NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	recurrent/refractory peripheral T-cell lymphoma
Date of first enrollment	12/10/2012
Target sample size	49
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : forodesine INN of investigational material : forodesine Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : oral administration of forodesine 300 mg twice daily

Outcome(s)

Primary Outcome	Objective response rate
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	#Patients histologically diagnosed with peripheral T-cell lymphoma by pathological diagnosis of biopsied lesion. #Recurrent/refractory patients with a treatment history of at least one regimen, and who achieved at least a partial response to the latest treatment with an antineoplastic drug. #Patients with an enlarged lymph node or extranodal mass lesion clearly measurable in two perpendicular directions and greater than 1.5 cm in maximum diameter on computed tomography performed. #Patients expected to survive for at least 3 months. #ECOG PS 0-1. #Patients with adequate organ function. #Patients from whom written consent has been obtained prior to study initiation.
Exclude criteria	#Patients who received a chemotherapy agent or a high dose of a systemic adrenocorticosteroid within 21 days prior to initial administration of the study drug. #Patients who received radiation therapy, phototherapy, or electron beam therapy within 21 days prior to initial administration of the study drug. #Patients who received another study drug within 28 days prior to initial administration of the study drug. #Patients who received antibody therapy within 100 days prior to initial administration of the study drug. #Patients with a history of allogeneic hematopoietic stem cell transplantation. Or patients with a history of autologous hematopoietic stem cell transplantation within 100 days prior to initial administration of the study drug. #Patients with cerebral metastasis or central nervous system lesion or a past history. #Patients with active multiple primary cancer. Or patients with a history of a malignant neoplasm other than peripheral T-cell lymphoma within the past 5 years. #Patients with severe cardiovascular disease. #Patients with congenital long QT syndrome. #Patients with QTcF >0.48 sec. #Patients positive for HBs antigen, HCV antibody or HIV antibody on immunological investigation. Or patients positive for either HBc antibody or HBs antibody, and showing DNA more than sensitivity in HBV-DNA assay. #Patients positive for CMV antigen on immunological investigation. #Patients with infectious disease requiring treatment consisting of intravenous administration of antibacterial agent, fungicide, or antiviral drug. #Patients with interstitial pneumonia or pulmonary fibrosis, or patients judged to have insufficient pulmonary function.