Back to resultsA Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) (TRANSCEND FL)
Primary Purpose
Lymphoma, Non-Hodgkin
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fludarabine
Cyclophosphamide
JCAR017
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring B-cell Non-Hodgkin Lymphoma (NHL), JCAR017, Relapsed or Refractory, Follicular Lymphoma, Marginal Zone Lymphoma
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
Sites / Locations
- UCLA Medical Centre-Santa MonicaRecruiting
- University Of Colorado Cancer CenterRecruiting
- Yale Cancer CenterRecruiting
- Northwestern UniversityRecruiting
- Illinois Cancer SpecialistsRecruiting
- University of Maryland - Greenebaum Comprehensive Cancer CenterRecruiting
- Massachusetts General Hospital - Dana-Farber Cancer InstituteRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Novant Health Presbyterian Medical CenterRecruiting
- Cleveland Clinic FoundationRecruiting
- Providence Cancer Center/Earle A. Chiles Res. Inst.Recruiting
- University of Pennsylvania - Perelman Center for Advanced MedicineRecruiting
- Avera Cancer InstituteRecruiting
- The University of Texas - MD Anderson Cancer CenterRecruiting
- University Of Virginia Health SystemRecruiting
- Fred Hutchinson.Cancer CenterRecruiting
- Local Institution - 450Recruiting
- Local Institution - 150Recruiting
- Local Institution - 151Recruiting
- Local Institution - 252Recruiting
- Local Institution - 251Recruiting
- Local Institution - 250Recruiting
- Local Institution - 501Recruiting
- Local Institution - 502Recruiting
- Local Institution - 500Recruiting
- Local Institution - 300Recruiting
- Local Institution - 301Recruiting
- Local Institution - 553Recruiting
- Local Institution - 550Recruiting
- Local Institution - 552Recruiting
- Local Institution - 551Recruiting
- Local Institution - 350Recruiting
- Local Institution - 351Recruiting
- Local Institution - 600Recruiting
- Local Institution - 200Recruiting
- Local Institution - 201Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Administration of JCAR017
Arm Description
Subjects will be treated with fludarabine IV (30 mg/m2/day for 3 days) and cyclophosphamide IV (300 mg/m2/day for 3 days) prior to JCAR017 infusion. Refer to the most recent package inserts for further details on administration of these agents. JCAR017 will be infused on Day 1 at a target dose of 100 × 10^6 CAR-positive viable T cells (CAR+ T cells), 2 to 7 days after completion of LD chemotherapy. Each JCAR017 dose includes CD4+ CAR+ T cells and CD8+ CAR+ T cells.
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
Is defined as the percentage of participants achieving either a partial response (PR) or complete response (CR) at any time up to 60 months after JCAR017 treatment as assessed by PET-CT and/or CT using "The Lugano classification"
Secondary Outcome Measures
Complete response rate (CRR) as assessed but PET-CT and/or CT using "The Lugano Classification"
Is defined as the percentage of subjects achieving a CR at any time up to 60 months after JCAR017 treatment
Duration of Response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using "The Lugano Classification"
is defined for subjects with a BOR of CR as the time from first response (CR or PR) to disease progression or death from any cause up to 60 months after JCAR017 treatment
Duration of Response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification"
is defined as the time from first response (CR or PR) to disease progression or death from any cause, whichever occurs first up to 60 months after JCAR017 treatment
Progression-Free Survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification"
is defined as the time from start of JCAR017 to disease progression or death from any cause, whichever occurs first up to 60 months after JCAR017 treatment
Overall Survival (OS)
is defined as the time from start of JCAR017 to time of death due to any cause up to 60 months after JCAR017 treatment
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Pharmacokinetics - Cmax
Maximum concentration
Pharmacokinetics - Tmax
Time to maximum concentration
Pharmacokinetics - AUC
Area under the curve
European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30)
is questionnaire that will be used as a measure of health-related quality of life.
The EORTC QLQ-C30 is composed of both multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.
Functionality Assessment of Cancer Therapy Lymphoma Subscale (FACT-LymS)
is a 15-item lymphoma-specific additional concerns subscale. This subscale addresses symptoms and functional limitations are important to lymphoma patients. The FACT-LymS items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. High scores indicate lower symptom burden.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04245839
Brief Title
A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
Acronym
TRANSCEND FL
Official Title
A Phase 2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
September 28, 2028 (Anticipated)
Study Completion Date
September 28, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
B-cell Non-Hodgkin Lymphoma (NHL), JCAR017, Relapsed or Refractory, Follicular Lymphoma, Marginal Zone Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
213 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Administration of JCAR017
Arm Type
Experimental
Arm Description
Subjects will be treated with fludarabine IV (30 mg/m2/day for 3 days) and cyclophosphamide IV (300 mg/m2/day for 3 days) prior to JCAR017 infusion. Refer to the most recent package inserts for further details on administration of these agents.
