Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma
Phase 1
Completed
- Conditions
- Diffuse Large B-cell Lymphoma
- Interventions
- Registration Number
- NCT01622439
- Lead Sponsor
- Lund University Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single, open labeld. Rituximab - Single, open labeld. Valproate - Single, open labeld. Cyclophosphamide - Single, open labeld. Doxorubicin - Single, open labeld. Vincristine - Single, open labeld. Prednisone -
- Primary Outcome Measures
Name Time Method Establishment of maximum tolerable dose of valproate. 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Skåne University Hospital, Dept. of Oncology
🇸🇪Lund, Sweden
Skåne University Hospital, Dept. of Oncology🇸🇪Lund, Sweden