Overview

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

Status:
Completed
Trial end date:
2018-03-01
Target enrollment:
0
Participant gender:
All
Summary
Patients with previously untreated diffuse large B-cell lymphoma will receive standard treatment with R-CHOP (rituximab,cyclosphosphamide, doxorubicin, vincristine, and prednison) for 6 cycles, cycle length is 14 or 21 days. In addition, valproate is given three times daily day 1-3 in escalated doses. The rationale for adding valproate to standard treatment is invitro data indicating a sensitizing effect to chemotherapy, and an increase in CD 20-expression. Patients are included in 3+3 cohorts with escalation of valproate dose, planned dos levels are 30, 60, 80, 100, 120, 140 mg/kg/day. A total of 20 patients will be treated at the MTD.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lund University Hospital
Collaborator:
Valcuria
Treatments:
Cyclophosphamide
Doxorubicin
Prednisone
Rituximab
Valproic Acid
Vincristine
Criteria
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
treatment

- 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