Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01622439
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Valcuria
Information provided by (Responsible Party):
Lund University Hospital

Tracking Information
First Submitted Date  ICMJE June 12, 2012
First Posted Date  ICMJE June 19, 2012
Last Update Posted Date March 12, 2018
Study Start Date  ICMJE June 2012
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2012)
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). ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma
Official Title  ICMJE Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B-cell Lymphoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Single, open labeld.
Interventions:
  • Drug: Valproate
  • Drug: Rituximab
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin
  • Drug: Vincristine
  • Drug: Prednisone
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2012)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01622439
Other Study ID Numbers  ICMJE Version1.1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lund University Hospital
Study Sponsor  ICMJE Lund University Hospital
Collaborators  ICMJE Valcuria
Investigators  ICMJE
Principal Investigator: Mats Jerkeman, MD, PhD Skåne University Hospital, Dept. of Oncology
PRS Account Lund University Hospital
Verification Date September 2016

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