Pretreatment With Valproate Prior to Immunotherapy Targeting Cluster of Differentiation Antigen 20 in Chronic Lymphocytic Leukemia

Early Phase 1

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: Valproate

• Registration Number: NCT02144623
• Lead Sponsor: Lund University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-22
• Study Start: 2015-01
• Primary Completion: 2016-02
• Status Verified: 2016-09
• Study Completion: 2017-02-06
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valproate	Valproate	-

Primary Outcome Measures

Name	Time	Method
Levels of CD20 protein and messengerRNA in response to treatment with valproate in patients with chronic lymphatic leukemia.	Blood samples to determine the level of CD20 and messengerRNA are taken day 1 and 4 at each cycle; 3 cycles are given with a cycle length of 21 days. Valproate concentration are taken day 1, 2, 3 and 4 at each cycle.

Secondary Outcome Measures

Name	Time	Method
Translational blood samples.	Blood tests for translational studies of the epigenetic and transcriptional regulation of the CD20 promotor are taken prestudy, day 1, 2, 3 and 4 at each cycle and 3 months post treatment.

Trial Locations

Locations (1)

Lund University Hospital, Department of Oncology; 🇸🇪 Lund, Sweden