Brief Summary

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Official Title: "Prospective, Longitudinal, Multinational Registry of Patients With Newly Diagnosed Peripheral T-Cell Lymphoma"

The COMPLETE registry is a prospective, longitudinal, multinational, observational study that will collect data on how patients with peripheral T-cell lymphoma (PTCL) are treated in academic and community practices. The registry will enroll newly-diagnosed patients with PTCL treated with a variety of regimens. The COMPLETE registry is designed to better understand PTCL patient characteristics, treatments, and outcomes to help design and understand future clinical trials.

• Study Type: Observational
• Study Design: Observational Model: Case-Only, Time Perspective: Prospective
• Study Primary Completion Date: February 2015

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• Patient is newly diagnosed with Peripheral T-cell Lymphoma (PTCL):
• Aggressive natural killer (NK)-cell leukemia
• Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+)
• Angioimmunoblastic T-cell lymphoma
• Anaplastic large cell lymphoma (ALCL), primary systemic type (ALK+, ALK-)
• PTCL, not otherwise specified (NOS)
• T/NK-cell lymphoma, nasal type
• Enteropathy-type intestinal lymphoma
• Hepatosplenic T-cell lymphoma
• Subcutaneous panniculitis T-cell lymphoma
• Transformed mycosis fungoides (at diagnosis of transformation)
• T-cell prolymphocytic leukemia (T-PLL)
• Cutaneous gamma/delta (γ/δ) T-cell lymphoma
• Cutaneous aggressive CD8+ T-cell lymphoma
• Hematodermic neoplasms (blastic plasmacytoid dendritic cell neoplasm)
• Systemic Epstein Barr Virus (EBV)+ T-cell lymphomas (T-cell lymphoproliferative disorders of childhood)
• Other T-Cell lymphomas that are not listed in the Exclusion Criteria
• Patient gives written informed consent

Exclusion Criteria

• Patient has other T- or NK-cell malignancies including:
• Precursor T/NK neoplasms
• T-cell large granular lymphocytic leukemia
• Mycosis fungoides, other than transformed mycosis fungoides
• Sézary syndrome
• Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Spectrum Pharmaceuticals, Inc
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Francine Foss, MD, Study Chair, Yale University
• Overall Contact(s)
  • Heidi Vosseler, 215-801-4017, complete.ptcl@actsolutions.org