An early phase trial of Cyclosporin A in patients with early stage Chronic Lymphocytic Leukaemia (CLL) who do not currently require treatment.

Phase 1

• Conditions: Chronic Lymphocytic Leukaemia; MedDRA version: 17.0 Level: LLT Classification code 10068919 Term: B-cell chronic lymphocytic leukemia System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002795-13-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-24
• Study Completion: 2016-04-04
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

• Stage A or B CLL (Binet system) not requiring therapy by conventional criteria
• = 2 lines of previous therapy for CLL
• Age =18
• ECOG performance status =2
• Life expectancy >12 months
• No therapy for CLL in previous 3 months (including glucocorticoids)
• CD38+ve; = 7%
• Normal renal function (eGFR >60mls/min)
• Normal liver function (AST and / or ALT <1.5 ULN)
• Negative serology for Hepatitis B, C and HIV
• Valid informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

• Active infection
• Active autoimmune disease (requiring therapy)
• Diabetes Mellitus
• Previous myocardial infarction or history of cardiac dysrhythmia.
• Uncontrolled hypertension
• Taking medication known to cause serious interaction with CsA where the interaction cannot be prevented by monitoring and adjusting CsA level
• Fludarabine refractory disease (Non response to or relapse within 6 months of fludarabine containing regimen)
• Previous bone marrow transplant
• 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.
• Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)
• Patients and partners of childbearing potential not willing to use effective contraception during and for 3 months after therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified