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Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry (COMPLETE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01110733
First received: April 23, 2010
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition
Peripheral T-cell Lymphoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective, Longitudinal, Multinational Registry of Patients With Newly Diagnosed Peripheral T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Estimated Enrollment: 3000
Study Start Date: February 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110733

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

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01110733     History of Changes
Other Study ID Numbers: COMPLETE Registry
Study First Received: April 23, 2010
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration
France: Institutional Ethical Committee
Germany: Ethics Commission
Italy: Ethics Committee
Japan: Institutional Review Board

Keywords provided by Spectrum Pharmaceuticals, Inc:
Non-Hodgkins Lymphoma
Non-Hodgkin's Lymphoma
Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on July 22, 2014