Non Hodgkin Lymphoma Clinical Trial

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

Summary

This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL.

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This study is divided into three periods:

Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation;
Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29;
Posttreatment, which includes follow-up assessments for disease status and safety for 2 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zone lymphoma (MZL) histologically confirmed within 6 months of screening, as assessed by local pathology
Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
Follicular lymphoma patients: Received at least one prior line of systemic therapy. Patients that received one prior line of systemic therapy are eligible if they present with high risk features. Patients that received two or more prior lines of systemic therapy are eligible, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2)
Marginal zone lymphoma patients: Received two or more prior lines of systemic therapy, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2) or relapsed after hematopoietic stem cell transplant
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function
Adequate vascular access for leukapheresis procedure

Exclusion Criteria:

Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL
WHO subclassification of duodenal-type FL
Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study)
History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies
Prior CAR T-cell or other genetically-modified cell therapy
History of or active human immunodeficiency virus (HIV)
Active hepatitis B or active hepatitis C
Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment
Active autoimmune disease requiring immunosuppressive therapy
Presence of acute or chronic graft-versus-host=disease
History of significant cardiovascular disease
History or presence of clinically relevant central nervous system pathology
Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

213

Study ID:

NCT04245839

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 37 Locations for this study

See Locations Near You

UCLA Medical Centre-Santa Monica
Santa Monica California, 90095, United States More Info
Sven de Vos, Site 111
Contact
310-829-6192
University Of Colorado Cancer Center
Aurora Colorado, 80045, United States More Info
Manali Kamdar, Site 107
Contact
Yale Cancer Center
New Haven Connecticut, 06520, United States More Info
Iris Isufi, Site 105
Contact
Northwestern University
Chicago Illinois, 60611, United States More Info
Reem Karmali, Site 103
Contact
Illinois Cancer Specialists
Niles Illinois, 60714, United States More Info
Leonard Klein, Site 109
Contact
847-827-9060
University of Maryland - Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States More Info
Saurabh Dahiya, Site 102
Contact
410-328-1230
Massachusetts General Hospital - Dana-Farber Cancer Institute
Boston Massachusetts, 02114, United States More Info
Jeremy Abramson, Site 100
Contact
617-571-3037
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States More Info
Jon Arnason, Site 101
Contact
617-667-9235
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Maria Palomba, Site 116
Contact
212-639-2000
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States More Info
Alan Skarbnik, Site 110
Contact
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Brian Hill, Site 112
Contact
216-445-9451
Providence Cancer Center/Earle A. Chiles Res. Inst.
Portland Oregon, 97213, United States More Info
John Godwin, Site 114
Contact
503-215-5696
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia Pennsylvania, 19104, United States More Info
Stephen Schuster, Site 117
Contact
215-614-1843
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States More Info
Vinod Parameswaran, Site 113
Contact
605-322-3035
The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Loretta Nastoupil, Site 104
Contact
713-745-8145
University Of Virginia Health System
Charlottesville Virginia, 22903, United States More Info
Indumathy Varadarajan, Site 115
Contact
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States More Info
Alexandre Hirayama, Site 108
Contact
Local Institution - 450
Wien , 1090, Austria More Info
Site 450
Contact
Local Institution - 150
Toronto Ontario, M5G 2, Canada More Info
Site 150
Contact
Local Institution - 151
Montreal Quebec, H1T 2, Canada More Info
Site 151
Contact
Local Institution - 252
Lille , 59037, France More Info
Site 252
Contact
Local Institution - 251
Montpellier CEDEX 5 , 34295, France More Info
Site 251
Contact
Local Institution - 250
Pierre-Benite CEDEX , 69495, France More Info
Site 250
Contact
Local Institution - 501
Koeln , 50937, Germany More Info
Site 501
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Local Institution - 502
Munich , 81377, Germany More Info
Site 502
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Local Institution - 500
Ulm , 89081, Germany More Info
Site 500
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Local Institution - 300
Bergamo , 24127, Italy More Info
Site 300
Contact
Local Institution - 301
Naples , 80131, Italy More Info
Site 301
Contact
Local Institution - 550
Chuo-ku Tokyo, 104-0, Japan More Info
Site 550
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Local Institution - 552
Fukuoka , 812-8, Japan More Info
Site 552
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Local Institution - 551
Minato-ku , 105-8, Japan More Info
Site 551
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Local Institution - 553
Sapporo, Hokkaidô , 060-8, Japan More Info
Site 553
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Local Institution - 350
Salamanca , 37007, Spain More Info
Site 350
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Local Institution - 351
Sevilla , 41013, Spain More Info
Site 351
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Local Institution - 600
Stockholm , 14186, Sweden More Info
Site 600
Contact
Local Institution - 200
London , NW1 2, United Kingdom More Info
Site 200
Contact
Local Institution - 201
Manchester , M20 4, United Kingdom More Info
Site 201
Contact

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

213

Study ID:

NCT04245839

Recruitment Status:

Recruiting

Sponsor:


Celgene

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