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
>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