Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma
This trial is active, not recruiting.
|Condition||diffuse large b-cell lymphoma|
|Treatments||valproate, rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone|
|Phase||phase 1/phase 2|
|Sponsor||Lund University Hospital|
|Start date||June 2012|
|End date||December 2016|
|Trial size||50 participants|
|Trial identifier||NCT01622439, Version1.1|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Establishment of maximum tolerable dose of valproate.
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).
Male or female participants from 18 years up to 80 years old.
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
|Official title||Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma|
|Principal investigator||Mats Jerkeman, MD, PhD|
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