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

Phase 4
18 Years
Open (Enrolling by invite only)
Chronic Lymphocytic Leukemia

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Trial Information

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

Inclusion Criteria:

- CLL confirmed by immunophenotyping and a relative preponderance of leukemic cells of

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Leukocyte count

Outcome Time Frame:

Month 12

Safety Issue:


Principal Investigator

Christoph Steininger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Vienna


Austria: Federal Office for Safety in Health Care

Study ID:




Start Date:

December 2010

Completion Date:

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid