Clinical trial NCT01110733: Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry
Official title: Prospective, Longitudinal, Multinational Registry of Patients With Newly Diagnosed Peripheral T-Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral T-cell Lymphoma
Keywords: Non-Hodgkins Lymphoma
Non-Hodgkin's Lymphoma
Lymphoma
Lead sponsor: Acrotech Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be enrolled from academic and community cancer centers in the United States, France, Germany, Italy and Japan.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: DCH Cancer Treatment Center
state: Alabama
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center UCSD
state: California
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Los Angeles
country: United States
facility: USC & Norris Cancer Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Sylmar
country: United States
facility: UCLA Olive View Medical Center
state: California
city: Danbury
country: United States
facility: Danbury Hospital Praxair Cancer Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Washington Cancer Institute at Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Coral Springs
country: United States
facility: Coral Springs Oncology
state: Florida
city: Lake Worth
country: United States
facility: Medical Specialists of the Palm Beaches
state: Florida
city: Loxahatchee Groves
country: United States
facility: Hematology Oncology Associates
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: MD Anderson Orlando
state: Florida
city: Tampa
country: United States
facility: Moffit Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Cancer Center
state: Georgia
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Post Falls
country: United States
facility: Kootenai Cancer Center
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: UIC Cancer Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Springfield
country: United States
facility: Simmons Cooper Cancer Institute at SIU School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: St. Francis Medical Group Oncology and Hematology Associates
state: Indiana
city: Shreveport
country: United States
facility: Louisiana State University Health Science Center (LSUHSC)
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Lambertville
country: United States
facility: ProMedica
state: Michigan
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Clinical Oncology Program
state: Minnesota
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Summit
country: United States
facility: Overlook Hospital and Morristown Memorial Hospital
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: New York University Clinical Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Concord
country: United States
facility: Carolinas Medical Center Northeast
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Cancer Management, Inc.
state: North Carolina
city: Lorain
country: United States
facility: Community Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Clinic, Ltd
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee Cancer Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Fort Worth
country: United States
facility: Center for Cancer and Blood Disorders
state: Texas
city: Fort Worth
country: United States
facility: JPS Center for Cancer Care
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology, P.A.
state: Texas
city: Tyler
country: United States
facility: Tyler Hematology Oncology, PA
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: Yale University
name: Francine Foss, MD
role: STUDY_CHAIR
References: