Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry

Completed

• Conditions: Peripheral T-cell Lymphoma

• Registration Number: NCT01110733
• Lead Sponsor: Acrotech Biopharma Inc.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (68)

DCH Cancer Treatment Center; 🇺🇸 Tuscaloosa, Alabama, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Genesis Cancer Center; 🇺🇸 Hot Springs, Arkansas, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

Moores Cancer Center UCSD; 🇺🇸 La Jolla, California, United States

Wilshire Oncology Medical Group; 🇺🇸 La Verne, California, United States

UCLA; 🇺🇸 Los Angeles, California, United States

USC & Norris Cancer Center; 🇺🇸 Los Angeles, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

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