Treatment of blood cancer with the use of a drug active against herpesviruses

Phase 1

Conditions: Chronic lymphocytic leukemia
MedDRA version: 14.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2010-021786-78-AT

Lead Sponsor: Medizinische Universität Wien

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•CLL confirmed by immunophenotyping and a relative preponderance of leukemic cells of >70%
•CLL patients with expression of immunoglobuline heavy chains (IGHV) 1-69 or 3-21
•Seropositive for CMV-specific IgG-antibodies

Are the trial subjects under 18? no
Number of subjects for this age range:
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 15

Exclusion Criteria

CLL patients who received treatment for their disease, i.v. immunoglobulines, or anti-CMV treatment within 3 months prior to enrollment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the response of CLL patients to a three months course of antiviral prophylaxis as measured by the kinetics of the absolute lymphocyte count of CLL patients;Secondary Objective: Cytomegalovirus shedding in urine and evidence of viral replication in plasma samples before, during, and after antiviral prophylaxis as parameter for the successful use of the antiviral compounds;Primary end point(s): Relative change in lymphocyte counts before and after treatment with VGCV;Timepoint(s) of evaluation of this end point: Month 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Increases in thrombocyte count and haemoglobin value<br>Decrease in ß-2 microglobuline value in peripheral blood;Timepoint(s) of evaluation of this end point: Month 12