Pretreatment With Valproate Prior to Immunotherapy Targeting Cluster of Differentiation Antigen 20 in Chronic Lymphocytic Leukemia
Information source: Lund University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Lymphocytic Leukemia
Intervention: Valproate (Drug)
Phase: Phase 0
Status: Recruiting
Sponsored by: Lund University Hospital Official(s) and/or principal investigator(s):
Kristina Drott, MD, PhD, Principal Investigator, Affiliation: Lund University Hospital
Overall contact:
Kristina Drott, MD, PhD, Phone: +46 46 17 75 20, Email: kristina.drott@med.lu.se
Summary
This trial includes patients with chronic lymphocytic leukemia, the most common kind of
malignant lymphoma. Monoclonal antibodies directed against cluster of differentiation
antigen 20 have improved treatment results in different forms of lymphomas; however in
chronic lymphocytic leukemia treatment with monoclonal antibodies is less effective, and it
has been suggested that this is depending on a lower expression of the cluster of
differentiation antigen 20 protein on the chronic lymphocytic leukemia cells.
Valproate, an anticonvulsant drug, has been shown to increase the cluster of differentiation
antigen 20 expression, and the rationale in this study is that an increasement of cluster
of differentiation antigen 20 would make treatment with monoclonal antibodies in patients
with chronic lymphocytic leukemia more effective.
Clinical Details
Official title: Pretreatment With Valproate Prior to Immunotherapy Targeting Cluster of Differentiation Antigen 20 in Chronic Lymphocytic Leukemia
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Levels of CD20 protein and messengerRNA in response to treatment with valproate in patients with chronic lymphatic leukemia.
Secondary outcome: Translational blood samples.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 18-80 years
- Histologically confirmed chronic lymphocytic leukemia
- Leucocyte count more than 20 x 10 9/L
- No other simultaneous treatment for lymphoma
- No treatment indicated for chronic lymphocytic leukemia
- WHO performance status 0-2
- HIV negativity
- Negativity for hepatitis C virus , HBsAG, anti-hepatitis B core antigen, or other
active infection uncontrolled by treatment
- Agree to abstain from donating blood while taking study drug therapy and for one week
following discontinuation of study drug therapy
- Agree not to share study medication with another person and to return all unused
study drug to the investigator
- Written informed concent
Exclusion Criteria:
- Psychiatric illness or condition which could interfere with the subjects' ability to
understand the requirements of the study
- Neurological or neuropsychiatric disorder, interfering with the requirements of the
study
- Hearing impairment over grade 2
- Porphyria
- History of acute or chronic hepatitis
- Family history of severe drug-induced hepatitis
- Pregnancy and lactation
Locations and Contacts
Kristina Drott, MD, PhD, Phone: +46 46 17 75 20, Email: kristina.drott@med.lu.se
Lund University Hospital, Department of Oncology, Lund 221 85, Sweden; Recruiting
Jan Sundberg, RN, Phone: +46 46 17 70 34, Email: jan.sundberg@skane.se
Kristina Drott, MD, PhD, Principal Investigator
Additional Information
Starting date: January 2015
Last updated: April 10, 2015
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