Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Inclusion Criteria

• Histological or cytological diagnosis of the following peripheral T-cell lymphoma (PTCL) subtypes as defined by the WHO classification (2008) may be included:
• PTCL, NOS
• Angioimmunoblastic T-cell lymphoma (AITL)
• Anaplastic large-cell lymphoma (ALCL), ALK+
• Anaplastic large-cell lymphoma (ALCL), ALK-
• Enteropathy-associated T-cell lymphoma (EATL)
• Hepatosplenic T-cell lymphoma
• Subcutaneous panniculitis-like T-cell lymphoma
• Patients for whom at least 1 measurable lesion is confirmed by the lesion assessment at baseline; an evaluable lesion is defined as more than 1.5 cm in greatest dimension and can be followed by imaging.
• Relapsed or refractory disease after receiving ≥1 prior systemic therapy with antitumor agent(s) and there is no other available treatment which can be considered appropriate for patients. Systemic therapy is defined as frontline chemotherapy or immunotherapy administered systemically.
• Male or female, age 20 years or older
• ECOG Performance Status of 0-2
• Life expectancy of greater than 3 months
• Meeting the following laboratory criteria for screening:
• Absolute Neutrophil Count >1500/µL independent of growth factor support within 7 days of starting the study drug
• Platelets >75, 000/µL independent of transfusion within 14 days of starting the study drug
• Hgb >8 g/dL independent of transfusion within 14 days of starting the study drug
• Serum creatinine 450 msec at screening, female patients with QTcF > 470 msec at screening or patients with congenital long QT syndrome, clinically significant arrhythmia, history of congestive heart failure (New York Heart Association Class III or IV) or acute myocardial infarction within 6 months of starting the study drug
• Patients with known hypersensitivity to benzamide class of compounds or any of the components of HBI-8000 tablets, and patients with prior exposure of HBI-8000
• Patients with a history of second malignancy other than disease under study. The exceptions are disease that has been treated with curative intent with no evidence of recurrence in past 2 years including:
• Basal cell carcinoma of the skin
• Squamous cell carcinoma of the skin
• Cervical carcinoma in situ
• Carcinoma in situ of the breast
• An incidental histological finding of prostate carcinoma (TNM stage T1a or T1b)
• Early-stage gastric cancer treated with endoscopic mucosal resection or endoscopic submucosal dissection
• Thyroid cancer with differentiated histology (e.g. papillary) treated with curative intent
• Autologous stem cell transplantation within 12 weeks (84 days) of starting the study drug
• History of allogeneic stem cell transplantation
• Organ transplantation recipients except autologous hematopoietic stem cell transplantation
• Uncontrolled inter-current infection
• Hepatitis B surface antigen-positive, or hepatitis C virus antibody positive. In case hepatitis B core antibody and/or hepatitis B surface antibody is positive even if hepatitis B surface antigen-negative, a hepatitis B virus DNA test (real-time PCR measurement) should be performed and if positive, the patient should be excluded from study
• Any history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
• Uncontrolled diabetes mellitus, hypertension, endocrine disorder, bleeding disorder
• Major surgery or radiation therapy within 28 days of starting the study drug
• Receiving investigational agents or anti-cancer therapy, within 28 days, nitrosourea or mitomycin C within 42 days of starting the study drug
• Receiving antibody therapy for PTCL within 12 weeks of starting the study drug
• Women who are breastfeeding or women who are not willing to stop breastfeeding during study treatment period and for 30 days after the last dose of study drug
• Potential for non-compliance or at increased risk based on investigator's judgement