JCAR017 will be infused on Day 1 at a target dose of 100 × 10^6 CAR-positive viable T cells (CAR+ T cells), 2 to 7 days after completion of LD chemotherapy. Each JCAR017 dose includes CD4+ CAR+ T cells and CD8+ CAR+ T cells.
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Fludarabine
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
JCAR017
Intervention Description
JCAR017
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Is defined as the percentage of participants achieving either a partial response (PR) or complete response (CR) at any time up to 60 months after JCAR017 treatment as assessed by PET-CT and/or CT using "The Lugano classification"
Time Frame
Up to 60 months
Secondary Outcome Measure Information:
Title
Complete response rate (CRR) as assessed but PET-CT and/or CT using "The Lugano Classification"
Description
Is defined as the percentage of subjects achieving a CR at any time up to 60 months after JCAR017 treatment
Time Frame
Up to 60 months
Title
Duration of Response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using "The Lugano Classification"
Description
is defined for subjects with a BOR of CR as the time from first response (CR or PR) to disease progression or death from any cause up to 60 months after JCAR017 treatment
Time Frame
Up to 60 months
Title
Duration of Response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification"
Description
is defined as the time from first response (CR or PR) to disease progression or death from any cause, whichever occurs first up to 60 months after JCAR017 treatment
Time Frame
Up to 60 months
Title
Progression-Free Survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification"
Description
is defined as the time from start of JCAR017 to disease progression or death from any cause, whichever occurs first up to 60 months after JCAR017 treatment
Time Frame
Up to 60 months
Title
Overall Survival (OS)
Description
is defined as the time from start of JCAR017 to time of death due to any cause up to 60 months after JCAR017 treatment
Time Frame
Up to 60 months
Title
Adverse Events (AEs)
Description
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Time Frame
Up to 60 months
Title
Pharmacokinetics - Cmax
Description
Maximum concentration
Time Frame
Up to 60 months
Title
Pharmacokinetics - Tmax
Description
Time to maximum concentration
Time Frame
Up to 60 months
Title
Pharmacokinetics - AUC
Description
Area under the curve
Time Frame
Up to 60 months
Title
European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30)
Description
is questionnaire that will be used as a measure of health-related quality of life.
The EORTC QLQ-C30 is composed of both multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.
Time Frame
Up to 24 months
Title
Functionality Assessment of Cancer Therapy Lymphoma Subscale (FACT-LymS)
Description
is a 15-item lymphoma-specific additional concerns subscale. This subscale addresses symptoms and functional limitations are important to lymphoma patients. The FACT-LymS items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. High scores indicate lower symptom burden.
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Medical Centre-Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven de Vos, Site 111
Phone
310-829-6192
Facility Name
University Of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manali Kamdar, Site 107
Phone
720-848-0752
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris Isufi, Site 105
Phone
203-688-4242
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reem Karmali, Site 103
Phone
312-695-0990
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonard Klein, Site 109
Phone
847-827-9060
Facility Name
University of Maryland - Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Rapoport, Site 102
Phone
410-328-1230
Facility Name
Massachusetts General Hospital - Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Abramson, Site 100
Phone
617-726-5130
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Arnason, Site 101
Phone
617-667-9235
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Palomba, Site 116
Phone
212-639-2000
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Skarbnik, Site 110
Phone
704-316-3297
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Hill, Site 112
Phone
216-445-9451
Facility Name
Providence Cancer Center/Earle A. Chiles Res. Inst.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy Lewis, Site 114
Phone
503-216-6300
Facility Name
University of Pennsylvania - Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Schuster, Site 117
Phone
267-804-4081
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinod Parameswaran, Site 113
Phone
605-322-3035
Facility Name
The University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loretta Nastoupil, Site 104
Phone
713-745-4017
Facility Name
University Of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Indumathy Varadarajan, Site 115
Phone
434-924-9333
Facility Name
Fred Hutchinson.Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Hirayama, Site 108
Phone
206-667-5616
Facility Name
Local Institution - 450
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 450
Facility Name
Local Institution - 150
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 150
Facility Name
Local Institution - 151
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 151
Facility Name
Local Institution - 252
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 252
Facility Name
Local Institution - 251
City
Montpellier CEDEX 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 251
Facility Name
Local Institution - 250
City
Pierre-Benite CEDEX
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 250
Facility Name
Local Institution - 501
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 501
Facility Name
Local Institution - 502
City
Munich
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 502
Facility Name
Local Institution - 500
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 500
Facility Name
Local Institution - 300
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 300
Facility Name
Local Institution - 301
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 301
Facility Name
Local Institution - 553
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 553
Facility Name
Local Institution - 550
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 550
Facility Name
Local Institution - 552
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 552
Facility Name
Local Institution - 551
City
Minato-ku
ZIP/Postal Code
105-8470
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 551
Facility Name
Local Institution - 350
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 350
Facility Name
Local Institution - 351
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 351
Facility Name
Local Institution - 600
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 600
Facility Name
Local Institution - 200
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 200
Facility Name
Local Institution - 201
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 201
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
Learn more about this 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)
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