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

NCT03435796 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: GC-LTFU-001U1111-1206-82502023-504201-36
• Study Type: interventional
• Target: 1,541
• Locations: 19 countries
• Sites: 197

Brief 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.

Conditions

Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Incidence of delayed Adverse Events (AEs)

  Up to 15 years from last gene-modified (GM) T cell infusion

• Persistence of GM T cell drug products

  Up to 15 years from last GM T cell infusion

• Analysis of vector integration sites

  Up to 15 years from last GM T cell infusion

• Incidence of replication-competent lentiviruses

  Up to 15 years from last GM T cell infusion

• Physical growth as assessed by physical examination (pediatric participants only)

  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)

  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

  Up to 15 years from last GM T cells infusion

• Overall Survival (participants with original diagnosis of malignancies)

  Up to 15 years from last GM T cells infusion

Secondary Outcomes (1)

• Lymphocyte count (B-cell)

  Up to 15 years

Study Arms (1)

Participants exposed to Gene-modified (GM) T cell therapy

OTHER

Genetic: Gene-modified (GM) T cell therapy

Interventions

Gene-modified (GM) T cell therapy GENETIC

No investigational product will be administered

Participants exposed to Gene-modified (GM) T cell therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, 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.

You may not qualify if:

• Not Applicable

Sponsors & Collaborators

• Celgene: lead

Study Sites (200)

University of Alabama Birmingham

Birmingham, Alabama, 10016, United States

RECRUITING

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

Mayo Clinic Phoenix

Phoenix, Arizona, 85054, United States

RECRUITING

Arizona Cancer Center

Scottsdale, Arizona, 85258, United States

RECRUITING

Local Institution - 01021

Tucson, Arizona, 85724, United States

WITHDRAWN

City Of Hope

Duarte, California, 91010, United States

RECRUITING

University Of California San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

Local Institution - 01206

Los Angeles, California, 90048, United States

WITHDRAWN

Local Institution - 01043

Sacramento, California, 95816, United States

WITHDRAWN

University of California, San Francisco- California

San Francisco, California, 94143, United States

RECRUITING

UCLA Medical Centre-Santa Monica

Santa Monica, California, 90095, United States

RECRUITING

Stanford Cancer Center

Stanford, California, 94305, United States

RECRUITING

University Of Colorado Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06520, United States

RECRUITING

Local Institution - 01050

Washington D.C., District of Columbia, 20007, United States

WITHDRAWN

The Mayo Clinic - Jacksonville, Davis-E

Jacksonville, Florida, 32224, United States

RECRUITING

Baptist Cancer Center

Miami, Florida, 33176, United States

RECRUITING

Local Institution - 01035

Orlando, Florida, 32804, United States

COMPLETED

H. Lee Moffitt Cancer Center and Research Institute University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Northside Hospital, Inc

Atlanta, Georgia, 30342, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

University Of Chicago Medical Center

Chicago, Illinois, 60637-1447, United States

RECRUITING

Local Institution - 01040

Maywood, Illinois, 60153, United States

WITHDRAWN

Local Institution - 01063

Niles, Illinois, 60714, United States

WITHDRAWN

IN Univ Simon Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Franciscan Health Indianapolis

Indianapolis, Indiana, 46237, United States

RECRUITING

Local Institution - 01020

Indianapolis, Indiana, 46237, United States

COMPLETED

Kansas University Medical Center

Westwood, Kansas, 66205, United States

RECRUITING

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

RECRUITING

University Of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Norton Cancer Institute Louisville Oncology

Louisville, Kentucky, 40207, United States

RECRUITING

Local Institution - 01026

New Orleans, Louisiana, 70112, United States

WITHDRAWN

University of Maryland - Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

Sidney Kimmel Comp Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

RECRUITING

National Cancer Institute

Bethesda, Maryland, 20892-1203, United States

RECRUITING

Local Institution - 01107

Boston, Massachusetts, 02114, United States

WITHDRAWN

Massachusetts General Hospital / Dana-Farber Cancer Institute

Boston, Massachusetts, 02114, United States

RECRUITING

Local Institution - 01106

Boston, Massachusetts, 02115, United States

WITHDRAWN

University Of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

Karmanos Cancer Center Wayne State University

Detroit, Michigan, 48201, United States

RECRUITING

Providence Cancer Institute

Southfield, Michigan, 48075, United States

RECRUITING

M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Siteman Cancer Center

St Louis, Missouri, 63110, United States

RECRUITING

University Of Nebraska Medical Center

Omaha, Nebraska, 68198-6840, United States

RECRUITING

Local Institution - 01030

East Brunswick, New Jersey, 08816, United States

COMPLETED

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Morristown Memorial Hosp

Morristown, New Jersey, 07962, United States

RECRUITING

Local Institution - 01053

New Brunswick, New Jersey, 08903, United States

WITHDRAWN

New York Oncology Hematology P.C.

