A phase 1 study of bortezomib and romidepsin in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, indolent B-cell lymphoma, peripheral T-cell lymphoma, or cutaneous T-cell lymphoma
Year: 2017
Type: article
Study design: Clinical Trial
Abstract: A phase 1 study was conducted to determine the dose-limiting toxicities and maximum-tolerated dose (MTD) for bortezomib followed by romidepsin on days 1, 8, and 15 in patients with relapsed/refractory CLL/SLL or B- or T-cell lymphoma. Eighteen treated patients were evaluable for response. The MTD was 1.3 mg/m2 bortezomib and 10 mg/m2 romidepsin; median treatment duration was 3 cycles at this dose. The dose-limiting toxicities were grade 3 fatigue, vomiting, and chills. Two patients had partial responses, one lasting >2 years, 8 had stable disease, and 8 had progressive disease. The median duration of stable disease was 3.5 cycles. Correlative studies examining expression of NF-кB, XIAP, Bcl-xL, and Bim yielded variable results. The safety profile was consistent with that reported for single-agent bortezomib and romidepsin. This regimen has modest activity in heavily pretreated patients with relapsed/refractory CLL or B- or T-cell lymphoma. NCT00963274.
Institutions: Virginia Commonwealth University, VCU Massey Comprehensive Cancer Center, Northwestern University, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, University of Maryland, Baltimore, University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center
Language: English
Subfield: Genetics
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G1044130170, G1353051725, G1527479329, Targeting Multiple Myeloma with Smac-mimetics and HDAC Inhibitors, General Clinical Research Center, Massey Cancer Center - Cancer Center Support Grant, Yale Clinical and Translational Science Award, Phase I Trial of Bortezomib and Romidepsin in CLL and Small Cell Lymphoma
OpenAlex ID: W2577930388