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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02144623
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Valproate Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pretreatment With Valproate Prior to Immunotherapy Targeting Cluster of Differentiation Antigen 20 in Chronic Lymphocytic Leukemia
Study Start Date : January 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 6, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Valproate Drug: Valproate


Outcome Measures
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Primary Outcome Measures :
  1. Levels of CD20 protein and messengerRNA in response to treatment with valproate in patients with chronic lymphatic leukemia. [ Time Frame: 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 :
  1. Translational blood samples. [ Time Frame: 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. ]

Other Outcome Measures:
  1. Number of patients with adverse events as a measure of safety and tolerability. [ Time Frame: During treatment period (6 weeks) and 4 weeks post treatment, in total 10 weeks. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144623


Locations
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Sweden
Lund University Hospital, Department of Oncology
Lund, Sweden, 221 85
Sponsors and Collaborators
Lund University Hospital
Investigators
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Principal Investigator: Kristina Drott, MD, PhD Lund University Hospital
More Information
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Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT02144623    
Other Study ID Numbers: Version 1.2
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: September 2016
Keywords provided by Lund University Hospital:
Chronic Lymphocytic Leukemia
Valproate
Cluster of differentiation antigen 20
Lymphomas
 B-cell lymphomas
Translational research
Monoclonal antibodies
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
 Pathologic Processes
Valproic Acid
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs