Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is for patients with chronic granulomatous disease (CGD), which is a disorder of the immune system that puts them at risk for severe infections. CGD is caused by a genetic defect that stops or prevents the white blood cells from killing certain bacteria and fungi. This condition cannot presently be cured by standard treatment with drugs or surgery. Medicine including antibiotics, antifungals, and interferon gamma, may help some patients with CGD; however even with continuous treatment, most patients with CGD will have chronic and recurrent infections. Transfusion of white blood cells may help overcome infection, but white cell transfusions lead to allergic reactions and fever and the benefit of transfusion lasts only a matter of hours. Ultimately, chronic infections can damage or injure the body organs. Injury to the lung or liver can lead to lung or liver failure and death. Medicines used to treat infection can damage body organs too. Infections may become resistant to antibiotic or antifungal treatment, and infections not responding to treatment can be deadly.
It is now known that under specific conditions and with special treatment, blood stem cells (the cells that make blood) can be transplanted from one person to another. Stem cell transplantation has been done for patients with CGD who have a healthy sibling and who share the same immune type (HLA type) as the patient. Stem cell transplantation allows healthy or normal white cells from the stem cell donor to grow or develop in the patient's bone marrow. These healthy white cells can fight infection and prevent future infections for a patient with CGD.
Patients on this study will receive stem cells from a related or unrelated donor. The donor will be closely matched to the patient's immune type but the donor is not a sibling. The reason this treatment is investigational is that we do not know the likelihood of benefit that the patient will receive. It is possible that they will have great benefit, like some of the patients who have been transplanted from a brother or sister. It is possible that the side-effects of treatment may be too severe so that the transplant won't work.
The purpose of this research study is to evaluate whether or not patients with CGD treated with a stem cell transplant from a non-matched and/or non-related donor can have a good outcome from the procedure with an acceptable number of side-effects.
In order to transplant stem cells we will need to give the patient drugs or high-dose chemotherapy to kill or destroy most of the blood forming and immune cells in the bone marrow. This is necessary to allow the donor stem cells to live and grow (engraft) in the bone marrow space. After the drug treatment is completed, the patient will be given the stem cells from the donor. The drug treatment is as follows:
Day -9 Busulfan
Day -8 Busulfan
Day -7 Busulfan
Day -6 Busulfan
Day -5 Alemtuzumab, Fludarabine, Cyclophosphamide
Day -4 Alemtuzumab, Fludarabine, Cyclophosphamide
Day -3 Alemtuzumab, Fludarabine, Cyclophosphamide
Day -2 Alemtuzumab, Fludarabine, Cyclosporine, Cyclophosphamide
Day -1 REST
Day 0 Stem cell infusion
The day after the chemotherapy treatment is completed, the patient will receive the healthy stem cells by vein, like a blood transfusion. Once in the bloodstream, the marrow cells will go to the bone marrow and grow.
It is also possible that if the marrow takes, it will cause a disease known as graft-versus-host disease (GVHD). To prevent GVHD, we will give the patient cyclosporine and Methotrexate. Methotrexate will be administered on Days 1, 3, 6 and 11 after the transplant. The cyclosporine therapy will continue for a longer period of time, however if the patient does not develop GVHD, it will be discontinued by 6 months after the stem cell transplant.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic unrelated transplant | Experimental | Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Busulfan | Drug | Days -9 through -6 1 mg/kg initially (based on weight) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Engraftment | To estimate the engraftment rate for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors. | 28 days post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients That Have Complete Donor Chimerism After Transplant. | To estimate the likelihood of complete donor chimerism for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors. | 120 days post transplant |
Not provided
INCLUSION CRITERIA:
CGD patients as documented by an abnormal NBT assay in a male patient and/or abnormal NADPH enzyme mutation confirmed by genetic analysis with abnormal NBT.
Patients must not have an HLA genotype identical donor.
Patients must have a 5/6 or 6/6 HLA-matched unrelated donor or a 5/6 or 6/6 HLA phenotype-matched related donor.
Patients must have had at least one serious infection characteristic of those manifested in patients with CGD.
Patients must not have active infection. An active infection may include the following: 1) clinical findings consistent with an infection such as fever, cavitary organ lesions, osteomyelitis; 2) progression of presumed infection based upon findings of diagnostic imaging (two or more studies at least 1 month a part).
No cumulative organ dysfunction that, in the estimation of the treating physicians, will diminish the patient's likelihood to survive this procedure.
Negative pregnancy test for post-pubertal female patients.
Echocardiogram shortening fraction >/= 28%.
DLCO 50% or greater predicted or FEV1 >/= 50% predicted.
EXCLUSION CRITERIA:
Active or uncontrolled infection (e.g. lung infection, cavitary organ lesions, osteomyelitis).
