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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
| The Methodist Hospital Research Institute | OTHER |
| Center for Cell and Gene Therapy, Baylor College of Medicine | OTHER |
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The subjects eligible for this trial have a type of blood cell cancer, other blood disease or a genetic disease for which they will receive a stem cell transplant. The donor of the stem cells will be either the subject's brother or sister, or another relative, or a closely matched unrelated donor. The Investigators are asking subjects to participate in this study which tests if blood cells from the subject's donor that have been grown in a special way, can prevent or be a effective treatment for early infection by five viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV), adenovirus, BK virus (BKV) and human herpes virus 6 (HHV6).
The Investigators have grown T cells from the subject's stem cell donor in the laboratory in a way that will train them to recognize the viruses and control them when the T cells are given after a transplant. This treatment with specially trained T cells (also called cytotoxic T cells or "CTLs") has had activity against three of these viruses (CMV, EBV and Adenovirus) in previous studies. In this study the Investigators want to see if they increase the number of viruses that can be targeted to include BKV and HHV6 using a simple and fast approach to make the cells.
The Investigators want to see if they can use a kind of white blood cell called T lymphocytes (or T cells) to prevent and treat adenovirus, CMV, EBV, BKV and HHV6 in the early stages of reactivation or infection.
To make the CTLs, subject's donors' cells were mixed with small pieces of proteins, called peptides that come from adenovirus, CMV, EBV, BKV and HHV6. These peptides stimulate donor T cells that react against the viruses to grow and train the donor T cells to kill cells that are infected with CMV, EBV, adenovirus, BKV and HHV6. Once sufficient numbers of T cells were made, they were tested to make sure they would target the cells infected with these viruses but not the normal cells. Then the cells were frozen.
When the Investigators think the subject needs them, the subject's donor's CTL cells will be thawed and injected into the intravenous line. To prevent an allergic reaction, prior to receiving the CTLs the subject may be given diphenhydramine (Benadryl) and acetaminophen (Tylenol). After the subject receives the cells, Investigators will monitor the levels of these five viruses in the blood. They will also take blood to see how long the T cells they gave the subject are lasting in the body.
If the CTL infusion has helped the subjects infection or if they have had a treatment, for example with steroid drugs that might have destroyed the T cells the subject was given, then they are allowed to receive up to 2 more doses of the cells.
The first part of this study was a dose escalation study. That means that at the beginning, patients were started on the lowest dose (1 of 3 different levels) of T cells. The next group of patients were started at a higher dose. This process continued until all 3 dose levels were studied. They would now like to enroll more patients at the highest dose level to get more information about how the T cells work.
Subjects will continue to be followed by their transplant doctors after the injection. The subject will either be seen in the clinic or they will be contacted by a research nurse to follow up for this study every week for 6 weeks then at 8 week and 3, 6 and 12 months. The subject may have other visits for their standard care. Subjects will also have regular blood tests done to follow their counts and the viral infection. To learn more about the way the T cells are working in the body, up to an extra 30-40 ml (6-8 teaspoons) of blood will be taken before the infusion and then at 1, 2, 4, 5, 6 and 8 weeks and 3 months. Blood should come from the central intravenous line, and should not require extra needle sticks.
If subjects experience a positive response or are taking medicines (such as steroids) that may affect how long T cells stay in the body, they may be able to receive up to two additional doses of the T cells at the same initial dose level from 28 days after their initial dose. After each T-cell infusion, they will be monitored as described above.
