Skip to main content
OpenTrials
Completed

NCT Number: NCT01622439

Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Skåne University Hospital, Dept. of Oncology

Lund, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valproate

Drug

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.

Rituximab

Drug

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.

Cyclophosphamide

Drug

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.

Doxorubicin

Drug

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.

Vincristine

Drug

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.

Prednisone

Drug

Vill be given orally, 50 mg/m2, day 1-5 every cycle, for a total of 6 cycles.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Collaborators

  • Valcuria

Registry information

Acronym: VALFRID

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jun 19, 2012
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.