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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00929 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-0350 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase I trial studies the side effects of allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) and to see how well they work in treating patients with a weakened immune system (immunocompromised) and adenovirus-related disease. Allogeneic adenovirus-specific cytotoxic T lymphocytes are made from donated blood cells grown in the laboratory and are designed to kill viruses that can cause infections in immunocompromised patients with adenovirus-related disease.
PRIMARY OBJECTIVES:
I. To assess the feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of asymptomatic adenovirus viremia or adenovirus-related disease in immunocompromised hosts.
SECONDARY OBJECTIVES:
I. To obtain preliminary data about the efficacy of administering most closely HLA-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of adenovirus viremia or adenovirus-related disease.
II. To assess the persistence of the administered cells in the patients.
OUTLINE:
Within two weeks of enrollment, patients receive allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) intravenously (IV) over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (allogeneic adenovirus-specific CTLs) | Experimental | Within two weeks of enrollment, patients receive allogeneic adenovirus-specific CTLs IV over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes | Biological | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 | Safety and tolerability will be assessed by laboratory assessments, adverse events, and serious adverse events. Adverse events will be graded by the CTCAE version 4.0. Categorical measures will be summarized using frequencies and percentages while continuous variables will be summarized using means, standard deviations, medians, minimums, and maximums. | Up to 1 year |
| Assessment of response to allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) | The proportion of patients experiencing response will be computed with associated 95% confidence interval (CI). The 95% exact CI for the feasibility criterion of 50% will extend from 25% to 75% for 16 patients. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS will be defined from treatment start date to date of death. Patients who are still alive at end of study will be censored. OS will be estimated using the Kaplan-Meier method. | From the start of study treatment up to 1 year |
| Relapse-free survival (RFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Marin, MD | Contact | 713-792-8750 | dmarin@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| David Marin | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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RFS (original malignancy) will be defined from treatment start date to the date of documented disease recurrence or death. Patients who are still alive without disease progression at end of study will be censored. RFS will be estimated using the Kaplan-Meier method. |
| From the start of study treatment up to 1 year |
| Cumulative incidence of adenovirus reactivation after therapy | Cumulative incidence of adenovirus reactivation after therapy will be assessed using the competing risks method. The competing risks will include relapse and death and patients who are still alive without disease progression at end of study will be censored. | Up to 1 year |
| Cumulative incidence of graft versus host disease (GVHD) | Cumulative incidence of grade 2-4 GVHD, grade 3-4 GVHD, and chronic GVHD will be assessed using the competing risks method. The competing risks will include relapse and death and patients who are still alive without disease progression at end of study will be censored. | Up to 1 year |
| Reconstitution of anti-adenovirus immunity | The number of adenovirus specific T-cells in blood will be determined for each patient. The proportion of patients with population of cells that are specific and can be detected will be computed along with associated 95% CI. | Up to 1 year |