Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma (VALFRID)
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| ClinicalTrials.gov Identifier: NCT01622439 |
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Recruitment Status :
Completed
First Posted : June 19, 2012
Last Update Posted : March 12, 2018
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Sponsor:
Lund University Hospital
Collaborator:
Valcuria
Information provided by (Responsible Party):
Lund University Hospital
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diffuse Large B-cell Lymphoma | Drug: Valproate Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma |
| Study Start Date : | June 2012 |
| Actual Primary Completion Date : | March 2018 |
| Actual Study Completion Date : | March 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
| Arm | Intervention/treatment |
|---|---|
| Experimental: Single, open labeld. |
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. |
Primary Outcome Measures :
- 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). ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622439
Locations
| Sweden | |
| Skåne University Hospital, Dept. of Oncology | |
| Lund, Sweden, 221 85 | |
Sponsors and Collaborators
Lund University Hospital
Valcuria
Investigators
| Principal Investigator: | Mats Jerkeman, MD, PhD | Skåne University Hospital, Dept. of Oncology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Lund University Hospital |
| ClinicalTrials.gov Identifier: | NCT01622439 |
| Other Study ID Numbers: |
Version1.1 |
| First Posted: | June 19, 2012 Key Record Dates |
| Last Update Posted: | March 12, 2018 |
| Last Verified: | September 2016 |
Keywords provided by Lund University Hospital:
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Lymphoma Diffuse large B-cell lymphoma Valproate R-CHOP CD 20 |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Prednisone Cyclophosphamide Rituximab Doxorubicin Vincristine |
Valproic Acid Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |