Safety and Efficacy Study of TNX-650 to Treat Refractory Hodgkin's Lymphoma
The purpose of this study is to determine the safety and effectiveness of TNX-650 for Injection when administered to patients with 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00441818.
Hodgkin's lymphoma (HL) is a lymphoid malignancy that accounts for approximately 7,000 to
8,000 new cancer cases per year in the United Sates. It occurs with a bimodal
age-incidence distribution peaking in the 15- to 30-year old and 50- to 60-year old age
groups. The pathological hallmark of the disease is the presence of malignant Reed
Sternberg (RS) cells. Reed-Sternberg cells are interspersed among a heterogeneous
population of non-malignant reactive cells, including T cells, eosinophils, neutrophils,
B lymphocytes, plasma cells, histiocytes, fibroblasts, and stromal cells.
While more than 80% of patients will respond to initial radiotherapy or combination
chemoradiotherapy, some patients will experience early relapse after initial therapy or
be refractory to first-line therapy. These patients may be treated with second-line
therapy, which may include autologous bone marrow transplantation (BMT). Patients with HL
who relapse after first- and second-line therapy, or who are refractory to therapy, with
or without autologous BMT, have a poor prognosis. The long-term event-free survival rate
in this patient group is less than 10%; median survival is 16 months. At present, these
patients have no treatment options other than investigational therapies.
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationTanox
- Primary IDTNX-650.101
- Secondary IDsNCI-2010-00951
- ClinicalTrials.gov IDNCT00441818