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

Not Applicable

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Leukaemia (chronic); Cancer; Chronic lymphocytic leukaemia of B-cell type

• Registration Number: ISRCTN61297219
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-05
• Study Completion: 2015-04-29
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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
11. Valid informed consent

Exclusion Criteria

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)
11. Patients and partners of childbearing potential not willing to use effective contraception during and for 3 months after therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in proliferation rate of CLL cells; Timepoint(s): Change in proliferation rate of CLL cells after 4 weeks of CsA therapy, measured by deuterated glucose

Secondary Outcome Measures

Name	Time	Method
<br> 1. Complete response rate<br> 2. Complete Remission after 8 weeks and 6 months<br> 3. CsA Loss of labelled CLL cells; Timepoint(s): Rate of loss of labelled CLL cells from the circulation with CsA therapy<br> 4. Overall response rate; Timepoint(s): Overall response rate (Complete Remission + Partial Remission) after 8 weeks and 6 months of CsA<br> 5. Release of labelled CLL cells; Timepoint(s): Time to maximum release of labelled CLL cells into the circulation with CsA therapy<br> 6. Spontaneous intra-patient variation; Timepoint(s): Spontaneous intra-patient variation in the proliferation, release and loss of CLL cells from the cirulation<br> 7. Toxicity of CsA in patients with CLL; Timepoint(s): Toxicity of CsA in patients with CLL (toxicities will be measured and graded according to CTCAE criteria<br>