Antiviral Treatment of Chronic Lymphocytic Leukemia

NCT01255644 | Completed Phase 4 DMC

• 1 other identifier: EudraCT_2010-021786-78
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Leukocyte count

  Month 12

Study Arms (1)

Antiviral drug

EXPERIMENTAL

Drug: Valganciclovir

Interventions

Valganciclovir DRUG

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

Also known as: Valcyte

Antiviral drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

• 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.

  PMID: 19490058 BACKGROUND

• 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.

  PMID: 18838479 BACKGROUND

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Christoph Steininger, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

AU (1)