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Antiviral Treatment of Chronic Lymphocytic Leukemia (VGCV-CLL)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01255644
First received: December 6, 2010
Last updated: July 29, 2011
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
 Drug: Valganciclovir
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Chronic Lymphocytic Leukemia With the Use of an Antiviral Compound - a Proof of Principle Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Leukocyte count [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antiviral drug Drug: Valganciclovir
900 mg every 24 hours per os, day 1 through 90
Other Name: Valcyte

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255644

Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Christoph Steininger, MD Medical University of Vienna
  More Information

Publications:

Responsible Party: Priv.-Doz. Dr. C. Steininger, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01255644     History of Changes
Other Study ID Numbers: EudraCT_2010-021786-78
Study First Received: December 6, 2010
Last Updated: July 29, 2011
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Antiviral Agents
Valganciclovir
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013