Back to resultsPretreatment With Valproate Prior to Immunotherapy Targeting Cluster of Differentiation Antigen 20 in Chronic Lymphocytic Leukemia (PREVAIL)
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Completed
Phase
Early Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Valproate
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Chronic Lymphocytic Leukemia, Valproate, Cluster of differentiation antigen 20, Lymphomas, B-cell lymphomas, Translational research, Monoclonal antibodies
Eligibility 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
Sites / Locations
- Lund University Hospital, Department of Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Valproate
Arm Description
Outcomes
Primary Outcome Measures
Levels of CD20 protein and messengerRNA in response to treatment with valproate in patients with chronic lymphatic leukemia.
Secondary Outcome Measures
Translational blood samples.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02144623
Brief Title
Pretreatment With Valproate Prior to Immunotherapy Targeting Cluster of Differentiation Antigen 20 in Chronic Lymphocytic Leukemia
Acronym
PREVAIL
Official Title
Pretreatment With Valproate Prior to Immunotherapy Targeting Cluster of Differentiation Antigen 20 in Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
Chronic Lymphocytic Leukemia, Valproate, Cluster of differentiation antigen 20, Lymphomas, B-cell lymphomas, Translational research, Monoclonal antibodies
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valproate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Valproate
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Drott, MD, PhD
Organizational Affiliation
Lund University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University Hospital, Department of Oncology
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Pretreatment With Valproate Prior to Immunotherapy Targeting Cluster of Differentiation Antigen 20 in Chronic Lymphocytic Leukemia
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