Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Samsung Medical Center
With
Seok Jin Kim
1. Objectives 1.1 Primary objective • To determine the efficacy of vorinostat plus FND as an induction treatment
* Response rate of vorinostat/FND 1.2 Secondary objective
* Survival outcome
* Overall survival and progression-free survival
* To determine the efficacy of vorinostat maintenance treatment
* Relapse rate • Toxicity of vorinostat/FND
* Hematologic and non-hematologic toxicity
Age
19–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Inclusion
* Histologically proven mantle cell lymphoma
* Adequate organ function as defined by the following criteria:
* Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
* Total serum bilirubin ≤1.5 x ULN
* Absolute neutrophil count (ANC) ≥1500/µL
* Platelets ≥100,000/µL
* Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated)
* Serum calcium ≤12.0 mg/dL
* Serum creatinine ≤1.5 x ULN
* Normal potassium and magnesium at baseline
* All patients should be relapsed or refractory patients after previous treatments including chemotherapy .
* At least one measurable lesion (lymph node or tumor mass)
\- The size of lesion must be \> 1.0cm in the greatest transverse diameter
* ECOG PS 0-2
* Serum HCG test: negative if a patient is female eligible for pregnancy
2. Exclusion
* Major surgery or radiation therapy within 4 weeks of starting the study treatment.
* History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease or secondary CNS involvement on CT or MRI scan.
* Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.
* Pregnancy or breastfeeding.
* Patients with HIV positive
* Patients with HBs antigen positive
* Patients with anti-HCV positive
* History of the use of another HDAC inhibitor: e.g. valproic acid
Clareo Health | Vorinostat Plus FND in Relapsed or Refractory Mantle Cell Lymphoma
