Safety and Efficacy Study of TNX-650 to Treat Refractory Hodgkin’s Lymphoma

Inclusion Criteria:

Histological diagnosis of relapsed or refractory classical HL
Age >18 years
Received and failed potentially curative chemotherapeutic regimens (e.g., ABVD, Stanford V, or BEACOPP)
Relapsed following autologous bone marrow transplantation (BMT), or are ineligible, or refused BMT
Completed radiotherapy, chemotherapy, and/or treatment with other investigational agents at least 3 weeks prior to study entry
Completed autologous BMT (if received) at least 3 months prior to study entry; completed allogeneic BMT (if received); at least 6 months prior to study entry
Eastern Cooperative Oncology Group (ECOG) status of <2
Life expectancy of >3 months

Laboratory data:

Platelet count >50,000/mm3
Hemoglobin >9.0 g/dL (may be maintained by transfusion)
Absolute neutrophil count >1000/mm3
ALT/AST <2.5 times the upper limit of normal (ULN)
Total bilirubin <1.5 times ULN
Creatinine <1.5 mg/dL
Female subjects of childbearing potential must have a negative serum pregnancy test at screening; subjects must agree to use a medically appropriate form of birth control from screening until 6 months after the last dose of study medication
Ability to provide written informed consent

Exclusion Criteria:

Any significant diseases (other than HL) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the subject from participating in the study
History or clinical evidence of cnetral nervous system (CNS) HL
Received allogeneic BMT
Received growth factor support or transfusions to achieve hematology entry criteria (platelets, hemoglobin, absolute neutrophil count)
Major surgery within 4 weeks prior to study entry
Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation
Known history of another primary malignancy that has not been in remission for at least 5 years. Non-melanoma skin cancer and cervical carcinoma in situ or squamous intraepithelial lesions (e.g., cervical intraepithelial neoplasia [CIN] or prostatic intraepithelial/intraductal neoplasia [PIN]) are allowed.
Any active viral, bacterial, or systemic fungal infection within 4 weeks prior study entry
Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV)
Histry of significant chronic or recurrent infections requiring treatment
Receiving systemic steroids exceeding 10 mg prednisone or equivalent, or unstable on steroid medication, during the 3 weeks immediately preceding enrollment
Pregnant or breast-feeding