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Leukemia & Lymphoma Volume 58, 2017 - Issue 6
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Original Articles: Clinical

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

Beata HolkovaMassey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA; ;Department of Internal Medicine, Virginia Commonwealth University, Richmond, VA, USA; Correspondence[email protected]
,
Victor YazbeckMassey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA; ;Department of Internal Medicine, Virginia Commonwealth University, Richmond, VA, USA;
,
Maciej KmieciakMassey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA;
,
Prithviraj BoseMassey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA;
,
Shuo MaDivision of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA;
,
Amy KimballMarlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, MD, USA;
,
Mary Beth TombesMassey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA;
,
Ellen ShraderMassey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA;
,
Wen WanDepartment of Statistics, Virginia Commonwealth University, Richmond, VA, USA;
,
Caryn Weir-WigginsMassey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA;
,
Amanda SinghMassey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA;
,
Kevin T. HoganMassey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA;
,
Sarah ConineMassey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA;
,
Heidi SankalaMassey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA;
,
John D. RobertsMassey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA;
,
Thomas C. SheaDepartment of Hematology/Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA;
&
Steven GrantMassey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA; ;Department of Internal Medicine, Virginia Commonwealth University, Richmond, VA, USA; ;Department of Microbiology and Immunology, Virginia Commonwealth University, Richmond, VA, USA; ;Department of Biochemistry and Molecular Biology, Virginia Commonwealth University, Richmond, VA, USA; ;The Institute for Molecular Medicine, Virginia Commonwealth University, Richmond, VA, USA
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Pages 1349-1357 | Received 03 Aug 2016, Accepted 20 Dec 2016, Published online: 19 Jan 2017
 
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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.

Acknowledgements

The authors thank Elizabeth Stoddert Collins, MA, CCRP for assistance with data acquisition.

Potential conflict of interest

Disclosure forms provided by the authors are available with the full text of this article online at http://dx.doi.org/10.1080/10428194.2016.1276287.

Funding

This work was supported by the National Institute of Health [NCI R01 CA205607; NCI R01 CA167708; P50 CA 142509; NCI R21 CA137823; NCI P30 CA016059; NCRR M01 RR00065] and the Leukemia and Lymphoma Society [6472-15].

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