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The purpose of this study is to see how well transfusions of T-cells work in treating CMV. Tcells are a type of white blood cell that helps protect the body from infection. A transfusion is the process by which blood from one person is transferred to the blood of another. In this case, the T-cells are made from the blood of donors who are immune to CMV. The T-cells are then grown and taught to attack the CMV virus in a lab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMVpp65-CTL T-cells | Experimental | The T-cells to be infused will be selected from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 10^6 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMVpp65 Specific T-cells | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response | defined as the clearance of the CMV infection 3-7 weeks following completion of the last cycle of CMV CTLs. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With SAE's Possibly Related to Study Treatment | Will be capturing and tracking Grade 3-5 toxicities which occur within 30 days following an infusion of CMVpp65-specific. For the evaluation of toxicities, the NCI Standard Toxicity Scale 4.0 will be employed. | 2 years |
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Inclusion Criteria:
Each patient must satisfy at least one of the following criteria:
Patient must also satisfy at least one of the following criteria:
The patient's CMV infection is clinically progressing or CMV viremia is persistent or increasing (as evidenced by quantitation of CMV DNA in the blood) despite two weeks induction therapy with antiviral drugs.
Or
The patient has developed CMV viremia as attested by viral culture, or detection of levels of CMV DNA in blood or body fluids while receiving prophylactic doses of antiviral drugs to prevent CMV infection post transplant.
Or
The patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC< 1000μl/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance ≤ 60 ml/min/1.73 m^2 or serum creatinine > 2 mg/dl]) CMV infections are life threatening, and may involve multiple organ systems such as the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems. Antiviral drugs used for treatment may also compromise renal and hematopoietic function. Therefore, dysfunctions of these organs will not affect eligibility for this protocol.
Patients must meet the following clinical criteria to receive CMVpp65-CTL infusions
Patient must also satisfy at least one of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Prockop, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | CMVpp65-CTL T-cells | The T-cells to be infused will be selected from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 10^6 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement. CMVpp65 Specific T-cells |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2021 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CMVpp65-CTL T-cells | The T-cells to be infused will be selected from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 10^6 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement. CMVpp65 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, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | Complete Response | defined as the clearance of the CMV infection 3-7 weeks following completion of the last cycle of CMV CTLs. | Posted | Count of Participants | Participants | 2 years |
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| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With SAE's Possibly Related to Study Treatment | Will be capturing and tracking Grade 3-5 toxicities which occur within 30 days following an infusion of CMVpp65-specific. For the evaluation of toxicities, the NCI Standard Toxicity Scale 4.0 will be employed. | Posted | Count of Participants | Participants | 2 years |
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2 years
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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 | CMVpp65-CTL T-cells | The T-cells to be infused will be selected from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 10^6 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement. CMVpp65 Specific T-cells | 16 | 77 | 22 | 77 | 9 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| Autoimmune disorder | Immune system disorders | Systematic Assessment |
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| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Systematic Assessment |
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| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Catheter related infection | Infections and infestations | Systematic Assessment |
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| Confusion | Psychiatric disorders | Systematic Assessment |
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| Death NOS | General disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Ejection fraction decreased | Investigations | Systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Heart failure | Cardiac disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Iron overload | Metabolism and nutrition disorders | Systematic Assessment |
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| Lung infection | Infections and infestations | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | Systematic Assessment |
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| Multi-organ failure | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Resp, thoracic & mediastinal disorder Other, spec | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Retinal detachment | Eye disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders - Other, spec | Blood and lymphatic system disorders | Systematic Assessment |
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| Encephalitis infection | Infections and infestations | Systematic Assessment |
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| Heart failure | Cardiac disorders | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
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| Lung infection | Infections and infestations | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin Curran, MD | Memorial Sloan Kettering Cancer Center | 212-639-5836 | currank@mskcc.org |
| Sep 23, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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