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A Phase I/II, Non-Randomized,Multiple-Dose,Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TNX-650 in Patients With Refractory Hodgkin's Lymphoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Hodgkin's Lymphoma

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Trial Information

A Phase I/II, Non-Randomized,Multiple-Dose,Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TNX-650 in Patients With Refractory Hodgkin's Lymphoma

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.

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety and tolerability of TNX-650 for Injection when administered to patients with refractory Hodgkin's Lymphoma (HL)

Principal Investigator

Anas Younes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

June 2007

Related Keywords:

  • Hodgkin's Lymphoma
  • Hodgkin Disease
  • Lymphoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
MD Anderson Cancer Center - Dept. of Lymphoma and Myeloma Houston, Texas  77030-4009