Phase I/II study to determine the maximum tolerated dose and activity of the combination of romidepsin and carfilzomib in relapsed or refractory peripheral T-cell lymphoma

niversity of Birmingham (UK)0 sites58 target enrollmentDecember 11, 2013

Overview

No summary available.

Registry

who.int

Start Date

December 11, 2013

End Date

September 23, 2021

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Birmingham (UK)

•Current inclusion criteria as of 11/06/2018:
•1\. Aged \=16 years
•2\. Life expectancy \> 12 weeks
•3\. ECOG performance status \=2
•4\. Relapsed or refractory\* peripheral Tcell lymphoma including the following histologies: peripheral Tcelllymphoma not otherwise specified, angioimmunoblastic Tcell lymphoma, anaplastic large cell lymphoma, enteropathy associated Tcell lymphoma, extranodal NK/Tcell lymphoma, transformed mycosis fungoides, hepatosplenic Tcell lymphoma
•5\. Failed at least 1 prior therapy (but no upper limit of prior regimens)
•6\. Adequate haematopoietic reserve (Hb \= 9 g/dl, neutrophils \=1\.0x10(9\)/l and platelets \=100x10(9\)/l or \=75x10(9\)/l if marrow involvement documented)
•7\. Adequate liver function (bilirubin \=1\.5 x upper limit of normal (ULN) (unless due to Gilbert’s syndrome), AST / ALT \=2x ULN)
•8\. Adequate renal function (creatinine clearance \= 20ml/min as assessed by Cockcroft and Gault calculation)
•9\. Serum potassium \= 3\.8 mmol/l, calcium \= 2\.2 mmol/l and magnesium \= LLN prior to trial entry (supplements permitted)

•Current exclusion criteria as of 11/06/2018:
•1\. Persistent treatment related toxicities of CTCAE v4\.0 grade \= 2
•2\. Previous treatment with histone deactylase inhibitor or proteasome inhibitor
•3\. Need for any other concurrent anticancer drug (apart from corticosteroids at a dose equivalent to prednisolone \=7\.5mg daily). A steroid prephase may be used but should be stopped by the first day of cycle 1\.
•4\. Concurrent medical illness deemed by the investigator as uncontrolled and/or clinically significant
•5\. Coexisting active infection requiring parenteral antibiotics
•6\. Patients unable to swallow oral medication
•7\. Active infection with HIV, hepatitis B or hepatitis C
•8\. Radiotherapy\* (except for palliative reasons), endocrine therapy, immunotherapy or use of other investigationalagents within 28 days prior to trial entry (or a longer period depending on the defined characteristics of the agents used, please contact the trials office for confirmation). \*Limited field radiotherapy to an isolated lesion in bone or soft tissue must be completed 2 weeks prior to trial entry
•9\. Major surgery within 4 weeks of trial entry