0-3points; D. Cardiac function: left ventricular ejection fraction greater than or equalto 40%; E. Expected survival time >12 weeks; F.Serum creatinine (Cr) =1.5xULN (uppellimit of normal), alanine aminotransferase(ALT) and aspartateaminotransferase (AST) =2.5xULN, totabilirubin s1.5xULN; G.Patients have self-awgreness and cansign informed consent: The quardian ofthe child patient agrees to sign theinformed consent; H. Breastfeeding women participating in the study were required to stop breastfeeding;
Exclusion criteria
Exclusion criteria: Exclusion criteria of patients: A.Patients with hereditaryhemophilia and vonwillebrand disease areexcluded; B.Contraindicated in patientsallergic to bortezomib and anyof its components (includingbortezomib, boron andmannitol) C.Pregnant women,Breastfeeding womenwho do not agree tostop breastfeeding; D.Active HBV or HCV infection; E.HIV infected persons;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactJuan Tong
Department of Hematology of Anhui Provincial Hospital, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Outcome results
None listed