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:
Participant gender:
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.