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Insufficient recruitment rate
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To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| baltaleucel-T | Experimental | Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| baltaleucel-T | Biological | Autologous EBV-specific T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response | Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events will be recorded from the time of the first investigational cell product dose is administered until 30 days after the last administration. Serious events recorded for up to 1 year after administration. | 1 year |
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Inclusion Criteria:
The study will include three primary cohorts, with any of the following EBV+ diseases:
Cohort A - DLBCL, 1) in first or subsequent relapse, not eligible for autologous transplantation following salvage therapy OR 2) relapse following autologous transplantation.
Cohort B - HL, brentuximab vedotin (BV) treatment failure or unable to tolerate BV.
Cohort C - PTLD, rituximab treatment failure.
Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months.
Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory.
Absolute lymphocyte count (ALC) >500/µL
Male or female ≥ 12 years of age
Weight ≥ 35 kg
Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or Lansky score ≥ 60, as age appropriate
Able to understand and comply with the requirements of the study and to provide written informed consent or age appropriate assent for pediatric patients.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Gunter, MD | Cell Medica, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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Study was closed early due to inadequate recruitment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baltaleucel-T | Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. baltaleucel-T: Autologous EBV-specific T cells |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baltaleucel-T | Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. baltaleucel-T: Autologous EBV-specific T cells |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Best Overall Response | Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up. | Subject was withdrawn early before first disease assessment timepoint. | Posted | 1 year |
|
|
1 month
Prescheduled hospital admissions, hospital admissions for elective surgery, transfusions, diagnostic procedures are not considered to be SAEs. Events related to progression of the underlying malignancy will likewise not be categorized as serious.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baltaleucel-T | Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. baltaleucel-T: Autologous EBV-specific T cells |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytokine Release Syndrome | Immune system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment | Grade 1 |
Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kurt Gunter (Chief Medical Officer) | Cell Medica | 832-581-4480 | Kurt.Gunter@cellmedica.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2017 | Feb 19, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020031 | Epstein-Barr Virus Infections |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cohort B - Hodgkin Lymphoma (HL) | Relapse or refractory HL disease post brentuximab vedotin (BV) or unable to tolerate BV. | Count of Participants | Participants |
|
| Secondary | Adverse Events | Adverse events will be recorded from the time of the first investigational cell product dose is administered until 30 days after the last administration. Serious events recorded for up to 1 year after administration. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 1 |
| 1 |
| 1 |
| 1 |
| 1 |
| 1 |
| Hemophagocytic Lymphohistiosytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment | Grade 3 |
|
| Platelet Count Decreased | Investigations | Systematic Assessment | Grade 4 |
|
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |