Peripheral T-cell LymphomaCOMPLETENCT01110733
Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry
An observational study of Peripheral T-cell Lymphoma, run by Acrotech Biopharma Inc. at 68 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral T-cell Lymphoma
- How many people
- 3,000 participants
- Where
- 68 sitesUnited States
- Study dates
- Feb 2010to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be enrolled from academic and community cancer centers in the United States, France, Germany, Italy and Japan.
Who may be able to join
- 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)
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
68 sites in 1 country.
68 sites in 1 country
United States68 sites
Emory University Cancer Center
Atlanta, Georgia, 30322
Georgia Cancer Specialists
Atlanta, Georgia, 30341
Medical College of Georgia
Augusta, Georgia, 30912
University of Maryland
Baltimore, Maryland, 20742
Boston Medical Center
Boston, Massachusetts, 02118
Roswell Park Cancer Institute
Buffalo, New York, 14203
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
University of Virginia Health System
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60208
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612
Rush University Medical Center
Chicago, Illinois, 60612
UIC Cancer Center
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
Carolinas Medical Center Northeast
Concord, North Carolina, 28025
Coral Springs Oncology
Coral Springs, Florida, 33065
UT Southwestern
Dallas, Texas, 75390
Danbury Hospital Praxair Cancer Center
Danbury, Connecticut, 06810
City of Hope National Medical Center
Duarte, California, 91010
Michigan State University
East Lansing, Michigan, 48824
Carolina Cancer Management, Inc.
Fayetteville, North Carolina, 28304
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
JPS Center for Cancer Care
Fort Worth, Texas, 76104
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Genesis Cancer Center
Hot Springs, Arkansas, 71913
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
St. Francis Medical Group Oncology and Hematology Associates
Indianapolis, Indiana, 46237
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Research Medical Center
Kansas City, Missouri, 64132
Moores Cancer Center UCSD
La Jolla, California, 92037
Wilshire Oncology Medical Group
La Verne, California, 91750
Medical Specialists of the Palm Beaches
Lake Worth, Florida, 33463
ProMedica
Lambertville, Michigan, 48144
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Community Cancer Center
Lorain, Ohio, 44035
UCLA
Los Angeles, California, 90025
USC & Norris Cancer Center
Los Angeles, California, 90033
Hematology Oncology Associates
Loxahatchee Groves, Florida, 33463
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53705
University of Tennessee Cancer Institute
Memphis, Tennessee, 37920
University of Miami
Miami, Florida, 33146
West Virginia University
Morgantown, West Virginia, 26506
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Yale University School of Medicine
New Haven, Connecticut, 06510
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
New York University Clinical Cancer Center
New York, New York, 10065
MD Anderson Orlando
Orlando, Florida, 32806
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Kootenai Cancer Center
Post Falls, Idaho, 83854
University of Rochester
Rochester, New York, 14642
Metro Minnesota Community Clinical Oncology Program
Saint Louis Park, Minnesota, 55426
South Texas Oncology and Hematology, P.A.
San Antonio, Texas, 76104
Guthrie Clinic, Ltd
Sayre, Pennsylvania, 18840
Louisiana State University Health Science Center (LSUHSC)
Shreveport, Louisiana, 70112
Simmons Cooper Cancer Institute at SIU School of Medicine
Springfield, Illinois, 62702
St. Louis University Cancer Center
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
Overlook Hospital and Morristown Memorial Hospital
Summit, New Jersey, 07960
UCLA Olive View Medical Center
Sylmar, California, 91342
Moffit Cancer Center
Tampa, Florida, 32806
Arizona Cancer Center
Tucson, Arizona, 85724
DCH Cancer Treatment Center
Tuscaloosa, Alabama, 35401
Tyler Hematology Oncology, PA
Tyler, Texas, 75766
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20010
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- Non-Hodgkins Lymphoma, Non-Hodgkin's Lymphoma, Lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoma, Non-Hodgkin, Lymphoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acrotech Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francine Foss, MD, Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110733
- Sponsor's protocol ID
- COMPLETE Registry
- Acronym
- COMPLETE
- Status last verified
- Jan 2020
- First submitted
- 23 Apr 2010
- Last updated
- 13 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Longitudinal, Multinational Registry of Patients With Newly Diagnosed Peripheral T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01110733
- Acronym / sponsor ID
- COMPLETE / COMPLETE Registry
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- Non-Hodgkins Lymphoma, Non-Hodgkin's Lymphoma, Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Acrotech Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be enrolled from academic and community cancer centers in the United States, France, Germany, Italy and Japan.
Key inclusion criteria (18 listed)
- Patient is newly diagnosed with Peripheral T-cell Lymphoma (PTCL):
- Patient gives written informed consent
Key exclusion criteria (6 listed)
- Patient has other T- or NK-cell malignancies including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francine Foss, MD study chair
Yale University
68 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral T-cell Lymphoma, run by Acrotech Biopharma Inc. at 68 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.