A phase II study of Bortezomib for relapsed/refractory adult T-cell leukemia/lymphoma (ATL) - A phase II study of Bortezomib for AT
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 25
Study Overview
Brief Summary
Adult T-cell leukemia/lymphoma (ATL) is a malignancy of peripheral T-lymphocytes with a poor prognosis. This multicenter, two-stage, single-arm, phase II study assessed the efficacy and safety of bortezomib in patients with relapsed/refractory ATL who received at least one regimen of chemotherapy. The primary endpoint was the best overall response rate (ORR), and secondary endpoints included safety, the best response by lesions, and progression-free survival (PFS). Fifteen patients were enrolled in the first stage of this study. One partial remission (PR) and five stable disease (SD) were observed as the best overall responses, and ORR was 6.7% (95% confidence interval (C.I.) 0.17-31.95%). Responses according to disease sites were one complete remission (CR) in peripheral blood, two PR in measurable targeted lesions, and two PR in skin lesions. Progression-free survival (PFS) was 38 (95% CI; 18-106) days. All patients developed >=1 adverse events (AEs), and 80% of patients had >=1 grade 3/4 AEs; however, no new safety findings were obtained. Although these results fulfilled the planned settings to proceed to the second stage, the coordinating committee decided to terminate this study because single agent activity did not appear to be very promising for this cohort of patients.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1) History of treatment by bortezomib 2) Hypersensitivity to bortezomib, mannitol or boron. 3) History of administration of other investigational agents within 4 weeks before informed consent. 4) Interstitial pneumonia or pulmonary fibrosis. 5) Class III or IV (NYHA) cardiac disease, and/or either of cardiac infarction within 6 months before the informed consent, uncontrollable angina, severe ventricular arrhythmia, acute coronary ischemia, or symptomatic conduction block 6) Active infection 7) Suspicious findings of central nervous invasion 8) Grade 2 or higher peripheral neuropathy, or grade 1 or higher neuralgia 9) Either of cardiac failure, renal failure, hepatic failure, uncontrollable hypertension or uncontrollable diabetes mellitus. 10) Psychological disturbance 11) Synchronous or metachronous malignancy 12) HBs-Ag positive or HBc-Ab positive with HBV-DNA positive 13) HCV-Ab positive, HIV positive 14) Pregnant or nursing women