A phase II trial of Cyclosporin A in early adverse risk Chronic Lymphocytic Leukaemia (CLL)

niversity of Birmingham (UK)0 sites5 target enrollmentMarch 5, 2014

Overview

No summary available.

Registry

who.int

Start Date

March 5, 2014

End Date

April 29, 2015

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Birmingham (UK)

•1\. Stage A or B CLL (Binet system) not requiring therapy by conventional criteria
•2\. \= 2 lines of previous therapy for CLL
•3\. Male and female, age \=18
•4\. ECOG performance status \=2
•5\. Life expectancy \>12 months
•6\. No therapy for CLL in previous 3 months (including glucocorticoids)
•7\. CD38\+ve \= 7%
•8\. Normal renal function (eGFR \>60mls/min)
•9\. Normal liver function (AST and / or ALT \<1\.5 ULN)
•10\. Negative serology for Hepatitis B, C and HIV

•1\. Active infection
•2\. Active autoimmune disease (requiring therapy)
•3\. Diabetes Mellitus
•4\. Previous myocardial infarction or clinically significant cardiac dysrhythmia.
•5\. Uncontrolled hypertension
•6\. Taking medication known to cause serious interaction with CsA where the interaction cannot be prevented by monitoring and adjusting CsA level
•7\. Fludarabine refractory disease (Non response to or relapse within 6 months of fludarabine containing regimen)
•8\. Previous bone marrow transplant
•9\. History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years.
•10\. Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)