Albany, New York, 12206, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Local Institution - 01066

New York, New York, 10016, United States

WITHDRAWN

New York University - Langone Medical Center - The Center for Musculoskeletal Care

New York, New York, 10016, United States

RECRUITING

Weill Cornell Medicine / New York Presbyterian Hospital

New York, New York, 10021, United States

RECRUITING

Icahn School Of Medicine At Mount Sinai

New York, New York, 10029, United States

RECRUITING

Columbia University Medical Center/New York-Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Local Institution - 01051

Rochester, New York, 14642, United States

WITHDRAWN

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

Novant Health

Salisbury, North Carolina, 28147, United States

RECRUITING

Oncology Hematology Care, Inc.

Cincinnati, Ohio, 45242, United States

RECRUITING

University Hospitals of Cleveland

Cleveland, Ohio, 44106-5000, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, 43210, United States

RECRUITING

University of Oklahoma Peggy and Charles Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Willamette Valley Cancer Institute

Eugene, Oregon, 97401, United States

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

Oregon Health and Science University OHSU

Portland, Oregon, 97239, United States

RECRUITING

Children's Hospital of Philadelphia-Center for Childhood Cancer Research

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Thomas Jefferson University - Clinical Research Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

UPMC Cancer Pavillion

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Hematology and Oncology Associates of SC, LLC

Greenville, South Carolina, 29615, United States

RECRUITING

Local Institution - 01064

Sioux Falls, South Dakota, 57105, United States

WITHDRAWN

Sarah Cannon Research Inst

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology

Dallas, Texas, 75230, United States

RECRUITING

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

University of Texas- MD Anderson

Houston, Texas, 77030, United States

RECRUITING

Sam Clinical Research Center

San Antonio, Texas, 78229, United States

RECRUITING

Local Institution - 01033

Temple, Texas, 76508, United States

WITHDRAWN

Texas Oncology, P.A. - Tyler

Tyler, Texas, 75702, United States

RECRUITING

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

Intermountain Healthcare - LDS Hospital

Salt Lake City, Utah, 84143, United States

RECRUITING

University Of Virginia Health System

Charlottesville, Virginia, 22903, United States

RECRUITING

Local Institution - 01045

Norfolk, Virginia, 23502, United States

COMPLETED

Local Institution - 01023

Richmond, Virginia, 23298, United States

WITHDRAWN

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

Local Institution - 01060

Seattle, Washington, 98105, United States

WITHDRAWN

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Local Institution - 01055

Tacoma, Washington, 98405, United States

WITHDRAWN

University Of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

Froedtert Hospital BMT Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Local Institution - 01069

Wauwatosa, Wisconsin, 53226, United States

NOT YET RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

RECRUITING

Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien

Vienna, 1090, Austria

RECRUITING

Jules Bordet Institut

Anderlecht, 1070, Belgium

RECRUITING

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

RECRUITING

Local Institution - 05200

Ghent, 9000, Belgium

WITHDRAWN

Uz Gent

Ghent, 9000, Belgium

RECRUITING

University Hospital Leuven

Leuven, 3000, Belgium

RECRUITING

Local Institution - UNK 2

Leuven, B-3000, Belgium

WITHDRAWN

University Of Calgary

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Local Institution - 02802

Vancouver, British Columbia, V5Z 1M9, Canada

WITHDRAWN

Local Institution - 02801

Hamilton, Ontario, L8V 1C3, Canada

WITHDRAWN

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

CIUSSS de l'Est-de-l'Ile-de-Montreal

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Helsinki University Central Hospital (HUCH)

Helsinki, 00290, Finland

RECRUITING

Hopital Henri Mondor

Creteil-Paris, 94000, France

RECRUITING

CHRU de Lille France

Lille, 59037, France

RECRUITING

Local Institution - 09601

Lyon, 69008, France

WITHDRAWN

Local Institution - 09400

Marseille, 13009, France

COMPLETED

Local Institution - 09602

Marseille, 13385, France

WITHDRAWN

CHU Montpellier - Hôpital Saint Eloi

Montpellier, 34295, France

RECRUITING

Chu Hotel Dieu

Nantes, 44093, France

RECRUITING

Hopital Saint Louis

Paris, 75010, France

RECRUITING

Hospital Saint Louis

Paris, 75475, France

RECRUITING

Local Institution - 09600

Paris, 75935, France

WITHDRAWN

Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Haut-Leveque

Pessac, 33600, France

RECRUITING

Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

RECRUITING

CHU La Miletrie

Poitiers, 86021, France

RECRUITING

Hopital Sud

Rennes, 35000, France

RECRUITING

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

RECRUITING

Gustave Roussy

Villejuif, 94805, France

RECRUITING

Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. Tumorimmuno

Berlin, 13125, Germany

RECRUITING

Local Institution - 03155

Berlin, 13353, Germany

NOT YET RECRUITING

Kinikum der Universitaeat zu Koeln

Cologne, 50937, Germany

RECRUITING

Universitatsklinikum Carl Gustav Carus an der TU Dresden

Dresden, D-01307, Germany

RECRUITING

Local Institution - 03513

Düsseldorf, 40225, Germany

WITHDRAWN

Local Institution - 03500

Frankfurt, 60590, Germany

WITHDRAWN

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20426, Germany

RECRUITING

Universitatsklinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

LMU Klinikum der Universität

München, 81377, Germany

RECRUITING

Local Institution - 03454

Münster, 48149, Germany

WITHDRAWN

Local Institution - 03503

Tübingen, 72076, Germany

COMPLETED

University Hospital of Ulm

Ulm, 89081, Germany

RECRUITING

Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II

Würzburg, 97080, Germany

RECRUITING

Soroka Medical Center

Beersheba, Southern District, 85025, Israel

RECRUITING

Hadassah Medical Center - Ein Kerem Hospital

Jerusalem, 9112001, Israel

RECRUITING

Tel-Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

The Chaim Sheba Medical Center

Tel Litwinsky, 5262100, Israel

RECRUITING

Ospedali Riuniti di Ancona

Ancona, 60126, Italy

RECRUITING

Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi

Bologna, 40138, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM)

Monza, 20900, Italy

RECRUITING

Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

Naples, 80131, Italy

RECRUITING

Local Institution - 07500

Roma, 00168, Italy

WITHDRAWN

Ospedale Pediatrico Bambino Gesu

Rome, 00165, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano (MI), 20089, Italy

RECRUITING

Local Institution - 07610

Torino, 01012, Italy

COMPLETED

Azienda Sanitaria Ospedaliera San Giovanni Battista Molinette

Turin, 10126, Italy

RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, 0608648, Japan

RECRUITING

Jichi Medical University Hospital

Shimotsuke, Tochigi, 329-0498, Japan

RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, 1040045, Japan

RECRUITING

Toranomon Hospital

Minato-ku, Tokyo, 105-8470, Japan

RECRUITING

Local Institution - 13202

Bunkyō City, 113-8677, Japan

COMPLETED

Kyushu University Hospital

Fukuoka, 812-8582, Japan

RECRUITING

Tokai University Hospital

Isehara City, Kanagawa, 259-1193, Japan

RECRUITING

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

RECRUITING

Nagoya City University Hospital

Nagoya, 467-8602, Japan

RECRUITING

Osaka Metropolitan university Hospital

Osaka, 545-8586, Japan

RECRUITING

Japan Red Cross Medical Center

Shibuya-ku, 150-8935, Japan

RECRUITING

Local Institution - 13804

Shinjuku, 162-8666, Japan

WITHDRAWN

Local Institution - 04650

Amsterdam, 1081 HV, Netherlands

COMPLETED

Erasmus Medical Center - Daniel den Hoed

Rotterdam, 3075 EA, Netherlands

RECRUITING

Local Institution - 04400

Utrecht, 3584 CS, Netherlands

WITHDRAWN

Oslo Universitetssykehus

Oslo, 0310, Norway

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

RECRUITING

St Johns Cancer Centre in Lublin

Lublin, 20-090, Poland

RECRUITING

Instytut Hematologii I Transfuzjologii

Warsaw, 02-776, Poland

RECRUITING

Institutul Clinic Fundeni

Bucharest, 22328, Romania

RECRUITING

Asan Medical Center (AMC)

Seoul, 5505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 6351, South Korea

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 6591, South Korea

RECRUITING

Hospital Universitario Vall D hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitari Germans Trias i Pujol ICO Badalona

Barcelona, 08916, Spain

RECRUITING

Institut Clinic de Nefrologia i Urologia - Hospital Clinic i Provincial de Barcelona

Barcelona, 8036, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Hospital San Joan de Deu Barcelona

Esplugues de Llobregat, 08950, Spain

RECRUITING

Hospital Infantil Universitario Nino Jesus

Madrid, 28009, Spain

RECRUITING

Hospital 12 De Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Regional Universitario de Malaga (Antiguo Carlos Haya)

Málaga, 29010, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, 31008, Spain

RECRUITING

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

RECRUITING

Hospital Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

Karolinska University Hospital Huddinge

Stockholm, 14186, Sweden

RECRUITING

Inselspital Bern

Bern, 3010, Switzerland

RECRUITING

Local Institution - 10850

Leeds, LS9 7TF, United Kingdom

WITHDRAWN

Kings College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

UCL Cancer Institute

London, WC1E 6BT, United Kingdom

RECRUITING

Christie Hospital Nhs Trust

Manchester Withington, M20 4BX, United Kingdom

RECRUITING

Somers Cancer Research Building

Shirley Southampton, SO16 6YD, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 37890149 DERIVED

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Neoplasms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: February 19, 2018
• Study Start: July 19, 2018
• Primary Completion (Estimated): November 30, 2036
• Study Completion (Estimated): November 30, 2036
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

BE (6); CH (1); GB (5); KR (3); IT (10); ES (11); SE (1); AU (1); DE (13); NO (1); NL (3); RO (1); CA (5); US (100); FI (1); JP (12); PL (3); FR (16); IL (4)