Study Duration: Subjects will be on study for approximately one year. If they receive additional doses of the T cells as described above, they will be followed until 1 year after their last dose of T-cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multivirus-specific T cells 5*10^6 mCTLs/m2 for Prophylaxis | Experimental | Cohort 1 prophylaxis: Participants were administrated 5*10^6 mCTLs/m multivirusspecific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
|
| Multivirus-specific T cells 5*10^6 mCTLs/m2 for Treatment | Experimental | Cohort 1 treatment: Participants were administrated 5*10^6 mCTLs/m multivirusspecific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
|
| Multivirus-specific T cells 1*10^7 mCTLs/m2 for Prophylaxis | Experimental | Cohort 2 prophylaxis: Participants were administrated 1*10^7 mCTLs/m multivirusspecific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
|
| Multivirus-specific T cells 1*10^7 mCTLs/m2 for Treatment | Experimental | Cohort 2 treatment: Participants were administrated 1*10^7 mCTLs/m multivirusspecific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivirus-specific T cells Dose Level 1 | Biological | The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level. Dose Level One: 5x10^6 mCTLs/m2 There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a DLT | DLT is defined as acute GvHD grades III-IV within 42 days of the last dose of CTLs, # of patients with Grade 3-5 infusion-related adverse events within 30 days of the last dose of CTLs, and # of patients with Grade 4-5 non-hematological adverse events within 30 days of the last dose of CTLs. GVHD grade III-IV scoring is based on the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) GVHD scoring stamp or equivalent. Grade 3-5 infusion-related adverse events and Grade 4-5 non-hematological adverse events are graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.X. | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Have a Response in Anti-viral Activity | Percentage of patients who have a response in anti-viral activity that is defined as a viral load reduction to the normal level for at least one of the five virus types | 42 days |
| Percentage Change of Viral Load From Baseline to Follow-up |
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Inclusion Criteria:
Patients will be eligible following any type of allogeneic transplant to receive CTLs as prevention or for early reactivations as defined below.
Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells within 12 months.
Prevention for patients at risk of CMV, adenovirus, EBV, BK virus, or HHV6 infection
Treatment of reactivation or infection which is defined for each virus as below
Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture from more than two sites such as stool or blood or urine or nasopharynx.
In patients who meet the criteria for disease Cidofovir may be added unless the subject could not tolerate this agent due to nephrotoxicity. Patients may receive CTLs for elevated PCR in blood or stool.
Treatment may be given to eligible patients with a single or multiple infections. Patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll.
Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone.
Karnofsky/Lansky score of ≥ 50
ANC greater than 500/µL.
Bilirubin </= 2x upper limit normal
AST </= 3 x upper limit normal
Serum creatinine </= 2 x upper limit normal
HgB > 8.0
Pulse oximetry of > 90% on room air
Available multivirus-specific CTLs
Negative pregnancy test in female patients if applicable (childbearing potential who have received a reduced intensity conditioning regimen).
Written informed consent and/or signed assent line from patient, parent or guardian.
Exclusion Criteria:
Patients receiving ATG, or Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment.
Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.
Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
Patients who have received donor lymphocyte infusion (DLI) within 28 days.
Patients with active acute GVHD grades II-IV.
Active and uncontrolled relapse of malignancy
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| Name | Affiliation | Role |
|---|---|---|
| Helen Heslop, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States | ||
| Texas Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24964991 | Derived | Papadopoulou A, Gerdemann U, Katari UL, Tzannou I, Liu H, Martinez C, Leung K, Carrum G, Gee AP, Vera JF, Krance RA, Brenner MK, Rooney CM, Heslop HE, Leen AM. Activity of broad-spectrum T cells as treatment for AdV, EBV, CMV, BKV, and HHV6 infections after HSCT. Sci Transl Med. 2014 Jun 25;6(242):242ra83. doi: 10.1126/scitranslmed.3008825. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multivirus-specific T Cells 5*10^6 mCTLs/m2 for Prophylaxis | Cohort 1 prophylaxis: Participants were administrated 5*10^6 mCTLs/m multivirus-specific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cohort 1: Dose Level 1 |
|
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| Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Prophylaxis | Experimental | Cohort 3 prophylaxis: Participants were administrated 2*10^7 mCTLs/m multivirusspecific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
|
| Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Treatment | Experimental | Cohort 3 treatment: Participants were administrated 2*10^7 mCTLs/m multivirusspecific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
|
|
| Multivirus-specific T cells Dose Level 2 | Biological | The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level. Dose Level Two: 1x10^7 mCTLs/m2 There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL |
|
| Multivirus-specific T cells Dose Level 3 | Biological | The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level. Dose Level Three: 2x10^7 mCTLs/m2 There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL |
|
Percentage change of viral load by PCR from baseline to follow-up. A positive number indicates a percentage decrease and a negative number indicates a percentage increase. |
| 3 months |
| Median Peak Frequency of Specific T Cells Post-infusion | Median peak frequency of specific T cells as measured by Elispot to assess reconstitution of antiviral immunity. | 3 months |
| Houston |
| Texas |
| 77030 |
| United States |
| Multivirus-specific T Cells 5*10^6 mCTLs/m2 for Treatment |
Cohort 1 treatment: Participants were administrated 5*10^6 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| FG002 | Multivirus-specific T Cells 1*10^7 mCTLs/m2 for Prophylaxis | Cohort 2 prophylaxis: Participants were administrated 1*10^7 mCTLs/m multivirus-specific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| FG003 | Multivirus-specific T Cells 1*10^7 mCTLs/m2 for Treatment | Cohort 2 treatment: Participants were administrated 1*10^7 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| FG004 | Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Prophylaxis | Cohort 3 prophylaxis: Participants were administrated 2*10^7 mCTLs/m multivirus-specific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| FG005 | Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Treatment | Cohort 3 treatment: Participants were administrated 2*10^7 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Cohort 2: Dose Level 2 |
