NCT02144623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2015

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2017

Completed
Last Updated

March 3, 2017

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

May 15, 2014

Last Update Submit

March 1, 2017

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic LeukemiaValproateCluster of differentiation antigen 20LymphomasB-cell lymphomasTranslational researchMonoclonal antibodies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Other Outcomes (1)

  • 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.

Study Arms (1)

Valproate

EXPERIMENTAL
Drug: Valproate

Interventions

ValproateDRUG
Valproate

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University Hospital, Department of Oncology

Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLymphomaLymphoma, B-Cell

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Kristina Drott, MD, PhD

    Lund University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2014

First Posted

May 22, 2014

Study Start

January 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 6, 2017

Last Updated

March 3, 2017

Record last verified: 2016-09

Locations

SE(1)