Antiviral Treatment of Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

— VGCV-CLL  

Official title:

Treatment of Chronic Lymphocytic Leukemia With the Use of an Antiviral Compound - a Proof of Principle Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255644
• Other study ID #: EudraCT_2010-021786-78
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2010
• Last updated: July 20, 2015
• Start date: December 2010
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

Chronic lymphocytic leukemia (CLL) is increasingly believed to be closely related to chronic stimulation of healthy B-cells. Identification of antigen(s) are relevant for the stimulation of CLL precursor cells is therefore of high interest. The investigators found recently evidence that a herpes virus is involved in this process of stimulation. Consequently, elimination of the antigenic stimulation of leukemic cells by this herpes virus may be expected to reduce or even inhibit propagation of leukemic cells. The investigators hypothesize that inhibition of CMV replication by a short course of antiviral treatment may reduce significantly proliferation rates of leukemic cells. To test this hypothesis, the investigators will treat 20 CLL patients with an antiviral drug for 3 months in a proof-of-concept clinical trial and leukemic cell counts measured before and after antiviral treatment. Antiviral treatment has the potential to treat the disease at its origin and therefore more efficiently than conventional chemotherapeutic regimens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CLL confirmed by immunophenotyping and a relative preponderance of leukemic cells of >70%

• ANC >1.500 /µl, Thrombocyte count >100.000 /µl und hemoglobin value >11 g/dl

• CLL patients with expression of immunoglobulin heavy chains (IGHV) 1-69 or 3-21

• Seropositive for CMV-specific IgG-antibodies

• Older than 18 years of age

• Written informed consent

• Able to comply with the protocol

• If female, should not be pregnant or be breast-feeding. Women of child-bearing age must have a negative serum pregnancy test within 28days prior to enrollment into the study, if a serum pregnancy test is not performed within 7 days prior first IMP administration; a confirmatory urine test is required.

Exclusion Criteria:

• Indications for treatment of CLL (advanced stages of the disease)

• Having receiving chemotherapy for CLL within 3 months prior to enrollment

• Having received antiviral drugs or i.v. immunoglobulins within 3 months prior to enrollment

• Significant thrombocytopenia (<100.000/µl) or anemia (Hb < 11 g/dl)

• Women of child bearing age not using effective contraception

• Pregnant of lactating female (as determined by a positive pregnancy test at screening or within 7 days prior to first IMP administration)

• Known hypersensitivity to drug or its excipients

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Valganciclovir
900 mg every 24 hours per os, day 1 through 90

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Steininger C, Rassenti LZ, Vanura K, Eigenberger K, Jäger U, Kipps TJ, Mannhalter C, Stilgenbauer S, Popow-Kraupp T. Relative seroprevalence of human herpes viruses in patients with chronic lymphocytic leukaemia. Eur J Clin Invest. 2009 Jun;39(6):497-506. doi: 10.1111/j.1365-2362.2009.02131.x. — View Citation

Vanura K, Le T, Esterbauer H, Späth F, Porpaczy E, Shehata M, Eigenberger K, Hauswirth A, Skrabs C, Krömer E, Schwarzinger I, Streubel B, Steininger C, Fonatsch C, Stilgenbauer S, Wagner O, Gaiger A, Jäger U. Autoimmune conditions and chronic infections in chronic lymphocytic leukemia patients at diagnosis are associated with unmutated IgVH genes. Haematologica. 2008 Dec;93(12):1912-6. doi: 10.3324/haematol.12955. Epub 2008 Oct 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leukocyte count		Month 12	No