Status:
COMPLETED
Antiviral Treatment of Chronic Lymphocytic Leukemia
Lead Sponsor:
Medical University of Vienna
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 precur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01255644
Start Date
December 1 2010
End Date
July 1 2015
Last Update
July 21 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Vienna
Vienna, Austria, 1090