Efficacy and Safety of Bortezomib as First-line Treatment of Acquired TTP (NCT05135442) | Clinical Trial Compass
UnknownPhase 4
Efficacy and Safety of Bortezomib as First-line Treatment of Acquired TTP
China30 participantsStarted 2021-12-01
Plain-language summary
To evaluate the efficacy and safety of bortezomib in the first-line treatment of patients with acquired TTP，we design this prospective, multi-center, single-arm interventional study.All enrolled TTP patients were given bortezomib 1.3 mg/m2 intravenous injection d1, 4, 8, on the basis of standard single membrane plasma exchange (2L/d) and hormone therapy (1mg/kg prednisone or equivalent methylprednisolone). 11 (4 doses in total). Bortezomib should be administered immediately after each plasma exchange, and the interval between the next plasma exchange is\> 24h. Plasma exchange continued until the patient's platelet count was \>100×109/L for 2 consecutive days, and then changed to once every other day for a total of two times and then stopped.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* clinically diagnosed as TTP (thrombocytopenia + MAHA± clinical evidence of related organ damage， a significant reduction in ADAMTS13 activity level and/or positive antibody screening）
* elder than 18 years old;
* informed consent is required;
Exclusion Criteria:
* Uncontrollable systemic infection;
* Known allergy to bortezomib;
* Expected survival time \<1 week;
* Pregnant or lactating women (women of childbearing age have a positive pregnancy test at baseline or have not received a pregnancy test. Postmenopausal women must be at least 12 months after menopause);
* If the creatinine level is ≥200μmol/l (1.5mg/dl), the levels of transaminase and bilirubin are 2 times higher than the upper limit of normal (except due to the primary disease);
* Known congenital TTP or a clear family history of TTP;
* Other diseases that cause microangiopathic hemolysis and thrombocytopenia, such as DIC, APS, HUS, malignant hypertension, transplantation-related microangiopathy;
* active malignant tumors (except skin basal cell carcinoma or cervical carcinoma in situ) ( have not been treated or recurred within 5 years before signing the informed consent);
* peripheral neuropathy;
* Patients or family members cannot understand the conditions and goals of this study;
* The investigator believes that the patient should not participate in any other situations in this trial.
What they're measuring
1
Time to clinical remission and the number of plasma exchanges required