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Antiviral Treatment of Chronic Lymphocytic Leukemia (VGCV-CLL)

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Valganciclovir
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Antiviral drug

Arm Description

Outcomes

Primary Outcome Measures

Leukocyte count

Secondary Outcome Measures

Full Information

First Posted
December 6, 2010
Last Updated
July 20, 2015
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01255644
Brief Title
Antiviral Treatment of Chronic Lymphocytic Leukemia
Acronym
VGCV-CLL
Official Title
Treatment of Chronic Lymphocytic Leukemia With the Use of an Antiviral Compound - a Proof of Principle Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antiviral drug
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Valganciclovir
Other Intervention Name(s)
Valcyte
Intervention Description
900 mg every 24 hours per os, day 1 through 90
Primary Outcome Measure Information:
Title
Leukocyte count
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Steininger, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
19490058
Citation
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.
Results Reference
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PubMed Identifier
18838479
Citation
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.
Results Reference
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Antiviral Treatment of Chronic Lymphocytic Leukemia

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