drugset / Trial / NCT01622439
Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2012-06
- Primary completion
- 2018-03
- Completion
- 2018-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Valproate | Small molecule | 30 mg/kg | — |
| Subject | Valproate | Small molecule | 60 mg/kg | — |
| Subject | Valproate | Small molecule | 80 mg/kg | — |
| Subject | Valproate | Small molecule | 100 mg/kg | — |
| Subject | Valproate | Small molecule | 120 mg/kg | — |
| Subject | Valproate | Small molecule | 140 mg/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 50 mg/m2 | Oral |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Vincristine | Small molecule | 1.2 mg/m2 | Intravenous |