Antiviral Treatment of Chronic Lymphocytic Leukemia (VGCV-CLL)

Medical University of Vienna

Status and phase

Completed

Phase 4

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: Valganciclovir

Study type

Interventional

Funder types

Other

Identifiers

NCT01255644

EudraCT_2010-021786-78

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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