Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma
VALFRID
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 12, 2012
CompletedFirst Posted
Study publicly available on registry
June 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedMarch 12, 2018
September 1, 2016
5.8 years
June 12, 2012
March 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Study Arms (1)
Single, open labeld.
EXPERIMENTALInterventions
Valproate is given in escalating doses to establish maximum tolerable dose when given together with standard treatment in patients with diffuse large B-cell lymphoma; this is the phase I part of the study. When maximum tolerable dose is established, this dose will be given to remaining patients in the phase II part of the study.
Vill be given intravenously, 375 mg/m2, every second or third week depending on cycle length (14 or 21 days), for a total of 6 cycles.
Vill be given intravenously, 750 mg/m2, every second or third week depending on cycle length (14 or 21 days) for a total of 6 cycles.
Vill be given intravenously, 50 mg/m2, every second or third week depending on cycle length (14 or 21 days), for a total of 6 cycles.
Vill be given intravenously, 1.2 mg/m2, every second or third week depending on cycle length (14 or 21 days), for a total of 6 cycles.
Vill be given orally, 50 mg/m2, day 1-5 every cycle, for a total of 6 cycles.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund University Hospitallead
- Valcuriacollaborator
Study Sites (1)
Skåne University Hospital, Dept. of Oncology
Lund, 221 85, Sweden
Related Publications (1)
Drott K, Hagberg H, Papworth K, Relander T, Jerkeman M. Valproate in combination with rituximab and CHOP as first-line therapy in diffuse large B-cell lymphoma (VALFRID). Blood Adv. 2018 Jun 26;2(12):1386-1392. doi: 10.1182/bloodadvances.2018019240.
PMID: 29903707DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mats Jerkeman, MD, PhD
Skåne University Hospital, Dept. of Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2012
First Posted
June 19, 2012
Study Start
June 1, 2012
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
March 12, 2018
Record last verified: 2016-09