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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Lund University Hospital
Sponsor:
Collaborator:
Valcuria
Information provided by (Responsible Party):
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT01622439
First received: June 12, 2012
Last updated: April 25, 2014
Last verified: April 2014

June 12, 2012
April 25, 2014
June 2012
December 2014   (final data collection date for primary outcome measure)
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). ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01622439 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma
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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diffuse Large B-cell Lymphoma
  • Drug: Valproate
    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.
  • Drug: Rituximab
    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.
  • Drug: Cyclophosphamide
    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.
  • Drug: Doxorubicin
    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.
  • Drug: Vincristine
    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.
  • Drug: Prednisone
    Vill be given orally, 50 mg/m2, day 1-5 every cycle, for a total of 6 cycles.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Mats Jerkeman, MD, PhD +46 46 17 75 20 mats.jerkeman@med.lu.se
Sweden
 
NCT01622439
Version1.1
No
Lund University Hospital
Lund University Hospital
Valcuria
Principal Investigator: Mats Jerkeman, MD, PhD Skåne University Hospital, Dept. of Oncology
Lund University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP