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NCT00002663 · REGISTRY CONDITION SEARCH

Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2023-02-13

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

OS Rate at 12 Months

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outcome · POSTED

OS Follow-up Time

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outcome · POSTED

Time to Response (TTR)

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outcome · POSTED

Clinical Benefit Rate (CBR)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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: 1. Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders following an allogeneic marrow transplant. 2. Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders following an allogeneic organ transplant. 3. Patients with AIDS developing EBV lymphomas or lymphoproliferative diseases as a consequence of the profound acquired immunodeficiency induced by HIV. 4. 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. 5. 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.
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
    label
    EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
    label
    EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only)
    type
    EXPERIMENTAL
  3. description
    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.
    intervention Names
    1. Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
    label
    EBV+ AID-LPD (Tab-cel Only)
    type
    EXPERIMENTAL
  4. description
    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.
    intervention Names
    1. Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
    label
    EBV+ LMS (Tab-cel Only)
    type
    EXPERIMENTAL
  5. description
    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.
    intervention Names
    1. Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
    label
    EBV+ NPC (Tab-cel Only)
    type
    EXPERIMENTAL
  6. description
    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.
    intervention Names
    1. Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
    label
    EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
    type
    EXPERIMENTAL
  7. description
    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.
    intervention Names
    1. Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
    label
    EBV+ PTLD-SOT R/R Rituximab + Chemo (EBV-CTLs Only)
    type
    EXPERIMENTAL
  8. description
    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.
    intervention Names
    1. Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
    label
    EBV+ Viremia (EBV-CTLs Only)
    type
    EXPERIMENTAL
  9. description
    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.
    intervention Names
    1. Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
    label
    EBV+ PID-LPD (Tab-cel or EBV-CTLs)
    type
    EXPERIMENTAL
  10. description
    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.
    intervention Names
    1. Biological: Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
    label
    EBV+ Lymphoma (Tab-cel or EBV-CTLs)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. EBV+ AID-LPD (Tab-cel Only)
    2. EBV+ LMS (Tab-cel Only)
    3. EBV+ Lymphoma (Tab-cel or EBV-CTLs)
    4. EBV+ NPC (Tab-cel Only)
    5. EBV+ PID-LPD (Tab-cel or EBV-CTLs)
    6. EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
    7. EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
    8. EBV+ PTLD-SOT R/R Rituximab + Chemo (EBV-CTLs Only)
    9. EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only)
    10. EBV+ Viremia (EBV-CTLs Only)
    description
    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.
    name
    Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
    other Names
    1. tabelecleucel (tab-cel®, ATA129), allogeneic EBV-CTLs
    2. transplant donor-derived EBV-CTLs
    type
    BIOLOGICAL
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
58
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Objective Response Rate (ORR)
    time Frame
    From Day 1 through 251.1 months after Day 1 dose
secondary Outcomes
  1. description
    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.
    measure
    Overall Survival (OS)
    time Frame
    From Day 1 through 251.1 months after Day 1 dose
  2. description
    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.
    measure
    OS Rate at 12 Months
    time Frame
    From Day 1 through 12 months after Day 1 dose
  3. description
    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.
    measure
    OS Follow-up Time
    time Frame
    From Day 1 through 251.1 months after Day 1 dose
  4. description
    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.
    measure
    Time to Response (TTR)
    time Frame
    From Day 1 through 251.1 months after Day 1 dose
  5. description
    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.
    measure
    Clinical Benefit Rate (CBR)
    time Frame
    From Day 1 through 251.1 months after Day 1 dose
Full study description
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.
Source references
references
  1. citation
    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.
    pmid
    31689242
    type
    DERIVED
Source notices and limitations
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    Preserved source evidence · Not medical advice