DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017