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

Chronic Lymphocytic Leukemia Clinical Trial

— PREVAIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144623
• Other study ID #: Version 1.2
• Status: Completed
• Phase: Early Phase 1
• First received: May 15, 2014
• Last updated: March 1, 2017
• Start date: January 2015
• Est. completion date: February 6, 2017

Study information

• Verified date: September 2016
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: February 6, 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Valproate

Locations

Country	Name	City	State
Sweden	Lund University Hospital, Department of Oncology	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with adverse events as a measure of safety and tolerability.		During treatment period (6 weeks) and 4 weeks post treatment, in total 10 weeks.
Primary	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	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.