An Early Phase 1 interventional study of Valproate in Chronic Lymphocytic Leukemia, sponsored by Lund University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by Lund University Hospital · Early Phase 1, Interventional, and Treatment
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 4 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Lund University Hospital is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Drug: Valproate
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.
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.
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.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Lund University Hospital