|
|
| Cohort 3: Dose Level 3 |
|
|
Eligible patients who received multivirus-specific T cells per protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Multivirus-specific T Cells 5*10^6 mCTLs/m2 | Cohort 1 (prophylaxis and treatment): Participants were administrated 5*10^6 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| BG001 | Multivirus-specific T Cells 1*10^7 mCTLs/m2 | Cohort 2 (prophylaxis and treatment): Participants were administrated 1*10^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| BG002 | Multivirus-specific T Cells 2*10^7 mCTLs/m2 | Cohort 3 (prophylaxis and treatment): Participants were administrated 2*10^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | Number of Participants With a DLT | DLT is defined as acute GvHD grades III-IV within 42 days of the last dose of CTLs, # of patients with Grade 3-5 infusion-related adverse events within 30 days of the last dose of CTLs, and # of patients with Grade 4-5 non-hematological adverse events within 30 days of the last dose of CTLs. GVHD grade III-IV scoring is based on the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) GVHD scoring stamp or equivalent. Grade 3-5 infusion-related adverse events and Grade 4-5 non-hematological adverse events are graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.X. | Data is reported for all participants who received multivirus-specific T cells. A participant is not evaluable for DLT if the participant was removed from the study before 42 days follow up due to a reason other than DLT. | Posted | Count of Participants | Participants | 42 days |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Have a Response in Anti-viral Activity | Percentage of patients who have a response in anti-viral activity that is defined as a viral load reduction to the normal level for at least one of the five virus types | Data is reported for all participants who received multivirus-specific CTLs for treatment of EBV, CMV, adenovirus, HHV6 and BK virus. | Posted | Number | 95% Confidence Interval | percentage of participants | 42 days |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change of Viral Load From Baseline to Follow-up | Percentage change of viral load by PCR from baseline to follow-up. A positive number indicates a percentage decrease and a negative number indicates a percentage increase. | Data is reported for all participants who received multivirus-specific CTLs for treatment of EBV, CMV, adenovirus, HHV6 and BK virus. | Posted | Median | Full Range | percentage change | 3 months |
| |||||||||||||||||||||||||||||||||||
| Secondary | Median Peak Frequency of Specific T Cells Post-infusion | Median peak frequency of specific T cells as measured by Elispot to assess reconstitution of antiviral immunity. | Data is reported for all participants who received multivirus-specific CTLs for treatment of EBV, CMV, adenovirus, HHV6 and BK virus. | Posted | Median | Full Range | spot forming cells/5 * 10^5 input cells | 3 months |
|
Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
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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 | Multivirus-specific T Cells 5*10^6 mCTLs/m2 | Cohort 1 (prophylaxis and treatment): Participants were administrated 5*10^6 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. | 0 | 4 | 4 | 4 | ||
| EG001 | Multivirus-specific T Cells 1*10^7 mCTLs/m2 | Cohort 2 (prophylaxis and treatment): Participants were administrated 1*10^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. | 1 | 4 | 4 | 4 | ||
| EG002 | Multivirus-specific T Cells 2*10^7 mCTLs/m2 | Cohort 3 (prophylaxis and treatment): Participants were administrated 2*10^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant. | 4 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Chills | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| Fever | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| Infections and infestations - Other, specify: RSV | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Infections and infestations - Other, specify: rhinovirus | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Urethral infection | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | CTCAE V4.X | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE V4.X | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE V4.X | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify: dysuria | Renal and urinary disorders | CTCAE V4.X | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE V4.X | Systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE V4.X | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | CTCAE V4.X | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify: Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify: lung inflitrates | Respiratory, thoracic and mediastinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE V4.X | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE V4.X | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE V4.X | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | CTCAE V4.X | Systematic Assessment |
| |
| Eye pain | Eye disorders | CTCAE V4.X | Systematic Assessment |
| |
| Photophobia | Eye disorders | CTCAE V4.X | Systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE V4.X | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify: Intercurrent gastroenteritis | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE V4.X | Systematic Assessment |
| |
| Chills | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| Fever | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: PICC line pain | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: flank pain | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: pain- knees | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: pain- legs | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| Irritability | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| Localized edema | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| Pain | General disorders | CTCAE V4.X | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE V4.X | Systematic Assessment |
| |
| Eye infection | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Infections and infestations - Other, specify: Rhinovirus | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Infections and infestations - Other, specify: clostridium difficile | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Infections and infestations - Other, specify: human herpes virus 7 | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Infections and infestations - Other, specify: oral thrush | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Infections and infestations - Other, specify: oropharyngeal candidiasis | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Infections and infestations - Other, specify: rhinovirus | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Otitis media | Infections and infestations | CTCAE V4.X | Systematic Assessment |
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| Sinusitis | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE V4.X | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE V4.X | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE V4.X | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE V4.X | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE V4.X | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE V4.X | Systematic Assessment |
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| Hemoglobin increased | Investigations | CTCAE V4.X | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE V4.X | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE V4.X | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE V4.X | Systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE V4.X | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE V4.X | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE V4.X | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE V4.X | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE V4.X | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE V4.X | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE V4.X | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE V4.X | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE V4.X | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | CTCAE V4.X | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE V4.X | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE V4.X | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE V4.X | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE V4.X | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE V4.X | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE V4.X | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE V4.X | Systematic Assessment |
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| Hypersomnia | Nervous system disorders | CTCAE V4.X | Systematic Assessment |
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| Nervous system disorders - Other, specify: delayed speech | Nervous system disorders | CTCAE V4.X | Systematic Assessment |
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| Nervous system disorders - Other, specify: right hand weakness | Nervous system disorders | CTCAE V4.X | Systematic Assessment |
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| Nystagmus | Nervous system disorders | CTCAE V4.X | Systematic Assessment |
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| Tremor | Nervous system disorders | CTCAE V4.X | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE V4.X | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE V4.X | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | CTCAE V4.X | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | CTCAE V4.X | Systematic Assessment |
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| Renal and urinary disorders - Other, specify: dysuria | Renal and urinary disorders | CTCAE V4.X | Systematic Assessment |
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| Urine discoloration | Renal and urinary disorders | CTCAE V4.X | Systematic Assessment |
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| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE V4.X | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE V4.X | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE V4.X | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE V4.X | Systematic Assessment |
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| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE V4.X | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE V4.X | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders - Other, specify: rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE V4.X | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE V4.X | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE V4.X | Systematic Assessment |
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| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE V4.X | Systematic Assessment |
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| Pain of skin | Skin and subcutaneous tissue disorders | CTCAE V4.X | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE V4.X | Systematic Assessment |
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| Purpura | Skin and subcutaneous tissue disorders | CTCAE V4.X | Systematic Assessment |
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| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE V4.X | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE V4.X | Systematic Assessment |
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| Skin and subcutaneous tissue disorders - Other, specify: diaper rash | Skin and subcutaneous tissue disorders | CTCAE V4.X | Systematic Assessment |
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| Skin and subcutaneous tissue disorders - Other, specify: lacy rash | Skin and subcutaneous tissue disorders | CTCAE V4.X | Systematic Assessment |
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| Skin and subcutaneous tissue disorders - Other, specify: rosacea | Skin and subcutaneous tissue disorders | CTCAE V4.X | Systematic Assessment |
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| Skin and subcutaneous tissue disorders - Other, specify: skin irritation | Skin and subcutaneous tissue disorders | CTCAE V4.X | Systematic Assessment |
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| Skin and subcutaneous tissue disorders - Other, specify: umbilical wound | Skin and subcutaneous tissue disorders | CTCAE V4.X | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE V4.X | Systematic Assessment |
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| Flushing | Vascular disorders | CTCAE V4.X | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE V4.X | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Helen Heslop | Center for Cell and Gene Therapy | 832-824-4662 | heheslop@txch.org |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D000257 | Adenoviridae Infections |
| D020031 | Epstein-Barr Virus Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D006566 | Herpesviridae Infections |
| D014412 | Tumor Virus Infections |
Not provided
Not provided
| Received other hematopoietic cells |
|
| Received other hematopoietic cells |
|
| Male |
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| African American |
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| Hispanic or Latino |
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| Asian |
|
| Not evaluable |
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