Efficacy and Safety of Bortezomib as First-line Treatment of Acquired TTP

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Nov 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called bortezomib as a first treatment option for patients with acquired Thrombotic Thrombocytopenic Purpura (TTP), a serious blood disorder that affects platelet levels and can lead to organ damage. In this study, participants will receive bortezomib along with standard treatments, including a procedure called plasma exchange, which helps remove harmful substances from the blood. The goal is to see if this combination can improve patients' conditions safely.

To participate in this trial, individuals must be 18 years or older and have a confirmed diagnosis of TTP. Certain health conditions, such as severe infections, known allergies to bortezomib, or serious kidney or liver problems, may prevent someone from joining. Participants can expect to receive intravenous injections of bortezomib and undergo plasma exchange treatments, with their progress closely monitored. It’s important to note that the trial is not yet recruiting participants, so those interested will need to wait until it begins.

Gender

ALL

Eligibility criteria

• 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.