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

Treatment of chronic lymphocytic leukemia with the use of an antiviral compound - a proof of principle study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021786-78-AT

Enrollment

Unknown

Registered

2010-09-07

Start date

2010-11-11

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic lymphocytic leukemia MedDRA version: 14.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Valcyte (Valganciclovir) Product Name: Valcyte Product Code: C31704 Pharmaceutical Form: Coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): Increases in thrombocyte count and haemoglobin value Decrease in ß-2 microglobuline value in peripheral blood;Timepoint(s) of evaluation of this end point: Month 12	—

Countries

Austria

Contacts

Public ContactDepartment of Medicine I

Medical University of Vienna

christoph.steininger@meduniwien.ac.at00431404004440

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026