Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Status: | Recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 3/31/2019 |
Start Date: | June 19, 2018 |
End Date: | November 30, 2032 |
Contact: | Associate Director Clinical Trial Disclosure |
Email: | clinicaltrialdisclosure@celgene.com |
Phone: | 1-888-260-1599 |
LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH CAR T CELLS
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all
pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a
previous Celgene sponsored or Celgene alliance partner sponsored study.
Subjects who received at least one GM T cell infusion, will be asked to roll-over to this
LTFU protocol upon either premature discontinuation from, or completion of the prior parent
treatment protocol.
pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a
previous Celgene sponsored or Celgene alliance partner sponsored study.
Subjects who received at least one GM T cell infusion, will be asked to roll-over to this
LTFU protocol upon either premature discontinuation from, or completion of the prior parent
treatment protocol.
Subjects participating in this study will be followed from time of roll-over from the parent
GM T protocol until 15 years after the last GMT infusion, withdrawal of consent, lost to
follow-up, or death, whichever occurs first. Both local and central laboratory evaluations
and safety assessments will be conducted during this trial. In addition, pediatric subjects
will be monitored for growth, development and sexual maturity.
Stage 5 per Tanner Staging Criteria must be reached prior to study discontinuation.
GM T protocol until 15 years after the last GMT infusion, withdrawal of consent, lost to
follow-up, or death, whichever occurs first. Both local and central laboratory evaluations
and safety assessments will be conducted during this trial. In addition, pediatric subjects
will be monitored for growth, development and sexual maturity.
Stage 5 per Tanner Staging Criteria must be reached prior to study discontinuation.
Inclusion Criteria:
Subjects who meet the following criteria will be eligible to participate in the Long-Term
Follow-Up study:
1. All adult and pediatric subjects who received at least one GM T cells infusion in a
previous Celgene sponsored or Celgene alliance partner sponsored study, and have
discontinued, or completed the post-treatment follow-up period in the parent treatment
protocol, as applicable.
2. Subject (and, parental/legal representative, when applicable) must understand and
voluntarily sign an Informed Consent Form/Informed Assent Form prior to any
study-related assessments/procedures being conducted.
3. Subject is willing and able to adhere to the study visit schedule and other protocol
requirements.
Exclusion Criteria:
We found this trial at
61
sites
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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4117 East Fowler Avenue
Tampa, Florida 33612
Tampa, Florida 33612
(813) 745-4673
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Moffitt Cancer...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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525 East 68th Street
New York, New York 10065
New York, New York 10065
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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