Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry

Peripheral T-cell Lymphoma Clinical Trial

— COMPLETE  

Official title:

Prospective, Longitudinal, Multinational Registry of Patients With Newly Diagnosed Peripheral T-Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110733
• Other study ID #: COMPLETE Registry
• Status: Completed
• Start date: February 2010
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: Acrotech Biopharma LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 (?/d) 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Acrotech Biopharma LLC

Country where clinical trial is conducted

United States,