A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients with Relapsed Diffuse Large B-Cell Lymphoma (DLBCL) - L-001079038 in Relapsed DLBC
- Conditions
- Relapsed Diffuse Large B-Cell Lymphoma
- Registration Number
- EUCTR2004-001907-36-GB
- Lead Sponsor
- Merck Sharp & Dohme Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method