Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Summary
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.
Arms & interventions
- GeneticGene-modified (GM) T cell therapy
No investigational product will be administered
Outcome measures
Primary
Incidence of delayed Adverse Events (AEs)
Time frame: Up to 15 years from last gene-modified (GM) T cell infusion
Persistence of GM T cell drug products
Time frame: Up to 15 years from last GM T cell infusion
Analysis of vector integration sites
Time frame: Up to 15 years from last GM T cell infusion
Incidence of replication-competent lentiviruses
Time frame: Up to 15 years from last GM T cell infusion
Physical growth as assessed by physical examination (pediatric participants only)
Time frame: Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached
Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only)
Time frame: Up to 15 years from last GM T cells infusion or until Tanner Stage 5
Proportion of participants who progressed on the study: participants with original diagnosis of malignancies
Time frame: Up to 15 years from last GM T cells infusion
Overall Survival (participants with original diagnosis of malignancies)
Time frame: Up to 15 years from last GM T cells infusion
Secondary
Lymphocyte count (B-cell)
Time frame: Up to 15 years
Eligibility criteria
Study locations (100)
University of Alabama Birmingham
Birmingham, Alabama, 10016
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
Local Institution - 01039
Scottsdale, Arizona, 85258
Local Institution - 01021
Tucson, Arizona, 85724
City Of Hope
Duarte, California, 91010
University Of California San Diego Moores Cancer Center
La Jolla, California, 92093
Local Institution - 01206
Los Angeles, California, 90048
Local Institution - 01043
Sacramento, California, 95816
University of California, San Francisco- California
San Francisco, California, 94143
UCLA Medical Centre-Santa Monica
Santa Monica, California, 90095
Stanford Cancer Center
Stanford, California, 94305
University Of Colorado Cancer Center
Aurora, Colorado, 80045
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Yale Cancer Center
New Haven, Connecticut, 06520
Local Institution - 01050
Washington D.C., District of Columbia, 20007
The Mayo Clinic - Jacksonville, Davis-E
Jacksonville, Florida, 32224
Baptist Cancer Center
Miami, Florida, 33176
Local Institution - 01035
Orlando, Florida, 32804
H. Lee Moffitt Cancer Center and Research Institute University of South Florida
Tampa, Florida, 33612
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Northside Hospital, Inc
Atlanta, Georgia, 30342
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University Of Chicago Medical Center
Chicago, Illinois, 60637-1447
Local Institution - 01040
Maywood, Illinois, 60153
Local Institution - 01063
Niles, Illinois, 60714
IN Univ Simon Cancer Center
Indianapolis, Indiana, 46202
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
Local Institution - 01020
Indianapolis, Indiana, 46237
Kansas University Medical Center
Westwood, Kansas, 66205
Cancer Center of Kansas
Wichita, Kansas, 67214
University Of Kentucky
Lexington, Kentucky, 40536
Norton Cancer Institute Louisville Oncology
Louisville, Kentucky, 40207
Local Institution - 01026
New Orleans, Louisiana, 70112
University of Maryland - Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Sidney Kimmel Comp Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
National Cancer Institute
Bethesda, Maryland, 20892-1203
Local Institution - 01107
Boston, Massachusetts, 02114
Massachusetts General Hospital / Dana-Farber Cancer Institute
Boston, Massachusetts, 02114
Local Institution - 01106
Boston, Massachusetts, 02115
University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Karmanos Cancer Center Wayne State University
Detroit, Michigan, 48201
Providence Cancer Institute
Southfield, Michigan, 48075
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, 55455
Mayo Clinic
Rochester, Minnesota, 55905
Siteman Cancer Center
St Louis, Missouri, 63110
University Of Nebraska Medical Center
Omaha, Nebraska, 68198-6840
Local Institution - 01030
East Brunswick, New Jersey, 08816
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Morristown Memorial Hosp
Morristown, New Jersey, 07962
Local Institution - 01053
New Brunswick, New Jersey, 08903
New York Oncology Hematology P.C.
Albany, New York, 12206
Roswell Park Cancer Institute
Buffalo, New York, 14263
Local Institution - 01066
New York, New York, 10016
New York University - Langone Medical Center - The Center for Musculoskeletal Care
New York, New York, 10016
Weill Cornell Medicine / New York Presbyterian Hospital
New York, New York, 10021
Icahn School Of Medicine At Mount Sinai
New York, New York, 10029
Columbia University Medical Center/New York-Presbyterian Hospital
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Local Institution - 01051
Rochester, New York, 14642
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Levine Cancer Institute
Charlotte, North Carolina, 28204
Duke University Medical Center
Durham, North Carolina, 27705
Novant Health
Salisbury, North Carolina, 28147
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
University Hospitals of Cleveland
Cleveland, Ohio, 44106-5000
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Willamette Valley Cancer Institute
Eugene, Oregon, 97401
Providence Portland Medical Center
Portland, Oregon, 97213
Oregon Health and Science University OHSU
Portland, Oregon, 97239
Children's Hospital of Philadelphia-Center for Childhood Cancer Research
Philadelphia, Pennsylvania, 19104
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, 15232
Hematology and Oncology Associates of SC, LLC
Greenville, South Carolina, 29615
Local Institution - 01064
Sioux Falls, South Dakota, 57105
Sarah Cannon Research Inst
Nashville, Tennessee, 37203
Texas Oncology
Dallas, Texas, 75230
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
UT Southwestern Medical Center
Dallas, Texas, 75390
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Texas- MD Anderson
Houston, Texas, 77030
Sam Clinical Research Center
San Antonio, Texas, 78229
Local Institution - 01033
Temple, Texas, 76508
Local Institution - 01054
Tyler, Texas, 75702
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Intermountain Healthcare - LDS Hospital
Salt Lake City, Utah, 84143
University Of Virginia Health System
Charlottesville, Virginia, 22903
Local Institution - 01045
Norfolk, Virginia, 23502
Local Institution - 01023
Richmond, Virginia, 23298
Swedish Cancer Institute
Seattle, Washington, 98104
Local Institution - 01060
Seattle, Washington, 98105
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Local Institution - 01055
Tacoma, Washington, 98405
University Of Wisconsin
Madison, Wisconsin, 53705
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Local Institution - 01069
Wauwatosa, Wisconsin, 53226
References
- Abramson JS, Siddiqi T, Gordon LI, Lunning MA, Wang M, Arnason JE, Kamdar M, Maloney DG, Shadman M, Andreadis CB, Sehgal A, Solomon SR, Ghosh N, Hidalgo-Lopez JE, Wang J, Ding X, Ogasawara K, Singh A, Palomba ML. Five-year survival outcomes from TRANSCEND NHL 001 of lisocabtagene maraleucel in R/R LBCL. Blood. 2026 Jun 3:blood.2025032270. doi: 10.1182/blood.2025032270. Online ahead of print.(PubMed)
- Abramson JS, Palomba ML, Gordon LI, Lunning M, Wang M, Arnason J, Purev E, Maloney DG, Andreadis C, Sehgal A, Solomon SR, Ghosh N, Dehner C, Kim Y, Ogasawara K, Kostic A, Siddiqi T. Two-year follow-up of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphoma in TRANSCEND NHL 001. Blood. 2024 Feb 1;143(5):404-416. doi: 10.1182/blood.2023020854.(PubMed)