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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

Page last updated: August 20, 2015

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