Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma
Information source: Lund University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diffuse Large B-cell Lymphoma
Intervention: Valproate (Drug); Rituximab (Drug); Cyclophosphamide (Drug); Doxorubicin (Drug); Vincristine (Drug); Prednisone (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Lund University Hospital Official(s) and/or principal investigator(s):
Mats Jerkeman, MD, PhD, Principal Investigator, Affiliation: Skåne University Hospital, Dept. of Oncology
Overall contact:
Mats Jerkeman, MD, PhD, Phone: +46 46 17 75 20, Email: mats.jerkeman@med.lu.se
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.
Clinical Details
Official title: Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Establishment of maximum tolerable dose of valproate.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Mats Jerkeman, MD, PhD, Phone: +46 46 17 75 20, Email: mats.jerkeman@med.lu.se
Skåne University Hospital, Dept. of Oncology, Lund 221 85, Sweden; Recruiting
Mats Jerkeman, MD, PhD
Additional Information
Starting date: June 2012
Last updated: May 26, 2015
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