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Completed

NCT Number: NCT01255644

Antiviral Treatment of Chronic Lymphocytic Leukemia

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valganciclovir

Drug

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

Other names: Valcyte

Primary outcomes

  1. Leukocyte count

    Time frame: Month 12

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: VGCV-CLL

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Dec 7, 2010
Registry last updated
Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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