Back to resultsStudy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma (ZUMA-22)
Primary Purpose
Relapsed/Refractory Follicular Lymphoma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Axicabtagene Ciloleucel
Cyclophosphamide
Fludarabine
Lenalidomide
Rituximab
Doxorubicin
Vincristine
Prednisone
Bendamustine
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Follicular Lymphoma
Eligibility Criteria
Key Inclusion Criteria:
- Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
- Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy
- Clinical indication for treatment.
- At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
- Adequate renal, hepatic, pulmonary, and cardiac function
Exclusion Criteria:
- Transformed FL
- FL Grade 3b
- Prior CD19-targeted therapy
- Prior CAR therapy or other genetically modified T-cell therapy
- Uncontrolled fungal, bacterial, viral, or other infection
- Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus
- History or presence of a central nervous system (CNS) disorder.
- History of autoimmune disease
- Known history or CNS lymphoma involvement
- Cardiac lymphoma involvement
- History of clinically significant cardiac disease within 6 months of randomization
- Neuropathy greater than Grade 1
- Females who are pregnant or breastfeeding
- Individuals of both genders who are not willing to practice birth control
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Recruiting
- UC Irvine HealthRecruiting
- Stanford Health CareRecruiting
- Colorado Blood Cancer InstituteRecruiting
- Georgetown University Medical Center
- The University of Kansas HospitalRecruiting
- University of Kentucky Medical CenterRecruiting
- University of Maryland Greenebaum Comprehensive Cancer CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- John Theurer Cancer Center at Hackensack University Medical CenterRecruiting
- Columbia University Irving Medical CenterRecruiting
- UPMC Hillman Cancer CenterRecruiting
- Prisma Health - UpstateRecruiting
- Avera Cancer InstituteRecruiting
- TriStar Centennial Medical Center - Cell ProcessingRecruiting
- Henry-Joyce Cancer Clinic
- The University of Texas MD Anderson Cancer CenterRecruiting
- Virginia Commonwealth University
- Hopital Henri MondorRecruiting
- CHU de DijonRecruiting
- Hôpital Claude Huriez-CHU de LilleRecruiting
- Hopital Saint EloiRecruiting
- Hopital Pitie-SalpetriereRecruiting
- Centre Hospitalier Lyon SudRecruiting
- Centre Henri BecquerelRecruiting
- ASST Papa Giovanni XXIIIRecruiting
- Fondazione IRCCS - Istituto Nazionale TumoriRecruiting
- Ospedale San RaffaeleRecruiting
- Arcispedale Santa Maria NuovaRecruiting
- Istituto Clinico Humanitas-IRCCSRecruiting
- Hospital Clinic de BarcelonaRecruiting
- Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet)Recruiting
- Hospital Universitari Vall d'HebrónRecruiting
- Hospital General Universitario Gregorio MaranonRecruiting
- Hospital 12 de OctubreRecruiting
- Hospital Clínico Universitario de ValenciaRecruiting
- University Hospital Birmingham NHS Foundation TrustRecruiting
- University College London Hospitals NHS Foundation TrustRecruiting
- The Royal Marsden NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Axicabtagene Ciloleucel
Standard of Care Therapy
Arm Description
Participants will receive cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV lymphodepletion chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells will be administered.
Participants will receive the investigator's choice of one of the following therapies/dosing schedules: Rituximab plus lenalidomide (R^2) for 12 cycles (28-day cycle) Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m^2 on Day 1, Day 8, Day 15, and Day 22 Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1 Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21 Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle) rituximab 375 mg/m^2 on Day 1 cyclophosphamide 750 mg/m^2 on Day 1 doxorubicin 50 mg/m^2 on Day 1 vincristine 1.4 mg/m^2 (maximum 2 mg) on Day 1 prednisone 40 mg/m^2 on Day 1 through Day 5 Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle) rituximab 375 mg/m^2 on Day 1 bendamustine 90 mg/m^2 on Day 1 and Day 2
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification
PFS is defined as the time from randomization to disease progression or death due to any cause.
Secondary Outcome Measures
Complete Response (CR) Rate as Assessed by Blinded Central Assessment per Lugano Classification
CR rate is defined as the proportion of participants with best overall response of CR during the study prior to any subsequent off-protocol anti-follicular lymphoma (FL) therapy.
Objective Response Rate (ORR) as Assessed by Blinded Central Assessment per Lugano Classification
Objective response rate is defined as the proportion of participants with best overall response of either a complete response or a partial response during the study prior to any subsequent off-protocol anti-FL therapy.
Duration of Response (DOR) as Assessed by Blinded Central Assessment per Lugano Classification
DOR is defined as the time from first objective response to disease progression or death from any cause.
Duration of CR as Assessed by Blinded Central Assessment per Lugano Classification
Duration of CR is defined as the time from first CR to disease progression or death from any cause.
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Event Free Survival (EFS) as Assessed by Blinded Central Assessment per Lugano Classification
EFS is defined as the time from randomization to the earliest date of disease progression, the initiation of subsequent off-protocol anti-FL therapy, or death from any cause.
Time to Next Treatment (TTNT)
TTNT is defined as the time from randomization to the start of new off-protocol anti-FL therapy or death from any cause.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
Change From Baseline in the Global Health Status Quality of Life Scale of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30)
The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.
Change From Baseline in the Physical Functioning Domain of the EORTC QLQ-C30
The EORTC-QLQ-C30) is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.
Change From Baseline in the Global Health Status Quality of Life Scale of the Low Grade Non-Hodgkin Lymphoma-20 (NHL-LG20)
The NHL-LG20 is is a 20-item supplement questionnaire that was specifically developed to assess HRQoL in participants with low-grade non-Hodgkin lymphomas (such as follicular lymphoma). The NHL-LG20 includes multi-item scales of symptom burden, physical condition/fatigue, worries/fears on health and functioning, and emotional impact; and is administered in conjunction with the EORTC QLQ-C30. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales and for the global health status or global HRQoL scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.
Change From Baseline in the Physical Functioning Domain of the NHL-LG20
The NHL-LG20 is is a 20-item supplement questionnaire that was specifically developed to assess HRQoL in participants with low-grade non-Hodgkin lymphomas (such as follicular lymphoma). The NHL-LG20 includes multi-item scales of symptom burden, physical condition/fatigue, worries/fears on health and functioning, and emotional impact; and is administered in conjunction with the EORTC QLQ-C30. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales and for the global health status or global HRQoL scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L)
The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS). Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Changes From Baseline in the Visual Analog Scale (VAS) Scores
The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). Higher scores indicate better health.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05371093
Brief Title
Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
Acronym
ZUMA-22
Official Title
A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
July 2029 (Anticipated)
Study Completion Date
July 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kite, A Gilead Company
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
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
Detailed Description
Five years after the last study participant is randomized, participants who have received axicabtagene ciloleucel will transition to a separate Long-term Follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Follicular Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Axicabtagene Ciloleucel
Arm Type
Experimental
Arm Description
Participants will receive cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV lymphodepletion chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells will be administered.
Arm Title
Standard of Care Therapy
Arm Type
Active Comparator
Arm Description
Participants will receive the investigator's choice of one of the following therapies/dosing schedules:
Rituximab plus lenalidomide (R^2) for 12 cycles (28-day cycle)
Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m^2 on Day 1, Day 8, Day 15, and Day 22
Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1
Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21
Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle)
rituximab 375 mg/m^2 on Day 1
cyclophosphamide 750 mg/m^2 on Day 1
doxorubicin 50 mg/m^2 on Day 1
vincristine 1.4 mg/m^2 (maximum 2 mg) on Day 1
prednisone 40 mg/m^2 on Day 1 through Day 5
Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle)
rituximab 375 mg/m^2 on Day 1
bendamustine 90 mg/m^2 on Day 1 and Day 2
Intervention Type
Biological
Intervention Name(s)
Axicabtagene Ciloleucel
Other Intervention Name(s)
Yescarta®, axi-cel
Intervention Description
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Intervention Description
Administered intravenously
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification
Description
PFS is defined as the time from randomization to disease progression or death due to any cause.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Complete Response (CR) Rate as Assessed by Blinded Central Assessment per Lugano Classification
Description
CR rate is defined as the proportion of participants with best overall response of CR during the study prior to any subsequent off-protocol anti-follicular lymphoma (FL) therapy.
Time Frame
Up to 5 years
Title
Objective Response Rate (ORR) as Assessed by Blinded Central Assessment per Lugano Classification
Description
Objective response rate is defined as the proportion of participants with best overall response of either a complete response or a partial response during the study prior to any subsequent off-protocol anti-FL therapy.
Time Frame
Up to 5 years
Title
Duration of Response (DOR) as Assessed by Blinded Central Assessment per Lugano Classification
Description
DOR is defined as the time from first objective response to disease progression or death from any cause.
Time Frame
Up to 5 years
Title
Duration of CR as Assessed by Blinded Central Assessment per Lugano Classification
Description
Duration of CR is defined as the time from first CR to disease progression or death from any cause.
Time Frame
Up to 5 years
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
Up to 5 years
Title
Event Free Survival (EFS) as Assessed by Blinded Central Assessment per Lugano Classification
Description
EFS is defined as the time from randomization to the earliest date of disease progression, the initiation of subsequent off-protocol anti-FL therapy, or death from any cause.
Time Frame
Up to 5 years
Title
Time to Next Treatment (TTNT)
Description
TTNT is defined as the time from randomization to the start of new off-protocol anti-FL therapy or death from any cause.
Time Frame
Up to 5 years
Title
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame
Randomization up to 5 years plus 30 days
Title
Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
Time Frame
Randomization up to 5 years plus 30 days
Title
Change From Baseline in the Global Health Status Quality of Life Scale of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30)
Description
The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.
Time Frame
Baseline, up to 5 years
Title
Change From Baseline in the Physical Functioning Domain of the EORTC QLQ-C30
Description
The EORTC-QLQ-C30) is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.
Time Frame
Baseline, up to 5 years
Title
Change From Baseline in the Global Health Status Quality of Life Scale of the Low Grade Non-Hodgkin Lymphoma-20 (NHL-LG20)
Description
The NHL-LG20 is is a 20-item supplement questionnaire that was specifically developed to assess HRQoL in participants with low-grade non-Hodgkin lymphomas (such as follicular lymphoma). The NHL-LG20 includes multi-item scales of symptom burden, physical condition/fatigue, worries/fears on health and functioning, and emotional impact; and is administered in conjunction with the EORTC QLQ-C30. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales and for the global health status or global HRQoL scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.
Time Frame
Baseline, up to 5 years
Title
Change From Baseline in the Physical Functioning Domain of the NHL-LG20
Description
The NHL-LG20 is is a 20-item supplement questionnaire that was specifically developed to assess HRQoL in participants with low-grade non-Hodgkin lymphomas (such as follicular lymphoma). The NHL-LG20 includes multi-item scales of symptom burden, physical condition/fatigue, worries/fears on health and functioning, and emotional impact; and is administered in conjunction with the EORTC QLQ-C30. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales and for the global health status or global HRQoL scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.
Time Frame
Baseline, up to 5 years
Title
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L)
Description
The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS). Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Time Frame
Baseline, up to 5 years
Title
Changes From Baseline in the Visual Analog Scale (VAS) Scores
Description
The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). Higher scores indicate better health.
Time Frame
Baseline, up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy
Clinical indication for treatment.
At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
Adequate renal, hepatic, pulmonary, and cardiac function
Exclusion Criteria:
Transformed FL
FL Grade 3b
Prior CD19-targeted therapy
Prior CAR therapy or other genetically modified T-cell therapy
Uncontrolled fungal, bacterial, viral, or other infection
Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus
History or presence of a central nervous system (CNS) disorder.
History of autoimmune disease
Known history or CNS lymphoma involvement
Cardiac lymphoma involvement
History of clinically significant cardiac disease within 6 months of randomization
Neuropathy greater than Grade 1
Females who are pregnant or breastfeeding
Individuals of both genders who are not willing to practice birth control
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Information
Phone
844-454-5483(1-844-454-KITE)
Email
medinfo@kitepharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kite Study Director
Organizational Affiliation
Kite, A Gilead Company
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
The University of Kansas Hospital
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
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 Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
Prisma Health - Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Recruiting
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Name
TriStar Centennial Medical Center - Cell Processing
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry-Joyce Cancer Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Not yet recruiting
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 Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hopital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Claude Huriez-CHU de Lille
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS - Istituto Nazionale Tumori
City
Milano
ZIP/Postal Code
20100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Clinico Humanitas-IRCCS
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet)
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
University Hospital Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=KT-US-473-0133
Description
Gilead Clinical Trials Website
Learn more about this trial
Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
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