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

January 8, 2020 updated by: Acrotech Biopharma Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35401
        • DCH Cancer Treatment Center
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • La Jolla, California, United States, 92037
        • Moores Cancer Center UCSD
      • La Verne, California, United States, 91750
        • Wilshire Oncology Medical Group
      • Los Angeles, California, United States, 90025
        • UCLA
      • Los Angeles, California, United States, 90033
        • USC & Norris Cancer Center
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
      • Sylmar, California, United States, 91342
        • UCLA Olive View Medical Center
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital Praxair Cancer Center
      • New Haven, Connecticut, United States, 06510
        • Yale University School Of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute at Washington Hospital Center
    • Florida
      • Coral Springs, Florida, United States, 33065
        • Coral Springs Oncology
      • Lake Worth, Florida, United States, 33463
        • Medical Specialists of the Palm Beaches
      • Loxahatchee Groves, Florida, United States, 33463
        • Hematology Oncology Associates
      • Miami, Florida, United States, 33146
        • University of Miami
      • Orlando, Florida, United States, 32806
        • MD Anderson Orlando
      • Tampa, Florida, United States, 32806
        • Moffit Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Georgia Cancer Specialists
      • Atlanta, Georgia, United States, 30322
        • Emory University Cancer Center
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Idaho
      • Post Falls, Idaho, United States, 83854
        • Kootenai Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University Of Chicago Medical Center
      • Chicago, Illinois, United States, 60208
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • John H. Stroger, Jr. Hospital of Cook County
      • Chicago, Illinois, United States, 60612
        • UIC Cancer Center
      • Springfield, Illinois, United States, 62702
        • Simmons Cooper Cancer Institute at SIU School of Medicine
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Simon Cancer Center
      • Indianapolis, Indiana, United States, 46237
        • St. Francis Medical Group Oncology and Hematology Associates
    • Louisiana
      • Shreveport, Louisiana, United States, 70112
        • Louisiana State University Health Science Center (LSUHSC)
    • Maryland
      • Baltimore, Maryland, United States, 20742
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Lambertville, Michigan, United States, 48144
        • ProMedica
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Metro Minnesota Community Clinical Oncology Program
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University Cancer Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Cancer Institute Of New Jersey
      • Summit, New Jersey, United States, 07960
        • Overlook Hospital and Morristown Memorial Hospital
    • New York
      • Buffalo, New York, United States, 14203
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10065
        • New York University Clinical Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Chapel Hill
      • Concord, North Carolina, United States, 28025
        • Carolinas Medical Center Northeast
      • Fayetteville, North Carolina, United States, 28304
        • Carolina Cancer Management, Inc.
    • Ohio
      • Lorain, Ohio, United States, 44035
        • Community Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinic, Ltd
    • Tennessee
      • Memphis, Tennessee, United States, 37920
        • University of Tennessee Cancer Institute
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • Ut Southwestern
      • Fort Worth, Texas, United States, 76104
        • Center for Cancer and Blood Disorders
      • Fort Worth, Texas, United States, 76104
        • JPS Center for Cancer Care
      • San Antonio, Texas, United States, 76104
        • South Texas Oncology and Hematology, P.A.
      • Tyler, Texas, United States, 75766
        • Tyler Hematology Oncology, PA
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acrotech Biopharma Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Francine Foss, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COMPLETE Registry

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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