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Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma

Phase 1/Phase 2
18 Years
80 Years
Open (Enrolling)
Diffuse Large B-cell Lymphoma

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Trial Information

Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma

Inclusion Criteria:

- Age 18-80 years

- Histologically confirmed (according to the WHO classification) diffuse large B-cell
lymphoma stage II-IV

- No previous treatment for lymphoma. Corticosteroids for alleviation of lymphoma
associated symptoms are allowed

- WHO performance status 0-2

- HIV negativity

- Seronegativity for HCV, HBsAg, anti-HBc, or other active infection uncontrolled by

- Absence of psychiatric illness or condition which could interfere with the subjects
ability understand the requirements of the study

- Absence of neurological or neuropsychiatric disorder, interfering with the
requirements of the study

- Absence of hearing impairment > grade 2

- Absence of porphyria

- In females: absence of pregnancy and lactation

- All subjects must agree to abstain from donating blood while taking study drug
therapy and for one week following discontinuation of study drug therapy

- All subjects must agree not to share study medication with another person, and to
return all unused study drug to investigators

- Written informed concent according to ICH/GCP and Swedish regulations

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establishment of maximum tolerable dose of valproate.

Outcome Time Frame:

Participating patients will be followed during study treatment (6 cycles of chemotherapy); 12 weeks or 18 weeks depending on cycle length (14 or 21 days).

Safety Issue:


Principal Investigator

Mats Jerkeman, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Skåne University Hospital, Dept. of Oncology


Sweden: Medical Products Agency

Study ID:




Start Date:

June 2012

Completion Date:

February 2014

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Lymphoma
  • Diffuse large B-cell lymphoma
  • Valproate
  • R-CHOP
  • CD 20
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse