Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies
Official Title
An Evaluation of the Toxicity and Therapeutic Effects of Epstein-Barr Virus-Immune T-Lymphocytes Derived From a Normal HLA-Compatible or Haplotype-Matched Donor in the Treatment of EBV-Associated Lymphoproliferative Diseases or Malignancies and Patients With Detectable Circulating Levels of EBV DNA Who Are at High Risk for EBV-Associated Lymphoproliferative Diseases
Acronym
Not provided
Organization
Atara BiotherapeuticsINDUSTRY
Status Module
Record Verification Date
Jan 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT02822495No longer available
Start Date
Mar 1995Actual
Primary Completion Date
Jul 2019Actual
Completion Date
Jul 2019Actual
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 21, 2022
Results First Submitted that Met QC Criteria
Jan 18, 2023
Results First Posted Date
Feb 13, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 21, 2020
Certification/Extension First Submitted that Passed QC Review
Jul 21, 2020
Certification/Extension First Posted Date
Jul 23, 2020Actual
Last Update Submitted Date
Jan 18, 2023
Last Update Posted Date
Feb 13, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Atara BiotherapeuticsINDUSTRY
Collaborators
Name
Class
Memorial Sloan Kettering Cancer Center
OTHER
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this phase I/II trial is to study the side effects and best dose of biological therapy to treat patients at high-risk or with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.
Detailed Description
Not provided
Conditions Module
Conditions
EBV-induced Lymphomas
EBV-associated Malignancies
Transplant Patients With EBV Viremia at High Risk of Developing a Recurrent EBV Lymphoma
Keywords
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
childhood Burkitt lymphoma
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
58Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
Experimental
Patients with Epstein-Barr virus positive (EBV+) posttransplant lymphoproliferative disorders (PTLD) following hematopoietic cell transplant (HCT) who were relapse/refractory (R/R) to rituximab will receive IV infusion of tabelecleucel (tab-cel) at 1-5 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
Patients with EBV+ PTLD following solid organ transplant (SOT) who were R/R to rituximab and chemotherapy will receive IV infusion of tabelecleucel at 1-5 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
EBV+ AID-LPD (Tab-cel Only)
Experimental
Patients with EBV+ acquired immunodeficiency (AID) lymphoproliferative disorder (LPD) will receive IV infusion of tabelecleucel at 1-5 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
EBV+ LMS (Tab-cel Only)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
Biological
EBV-CTLs are cytotoxic T lymphocytes that specifically kill cells presenting EBV protein antigens including EBV-transformed B lymphocytes responsible for EBV-associated lymphomas and lymphoproliferative disorders.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR)
The ORR is defined as percentage of participants with best overall response of complete remission/response (CR) or partial remission/response (PR) based on investigator's assessment. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR is complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel; and PR is a 50 % or greater reduction in the size of all lymphomatous lesions as determined by computed tomography (CT) or magnetic resonance imaging (MRI) measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR is clearance of EBV without subsequent development of EBV+ LPD; and PR is at least a 10-fold decrease in EBV DNA levels.
From Day 1 through 251.1 months after Day 1 dose
Secondary Outcomes
Measure
Description
Time Frame
Overall Survival (OS)
The OS is defined as the time from the first dose of tabelecleucel or EBV-CTLs to the date of death due to any cause. The OS was estimated using Kaplan-Meier method.
From Day 1 through 251.1 months after Day 1 dose
OS Rate at 12 Months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Pathologically documented EBV antigen positive lymphoproliferative disease, lymphoma, or other EBV-associated malignancy OR
Severely immunocompromised patients who develop blood levels of EBV DNA exceeding 500 copies/ml DNA, and are therefore at high risk for developing an EBV LPD
It is expected that five types of patients afflicted with EBV-associated lymphomas or lymphoproliferative diseases will be referred and will consent to participate in this trial. These are:
Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders following an allogeneic marrow transplant.
Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders following an allogeneic organ transplant.
Patients with AIDS developing EBV lymphomas or lymphoproliferative diseases as a consequence of the profound acquired immunodeficiency induced by HIV.
Patients who develop EBV lymphomas or lymphoproliferative diseases as a consequence of profound immunodeficiencies associated with a congenital immune deficit or acquired as a sequela of anti-neoplastic or immunosuppressive therapy.
Patients who develop other EBV-associated malignancies without pre-existing immune deficiency, including: EBV+ Hodgkin's and Non- Hodgkin's disease, EBV+ nasopharyngeal carcinoma, EBV+ hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma.
Exclusion Criteria:
The following patients will be excluded from this study:
Moribund patients who, by virtue of heart, kidney, liver, lung, or neurologic dysfunction not related to lymphoma, are unlikely to survive the 6-8 weeks required for in vitro generation and expansion of the EBV-specific T cells to be used for therapy and the subsequent 3 weeks required to achieve an initial assessment of the effects of infusions of EBV-specific T cells.
Pregnancy does not constitute a contraindication to infusions of EBV-specific T cells.
Prockop S, Doubrovina E, Suser S, Heller G, Barker J, Dahi P, Perales MA, Papadopoulos E, Sauter C, Castro-Malaspina H, Boulad F, Curran KJ, Giralt S, Gyurkocza B, Hsu KC, Jakubowski A, Hanash AM, Kernan NA, Kobos R, Koehne G, Landau H, Ponce D, Spitzer B, Young JW, Behr G, Dunphy M, Haque S, Teruya-Feldstein J, Arcila M, Moung C, Hsu S, Hasan A, O'Reilly RJ. Off-the-shelf EBV-specific T cell immunotherapy for rituximab-refractory EBV-associated lymphoma following transplantation. J Clin Invest. 2020 Feb 3;130(2):733-747. doi: 10.1172/JCI121127.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 58 participants were treated. However, 1 participant was analyzed in 2 different arms due to treatment. This participant was counted in only 1 arm for Participant Flow results and was counted in each arm for Outcome Measures.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
Participants with Epstein-Barr virus positive (EBV+) posttransplant lymphoproliferative disorders (PTLD) hematopoietic cell transplant (HCT) who were relapse/refractory (R/R) to rituximab received IV infusion of tabelecleucel (Tab-cel) on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 14, 2018
Jul 20, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
stage II childhood Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse large cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage I adult lymphoblastic lymphoma
stage I adult Burkitt lymphoma
T-cell large granular lymphocyte leukemia
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
recurrent adult T-cell leukemia/lymphoma
AIDS-related peripheral/systemic lymphoma
HIV-associated Hodgkin lymphoma
stage I childhood small noncleaved cell lymphoma
stage I childhood large cell lymphoma
stage II childhood small noncleaved cell lymphoma
stage II childhood large cell lymphoma
stage III childhood small noncleaved cell lymphoma
stage III childhood large cell lymphoma
stage IV childhood small noncleaved cell lymphoma
stage IV childhood large cell lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
stage I mantle cell lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II mantle cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult Burkitt lymphoma
contiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome
contiguous stage II small lymphocytic lymphoma
contiguous stage II marginal zone lymphoma
noncontiguous stage II small lymphocytic lymphoma
noncontiguous stage II marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage I marginal zone lymphoma
stage I small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Patients with EBV+ leiomyosarcoma (LMS) will receive IV infusion of tabelecleucel at 1-5 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
EBV+ NPC (Tab-cel Only)
Experimental
Patients with EBV+ nasopharyngeal carcinoma (NPC) will receive IV infusion of tabelecleucel at 1-5 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
Experimental
Patients with EBV+ following PTLD HCT who were R/R to rituximab or rituximab naive will receive IV infusion of transplant donor-derived EBV-cytotoxic T lymphocytes (CTLs) at 1-5 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
Patients with EBV+ PTLD following SOT who were R/R to rituximab and chemotherapy will receive IV infusion of transplant donor-derived EBV-CTLs at 1-5 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
EBV+ Viremia (EBV-CTLs Only)
Experimental
Patients with EBV+ viremia will receive IV infusion of transplant donor-derived EBV-CTLs at 1-5 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
EBV+ PID-LPD (Tab-cel or EBV-CTLs)
Experimental
Patients with EBV+ primary immunodeficiency (PID) LPD will receive IV infusion of tabelecleucel or transplant donor-derived EBV- CTLs at 1-5 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
EBV+ Lymphoma (Tab-cel or EBV-CTLs)
Experimental
Patients with EBV+ lymphoma will receive IV infusion of tabelecleucel or transplant donor-derived EBV-CTLs at 1-5 × 10^6 T-cells/kg on Days 1, 8, and 15 and will be observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
Percentage of participants with OS at 12 months are reported. The OS is defined as the time from the first dose of tabelecleucel or EBV-CTLs to the date of death due to any cause. The OS was estimated using Kaplan-Meier method.
From Day 1 through 12 months after Day 1 dose
OS Follow-up Time
The OS at follow-up time are reported. The OS is defined as the time from the first dose of tabelecleucel or EBV-CTLs to the date of death due to any cause. The OS was estimated using Kaplan-Meier method.
From Day 1 through 251.1 months after Day 1 dose
Time to Response (TTR)
The TTR was defined as the time from the date of the first dose of tabelecleucel or EBV-CTLs to the date of a PR or CR, whichever occurred first. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR was defined as complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel or EBV-CTLs; and a PR was defined as a 50 % or greater reduction in the size of all lymphomatous lesions as determined by CT or MRI scan measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel or EBV-CTLs. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR was defined as clearance of EBV without subsequent development of EBV+ LPD; and PR was defined as at least a 10-fold decrease in EBV DNA levels.
From Day 1 through 251.1 months after Day 1 dose
Clinical Benefit Rate (CBR)
The CBR was the proportion of participants who have achieved a CR, PR or SD assessed at least 28 days after first dose date of study drug. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR as complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel or EBVCTLs; and a PR as a >= 50% reduction in size of all lymphomatous lesions as determined by CT or MRI scan measurements of tumor volume, maintained for at least 3 weeks following completion of a cycle of tabelecleucel or EBV-CTLs. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR as clearance of EBV without subsequent development of EBV+ LPD; and PR as at least a 10-fold decrease in EBV DNA levels. The CBR was included specifically as clinically meaningful for solid tumor, namely LMS.
Participants with EBV+PTLD solid organ transplant (SOT) who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
FG002
EBV+ AID-LPD (Tab-cel Only)
Participants with EBV+ acquired immunodeficiency (AID) lymphoproliferative disorder (LPD) received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
FG003
EBV+ LMS (Tab-cel Only)
Participants with EBV+ leiomyosarcoma (LMS) received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
FG004
EBV+ NPC (Tab-cel Only)
Participants with EBV+ nasopharyngeal carcinoma (NPC) received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
FG005
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
Participants with EBV+PTLD HCT who were R/R to rituximab or rituximab naive received donor-derived EBV cytotoxic T lymphocyte (CTL) on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+PTLD SOT received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
FG007
EBV+ Viremia (EBV-CTLs Only)
Participants with EBV+ viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
FG008
EBV+PID-LPD (Tab-cel or EBV-CTLs Only)
Participants with EBV+ primary immunodeficiency (PID) LPD received IV infusion of tabelecleucel or donor-derived EBV- CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
FG009
EBV+ Lymphoma (Tab-cel or EBV-CTLs Only)
Participants with EBV+ lymphoma received IV infusion of tabelecleucel or donor-derived EBV- CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
FG00011 subjects
FG0014 subjects
FG0022 subjects
FG0035 subjects
FG0041 subjects
FG00523 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
FG0092 subjects
COMPLETED
FG0004 subjects
FG0012 subjects
FG0021 subjects
FG0033 subjects
FG0040 subjects
FG0058 subjects
FG0061 subjects
FG0074 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0007 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG0041 subjects
FG00515 subjects
FG0061 subjects
FG0072 subjects
FG0082 subjects
FG0092 subjects
Type
Comment
Reasons
Death
FG0004 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG00513 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0091 subjects
Lost to Follow-up
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Full analysis set included all participants who received at least one dose of study treatment (tabelecleucel or EBV-CTLs). Results from arms with <= 3 participants (as shown in the participant flow) are being excluded due to the low numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications of this single center study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
Participants with EBV+ PTLD HCT who were R/R to rituximab received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+PTLD SOT who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
BG002
EBV+ LMS (Tab-cel Only)
Participants with EBV+ LMS received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
BG003
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
Participants with EBV+PTLD HCT who were R/R to rituximab or rituximab naive received donor-derived EBV-CTL on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
BG004
EBV+ Viremia (EBV-CTLs Only)
Participants with EBV+ viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG0014
BG0025
BG00323
BG0047
BG00550
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
<18 years
Title
Measurements
BG0007
BG0013
BG0024
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Objective Response Rate (ORR)
The ORR is defined as percentage of participants with best overall response of complete remission/response (CR) or partial remission/response (PR) based on investigator's assessment. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR is complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel; and PR is a 50 % or greater reduction in the size of all lymphomatous lesions as determined by computed tomography (CT) or magnetic resonance imaging (MRI) measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR is clearance of EBV without subsequent development of EBV+ LPD; and PR is at least a 10-fold decrease in EBV DNA levels.
Full analysis set included all participants who received at least one dose of study treatment (tabelecleucel or EBV-CTLs). Results from arms with <= 3 participants (as shown in the participant flow) are excluded due to the low numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications of this single center study.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through 251.1 months after Day 1 dose
ID
Title
Description
OG000
EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
Participants with EBV+ PTLD following HCT who were R/R to rituximab received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+PTLD following SOT who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG002
EBV+ LMS (Tab-cel Only)
Participants with EBV+ following LMS received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG003
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
Participants with EBV+PTLD following HCT who were R/R to rituximab or rituximab naive received donor-derived EBV-CTL on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG004
EBV+ Viremia (EBV-CTLs Only)
Participants with EBV+ following viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00011
OG0014
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG00063.6(30.8 to 89.1)
OG00150.0(6.8 to 93.2)
OG0020(0 to 52.2)
OG003
Secondary
Overall Survival (OS)
The OS is defined as the time from the first dose of tabelecleucel or EBV-CTLs to the date of death due to any cause. The OS was estimated using Kaplan-Meier method.
Full analysis set included all participants who received at least one dose of study treatment (tabelecleucel or EBV-CTLs). Results from arms with <= 3 participants (as shown in the participant flow) are excluded due to the low numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications of this single center study.
Posted
Median
95% Confidence Interval
Months
From Day 1 through 251.1 months after Day 1 dose
ID
Title
Description
OG000
EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
Participants with EBV+ PTLD following HCT who were R/R to rituximab received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+PTLD following SOT who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Secondary
OS Rate at 12 Months
Percentage of participants with OS at 12 months are reported. The OS is defined as the time from the first dose of tabelecleucel or EBV-CTLs to the date of death due to any cause. The OS was estimated using Kaplan-Meier method.
Full analysis set included all participants who received at least one dose of study treatment (tabelecleucel or EBV-CTLs). Results from arms with <= 3 participants (as shown in the participant flow) are excluded due to the low numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications of this single center study.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through 12 months after Day 1 dose
ID
Title
Description
OG000
EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
Participants with EBV+ PTLD following HCT who were R/R to rituximab received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+PTLD following SOT who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Secondary
OS Follow-up Time
The OS at follow-up time are reported. The OS is defined as the time from the first dose of tabelecleucel or EBV-CTLs to the date of death due to any cause. The OS was estimated using Kaplan-Meier method.
Full analysis set included all participants who received at least one dose of study treatment (tabelecleucel or EBV-CTLs). Results from arms with <= 3 participants (as shown in the participant flow) are excluded due to the low numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications of this single center study.
Posted
Median
Full Range
Months
From Day 1 through 251.1 months after Day 1 dose
ID
Title
Description
OG000
EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
Participants with EBV+ PTLD following HCT who were R/R to rituximab received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+PTLD following SOT who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Secondary
Time to Response (TTR)
The TTR was defined as the time from the date of the first dose of tabelecleucel or EBV-CTLs to the date of a PR or CR, whichever occurred first. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR was defined as complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel or EBV-CTLs; and a PR was defined as a 50 % or greater reduction in the size of all lymphomatous lesions as determined by CT or MRI scan measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel or EBV-CTLs. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR was defined as clearance of EBV without subsequent development of EBV+ LPD; and PR was defined as at least a 10-fold decrease in EBV DNA levels.
Full analysis set included all participants who received at least one dose of study treatment (tabelecleucel or EBV-CTLs). Participants who achieved CR or PR were analyzed for this outcome measure. Results from arms with <= 3 participants (as shown in the participant flow) are excluded due to the low numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications of this single center study.
Posted
Median
Full Range
Months
From Day 1 through 251.1 months after Day 1 dose
ID
Title
Description
OG000
EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
Participants with EBV+ PTLD following HCT who were R/R to rituximab received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Secondary
Clinical Benefit Rate (CBR)
The CBR was the proportion of participants who have achieved a CR, PR or SD assessed at least 28 days after first dose date of study drug. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR as complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel or EBVCTLs; and a PR as a >= 50% reduction in size of all lymphomatous lesions as determined by CT or MRI scan measurements of tumor volume, maintained for at least 3 weeks following completion of a cycle of tabelecleucel or EBV-CTLs. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR as clearance of EBV without subsequent development of EBV+ LPD; and PR as at least a 10-fold decrease in EBV DNA levels. The CBR was included specifically as clinically meaningful for solid tumor, namely LMS.
Full analysis set included all participants who received at least one dose of study treatment (tabelecleucel or EBV-CTLs). Participants who achieved CR, PR or SD were analyzed for this outcome measure. Results from arms with <= 3 participants (as shown in the participant flow) are excluded due to the low numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications of this single center study.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through 251.1 months after Day 1 dose
ID
Title
Description
OG000
EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
Participants with EBV+ PTLD following HCT who were R/R to rituximab received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Time Frame
From Day 1 through 251.1 months after Day 1 dose
Description
Combined AE data for all enrolled participants are reported because few arms had <=3 participants which poses a risk of participant identification with rare indications in this study. Treatment-emergent SAEs includes events collected retrospectively and prospectively per protocol. Non-serious AEs were not collected, hence reported as '0'. In participant flow, 'Deaths' are reported as a reason for study discontinuation, whereas in 'All-Cause Mortality' deaths due to any cause are reported.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Overall Total
All eligible participants with EBV+ received IV infusion of tabelecleucel or donor-derived EBV-CTL on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
32
58
40
58
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0004 events3 affected58 at risk
Haemolysis
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events1 affected58 at risk
Left ventricular dysfunction
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events2 affected58 at risk
Pericardial effusion
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Pericarditis
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Sinus bradycardia
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Ventricular arrhythmia
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Hypopituitarism
Endocrine disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0003 events3 affected58 at risk
Anal ulcer
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Ascites
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Colitis
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Haematochezia
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Nausea
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Odynophagia
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Stomatitis
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events2 affected58 at risk
Device related thrombosis
General disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Disease progression
General disorders
MedDRA (22.0)
Systematic Assessment
EG0004 events3 affected58 at risk
Oedema
General disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events2 affected58 at risk
Pyrexia
General disorders
MedDRA (22.0)
Systematic Assessment
EG00014 events13 affected58 at risk
Cholecystitis
Hepatobiliary disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Hepatic failure
Hepatobiliary disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events2 affected58 at risk
Hypersensitivity
Immune system disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events2 affected58 at risk
Renal transplant failure
Immune system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Serum sickness
Immune system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Device related infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0009 events8 affected58 at risk
Ear infection bacterial
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Ear infection staphylococcal
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Escherichia urinary tract infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Gastroenteritis rotavirus
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Gastrointestinal viral infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0005 events4 affected58 at risk
Neutropenic infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0004 events3 affected58 at risk
Otitis media
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Paronychia
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Pharyngitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0002 events2 affected58 at risk
Pneumonia
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Pneumonia fungal
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Sinusitis bacterial
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Staphylococcal infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Blood bilirubin increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0002 events2 affected58 at risk
Blood creatine phosphokinase increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Blood creatinine increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Electrocardiogram QT prolonged
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Neutrophil count decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0004 events3 affected58 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Kaposi's sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Non-Hodgkin's lymphoma recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Cerebral haemorrhage
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Depressed level of consciousness
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0003 events1 affected58 at risk
Intracranial pressure increased
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Nervous system disorder
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Neuralgia
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Peripheral motor neuropathy
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events2 affected58 at risk
Seizure
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0003 events3 affected58 at risk
Mental status changes
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Renal failure
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0003 events3 affected58 at risk
Urinary retention
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0003 events3 affected58 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0007 events5 affected58 at risk
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events2 affected58 at risk
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0005 events3 affected58 at risk
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events1 affected58 at risk
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Embolism
Vascular disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Haemorrhage
Vascular disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Hypertension
Vascular disorders
MedDRA (22.0)
Systematic Assessment
EG0001 events1 affected58 at risk
Hypotension
Vascular disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events2 affected58 at risk
Venoocclusive disease
Vascular disorders
MedDRA (22.0)
Systematic Assessment
EG0002 events1 affected58 at risk
Other Adverse Events
Not provided
In this investigator-led study, scans were only collected as clinically indicated in lieu of a defined schedule; therefore, disease assessment endpoints (duration of response, durable response rate, progression-free survival, time to progression) may not be reliable, hence not reported. Study 95-024 was designed for patient treatment and conducted mostly as investigator-sponsored, single-center until Atara assumed responsibility, then relevant data was transferred from the investigator to Atara.
Participants with EBV+ following LMS received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG003
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
Participants with EBV+PTLD following HCT who were R/R to rituximab or rituximab naive received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG004
EBV+ Viremia (EBV-CTLs Only)
Participants with EBV+ following viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00011
OG0014
OG0025
OG00323
OG0047
Title
Denominators
Categories
Title
Measurements
OG00014.8(0.9 to NA)Upper limit of confidence interval is not estimable due to insufficient events being observed at the time of the analysis.
OG00184.8(1.1 to 115.0)
OG002NA(60.6 to NA)Median and upper limit of confidence interval are not estimable due to insufficient events being observed at the time of the analysis.
OG00318.6(1.5 to NA)Upper limit of confidence interval is not estimable due to insufficient events being observed at the time of the analysis.
OG004NA(2.5 to NA)Median and upper limit of confidence interval are not estimable due to insufficient events being observed at the time of the analysis.
OG002
EBV+ LMS (Tab-cel Only)
Participants with EBV+ following LMS received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG003
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
Participants with EBV+PTLD following HCT who were R/R to rituximab or rituximab naive received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG004
EBV+ Viremia (EBV-CTLs Only)
Participants with EBV+ following viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00011
OG0014
OG0025
OG00323
OG0047
Title
Denominators
Categories
Title
Measurements
OG00054.5(22.9 to 78.0)
OG00175.0(12.8 to 96.1)
OG002100.0(100 to 100)
OG00352.2(30.5 to 70.0)
OG00485.7(33.4 to 97.9)
OG002
EBV+ LMS (Tab-cel Only)
Participants with EBV+ following LMS received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG003
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
Participants with EBV+PTLD following HCT who were R/R to rituximab or rituximab naive received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG004
EBV+ Viremia (EBV-CTLs Only)
Participants with EBV+ following viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+PTLD following SOT who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG002
EBV+ LMS (Tab-cel Only)
Participants with EBV+ following LMS received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG003
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
Participants with EBV+PTLD following HCT who were R/R to rituximab or rituximab naive received donor-derived EBV-CTL on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG004
EBV+ Viremia (EBV-CTLs Only)
Participants with EBV+ following viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+PTLD following SOT who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG002
EBV+ LMS (Tab-cel Only)
Participants with EBV+ following LMS received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG003
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
Participants with EBV+PTLD following HCT who were R/R to rituximab or rituximab naive received donor-derived EBV-CTL on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
OG004
EBV+ Viremia (EBV-CTLs Only)
Participants with EBV+ following viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.