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Purpose

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 GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Received at least one gene-modified (GM) T-cell 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. - Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.

Exclusion Criteria

Not Applicable Other protocol-defined inclusion/exclusion criteria apply

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Participants exposed to Gene-modified (GM) T cell therapy
  • Genetic: Gene-modified (GM) T cell therapy
    No investigational product will be administered

Recruiting Locations

University of Alabama Birmingham
Birmingham, Alabama 10016
Contact:
Luciano Costa, Site 01171
205-934-9695

Sarah Cannon Research Inst
Nashville, Tennessee 37203
Contact:
Jesus Berdeja, Site 01101
615-329-0570

Oncology Hematology Care, Inc.
Cincinnati, Ohio 45242
Contact:
James Essell, Site 01037
513-686-5482

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Brian Hill, Site 01062
216-445-9451

Providence Portland Medical Center
Portland, Oregon 97213
Contact:
Stacy Lewis, Site 01028
503-215-5696

University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
Contact:
Stephen Schuster, Site 01016
215-614-1846

Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania 19107
Contact:
Usama Gergis, Site 01173
917-698-4310

UPMC Cancer Pavillion
Pittsburgh, Pennsylvania 15232
Contact:
Alison Sehgal, Site 01210
412-648-6579

Hematology and Oncology Associates of SC, LLC
Greenville, South Carolina 29615
Contact:
Saeeda Chowdhury, Site 01034
000-000-0000

Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
Contact:
Houston Holmes, Site 01180
214-584-3402

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Maria Palomba, Site 01177
212-639-2000

University of Texas- MD Anderson
Houston, Texas 77030
Contact:
Hun Ju Lee, Site 01013
713-792-2860

Sam Clinical Research Center
San Antonio, Texas 78229
Contact:
Julio Cesar Alvarenga Thiebaud, Site 01211

Texas Oncology, P.A. - Tyler
Tyler, Texas 75702
Contact:
Habte Yimer, Site 01054
903-579-9800

University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah 84112
Contact:
Douglas Sborov, Site 01199
801-585-0255

University Of Virginia Health System
Charlottesville, Virginia 22903
Contact:
Indumathy Varadarajan, Site 01065
434-924-9333

Fred Hutchinson Cancer Center
Seattle, Washington 98109
Contact:
Jordan Gauthier, Site 01110
206-667-2713

University Of Wisconsin
Madison, Wisconsin 53705
Contact:
Natalie Callander, Site 01036
608-265-8554

Levine Cancer Institute
Charlotte, North Carolina 28204
Contact:
Bei Hu, Site 01204
704-770-7863

Columbia University Medical Center/New York-Presbyterian Hospital
New York, New York 10032
Contact:
Ran Reshef, Site 01209
212-342-0530

Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
Contact:
Rajneesh Nath, Site 01049
480-256-3223

Northwestern Memorial Hospital
Chicago, Illinois 60611
Contact:
Reem Karmali, Site 01014
312-695-0990

Mayo Clinic Phoenix
Phoenix, Arizona 85054
Contact:
Peter Bergsagel, Site 01200
480-342-4800

University of California, San Francisco- California
San Francisco, California 94143
Contact:
Charalambos Andreadis, Site 01108
415-353-2421

University Of Colorado Cancer Center
Aurora, Colorado 80045
Contact:
Manali Kamdar, Site 01208
720-848-0752

Yale Cancer Center
New Haven, Connecticut 06520
Contact:
Iris Isufi, Site 01059
203-688-4242

The Mayo Clinic - Jacksonville, Davis-E
Jacksonville, Florida 32224
Contact:
Sikander Ailawadhi, Site 01201
904-953-2000

Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
Contact:
Sagar Lonial, Site 01103
404-778-1900

Northside Hospital, Inc
Atlanta, Georgia 30342
Contact:
Scott Solomon, Site 01207
404-255-1930

University Of Chicago Medical Center
Chicago, Illinois 60637-1447
Contact:
Peter Riedell, Site 01018
773-702-8412

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Francisco Hernandez-Ilizaliturri, Site 01111
716-845-3099

IN Univ Simon Cancer Center
Indianapolis, Indiana 46202
Contact:
Rafat Abonour, Site 01161
317-690-1577

Norton Cancer Institute Louisville Oncology
Louisville, Kentucky 40207
Contact:
Don Stevens, Site 01032
502-899-3366

Sidney Kimmel Comp Cancer Center at Johns Hopkins
Baltimore, Maryland 21231
Contact:
Syed Abbas Ali, Site 01017
443-287-7104

Massachusetts General Hospital / Dana-Farber Cancer Institute
Boston, Massachusetts 02114
Contact:
Jeremy Abramson, Site 01012
617-571-3037

University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Contact:
Monalisa Ghosh, Site 01024
734-765-4280

Karmanos Cancer Center Wayne State University
Detroit, Michigan 48201
Contact:
Abhinav Deol, Site 01025
313-576-8093

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Yi Lin, Site 01105
507-398-8683

University Of Nebraska Medical Center
Omaha, Nebraska 68198-6840
Contact:
Matthew Lunning, Site 01015
402-559-7164

Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Meera Mohan, Site 01178
414-805-4600

More Details

NCT ID
NCT03435796
Status
Recruiting
Sponsor
Celgene

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.