RECRUITING

Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

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Conditions

NeoplasmsLong-term follow upGene-Modified T CellsCAR T Cell

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

Official Title

Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

Quick Facts

Study Start:2018-07-19
Study Completion:2036-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03435796

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
  2. * Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

University of Alabama Birmingham
Birmingham, Alabama, 10016
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
United States
Arizona Cancer Center
Scottsdale, Arizona, 85258
United States
Local Institution - 01021
Tucson, Arizona, 85724
United States
City Of Hope
Duarte, California, 91010
United States
University Of California San Diego Moores Cancer Center
La Jolla, California, 92093
United States
Local Institution - 01206
Los Angeles, California, 90048
United States
Local Institution - 01043
Sacramento, California, 95816
United States
University of California, San Francisco- California
San Francisco, California, 94143
United States
UCLA Medical Centre-Santa Monica
Santa Monica, California, 90095
United States
Local Institution - 01119
Stanford, California, 94305
United States
University Of Colorado Cancer Center
Aurora, Colorado, 80045
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Yale Cancer Center
New Haven, Connecticut, 06520
United States
Local Institution - 01050
Washington, District of Columbia, 20007
United States
The Mayo Clinic - Jacksonville, Davis-E
Jacksonville, Florida, 32224
United States
Baptist Cancer Center
Miami, Florida, 33176
United States
Local Institution - 01035
Orlando, Florida, 32804
United States
H. Lee Moffitt Cancer Center and Research Institute University of South Florida
Tampa, Florida, 33612
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
United States
Northside Hospital, Inc
Atlanta, Georgia, 30342
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
University Of Chicago Medical Center
Chicago, Illinois, 60637-1447
United States
Local Institution - 01040
Maywood, Illinois, 60153
United States
Local Institution - 01063
Niles, Illinois, 60714
United States
IN Univ Simon Cancer Center
Indianapolis, Indiana, 46202
United States
Local Institution - 01020
Indianapolis, Indiana, 46237
United States
Kansas University Medical Center
Westwood, Kansas, 66205
United States
Cancer Center of Kansas
Wichita, Kansas, 67214
United States
University Of Kentucky
Lexington, Kentucky, 40536
United States
Norton Cancer Institute Louisville Oncology
Louisville, Kentucky, 40207
United States
Local Institution - 01026
New Orleans, Louisiana, 70112
United States
University of Maryland - Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
United States
Sidney Kimmel Comp Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States
National Cancer Institute
Bethesda, Maryland, 20892-1203
United States
Local Institution - 01107
Boston, Massachusetts, 02114
United States
Massachusetts General Hospital / Dana-Farber Cancer Institute
Boston, Massachusetts, 02114
United States
Local Institution - 01106
Boston, Massachusetts, 02115
United States
University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
United States
Karmanos Cancer Center Wayne State University
Detroit, Michigan, 48201
United States
Providence Cancer Institute
Southfield, Michigan, 48075
United States
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, 55455
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Siteman Cancer Center
Saint Louis, Missouri, 63110
United States
University Of Nebraska Medical Center
Omaha, Nebraska, 68198-6840
United States
Local Institution - 01030
East Brunswick, New Jersey, 08816
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Morristown Memorial Hosp
Morristown, New Jersey, 07962
United States
Local Institution - 01053
New Brunswick, New Jersey, 08903
United States
New York Oncology Hematology P.C.
Albany, New York, 12206
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Local Institution - 01066
New York, New York, 10016
United States
Weill Cornell Medicine / New York Presbyterian Hospital
New York, New York, 10021
United States
Icahn School Of Medicine At Mount Sinai
New York, New York, 10029
United States
Columbia University Medical Center/New York-Presbyterian Hospital
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Local Institution - 01051
Rochester, New York, 14642
United States
Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
Duke University Medical Center
Durham, North Carolina, 27705
United States
Local Institution - 01058
Salisbury, North Carolina, 28147
United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
United States
Local Institution - 01042
Cleveland, Ohio, 44106-5000
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Local Institution - 01074
Columbus, Ohio, 43210
United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Willamette Valley Cancer Institute
Eugene, Oregon, 97401
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Oregon Health and Science University OHSU
Portland, Oregon, 97239
United States
Children's Hospital of Philadelphia-Center for Childhood Cancer Research
Philadelphia, Pennsylvania, 19104
United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
United States
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, 19107
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, 15232
United States
Hematology and Oncology Associates of SC, LLC
Greenville, South Carolina, 29615
United States
Local Institution - 01064
Sioux Falls, South Dakota, 57105
United States
Sarah Cannon Research Inst
Nashville, Tennessee, 37203
United States
Texas Oncology
Dallas, Texas, 75230
United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
University of Texas- MD Anderson
Houston, Texas, 77030
United States
Sam Clinical Research Center
San Antonio, Texas, 78229
United States
Local Institution - 01033
Temple, Texas, 76508
United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, 75702
United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Intermountain Healthcare - LDS Hospital
Salt Lake City, Utah, 84143
United States
University Of Virginia Health System
Charlottesville, Virginia, 22903
United States
Local Institution - 01045
Norfolk, Virginia, 23502
United States
Local Institution - 01023
Richmond, Virginia, 23298
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
Local Institution - 01060
Seattle, Washington, 98105
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
Local Institution - 01055
Tacoma, Washington, 98405
United States
University Of Wisconsin
Madison, Wisconsin, 53705
United States
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Local Institution - 01069
Wauwatosa, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Celgene

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

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 Registration Dates

Study Start Date2018-07-19
Study Completion Date2036-11-30

Study Record Updates

Study Start Date2018-07-19
Study Completion Date2036-11-30

Terms related to this study

Keywords Provided by Researchers

  • Long-term follow up
  • Gene-Modified T Cells
  • CAR T Cell

Additional Relevant MeSH Terms

  • Neoplasms