Antiviral Treatment of Chronic Lymphocytic Leukemia

NCT ID: NCT01255644

Last Updated: 2015-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-07-31

Brief 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.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antiviral drug

Group Type: EXPERIMENTAL

Valganciclovir

Intervention Type: DRUG

900 mg every 24 hours per os, day 1 through 90

Interventions

Valganciclovir

900 mg every 24 hours per os, day 1 through 90

Intervention Type: DRUG

Other Intervention Names

Valcyte

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dr. Christoph Steininger

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph Steininger, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

Steininger C, Rassenti LZ, Vanura K, Eigenberger K, Jager 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.

Reference Type: BACKGROUND

PMID: 19490058 (View on PubMed)

Vanura K, Le T, Esterbauer H, Spath F, Porpaczy E, Shehata M, Eigenberger K, Hauswirth A, Skrabs C, Kromer E, Schwarzinger I, Streubel B, Steininger C, Fonatsch C, Stilgenbauer S, Wagner O, Gaiger A, Jager 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.

Reference Type: BACKGROUND

PMID: 18838479 (View on PubMed)

Other Identifiers

EudraCT_2010-021786-78

Identifier Type: -

Identifier Source: org_study_id