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NCT Number: NCT02144623

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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Lund University Hospital, Department of Oncology

Lund, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valproate

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Acronym: PREVAIL

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 22, 2014
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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