Relapsed Diffuse Large B-Cell Lymphoma
Conditions
Interventions
Product Name: suberoylanilide hydroxamic acid (SAHA)
Product Code: MK-0683/L-001079038
Pharmaceutical Form: Capsule*
Sponsors
Merck Sharp & Dohme Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients must be =18 years with relapsed DLBCL (de novo or transformed)following standard first line chemotherapy and at least one salvage systemic therapy. Patients who have disease that is refractory to their last chemotherapy regimen are not eligible. Other eligibility criteria include: 3 months or longer without evidence of progression on the most recent treatment; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2; = 4 weeks from prior chemotherapy, radiation therapy, major surgery, or other investigational anticancer therapy; and adequate hematologic (absolute neutrophil count >1000/mm3, platelets > 75,000 /mm3), hepatic and renal function. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients to be excluded from the trial if: had prior treatment with any HDAC inhibitor (e.g., Depsipeptide, MS-275, LAQ 824); had a response or stable disease less than 3 m to the most recent treatment; have failed more than 3 prior regimens ; have had an allogenenic transplantation. have certain co-mobility including HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the anti-tumor effectiveness of oral suberoylanilide hydroxamic acid (SAHA) as measured by overall objective response rate (ORR) in patients with relapsed DLBCL (de novo or transformed).;Secondary Objective: To assess response duration (RD), progression-free survival time (PFS), time to progression, time to response, and progression free survival rate at 3 months and 6 months; and to assess the safety of oral SAHA in this patient population.;Primary end point(s): The primary efficacy endpoint is ORR based on PET and CT scan findings in patients with measurable disease defined as those that can be accurately measured in at least one dimension of ?2 cm by conventional CT scan. | — |
Countries
United Kingdom
Outcome results
None listed