Markedly elevated C reactive protein or sedimentation rate relative to patient's baseline.
Invasive bone or bone marrow disease.
Lack of potential hematologic blood product donors in the past (related to McLeod phenotype).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Krance, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Allogeneic Unrelated Transplant | Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion. Busulfan: Days -9 through -6 1 mg/kg initially (based on weight) Alemtuzumab: Day -5 through Day -2 Dose is based on weight: Less than 15 kg: 3 mg More than 15 kg to 30 kg: 5 mg More than 30 kg: 15 mg Cyclophosphamide: Days -5 through -2 50 mg/kg Fludarabine: Day -5 through Day -2 30 mg/m^2 Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours. Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Mar 13, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Alemtuzumab | Biological | Day -5 through Day -2 Dose is based on weight: Less than 15 kg: 3 mg More than 15 kg to 30 kg: 5 mg More than 30 kg: 15 mg |
|
|
| Cyclophosphamide | Drug | Days -5 through -2 50 mg/kg |
|
|
| Fludarabine | Drug | Day -5 through Day -2 30 mg/m^2 |
|
|
| Cyclosporine | Drug | Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours. |
|
|
| Stem Cell Infusion | Procedure | Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells. |
|
| Number of Patients That Have Acute GVHD and Regimen Related Morbidity/Mortality Post Transplant. | To estimate the risk for acute GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors. | Assessed between day 0 and day 100 post transplant |
| Number of Patients That Have Chronic GVHD and Regimen Related Morbidity/Mortality Post Transplant. | To estimate the risk for chronic GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors. | Assessed between day 100 and day 365 post transplant |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis included 15 patients who underwent HLA matched unrelated or non-genotype identical related donor transplantation for chronic granulomatous disease(CGD).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Allogeneic Unrelated Transplant | Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion. Busulfan: Days -9 through -6 1 mg/kg initially (based on weight) Alemtuzumab: Day -5 through Day -2 Dose is based on weight: Less than 15 kg: 3 mg More than 15 kg to 30 kg: 5 mg More than 30 kg: 15 mg Cyclophosphamide: Days -5 through -2 50 mg/kg Fludarabine: Day -5 through Day -2 30 mg/m^2 Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours. Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ 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 | 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 | Percentage of Participants With Engraftment | To estimate the engraftment rate for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors. | Posted | Number | percentage of participants | 28 days post transplant |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Patients That Have Complete Donor Chimerism After Transplant. | To estimate the likelihood of complete donor chimerism for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors. | One patient died on day 62 post transplant and was not included in the analysis. | Posted | Number | participants | 120 days post transplant |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Patients That Have Acute GVHD and Regimen Related Morbidity/Mortality Post Transplant. | To estimate the risk for acute GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors. | One patient who died on day 62 post transplant without developing acute GVHD was not assessed for this Outcome Measure. | Posted | Count of Participants | Participants | Assessed between day 0 and day 100 post transplant |
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients That Have Chronic GVHD and Regimen Related Morbidity/Mortality Post Transplant. | To estimate the risk for chronic GVHD and regimen related morbidity/mortality for patients with CGD following stem cell transplant from 5/6 or 6/6 HLA matched unrelated or 5/6 or 6/6 HLA phenotype matched related donors. | One patient died on day 62 post transplant, and one patient was lost to F/U on day 163 post transplant. They were not assessed for this Outcome Measure. | Posted | Count of Participants | Participants | Assessed between day 100 and day 365 post transplant |
|
Adverse events excluding fevers and hematological toxicities were collected up to 30 days after transplant. SAEs excluding fevers and hematological toxicities were collected up to 100 days after transplant.
An adverse event was defined as grade III or grade IV toxicity by the NCI Common Toxicity Criteria Version 3.0. A SAE is any adverse event that was fatal, life threatening , required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product(s) or considered a significant medical event by the investigator.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Allogeneic Unrelated Transplant | Conditioning from Day -9 to Day -1. Stem cells given on Day 0. Busulfan, alemtuzumab, cyclophosphamide, fludarabine, cyclosporine, stem cell infusion. Busulfan: Days -9 through -6 1 mg/kg initially (based on weight) Alemtuzumab: Day -5 through Day -2 Dose is based on weight: Less than 15 kg: 3 mg More than 15 kg to 30 kg: 5 mg More than 30 kg: 15 mg Cyclophosphamide: Days -5 through -2 50 mg/kg Fludarabine: Day -5 through Day -2 30 mg/m^2 Cyclosporine: Cyclosporine will be administered beginning Day -2. Initial dose will 5 mg/kg infused over 24 hours. Stem Cell Infusion: Stem Cell: Either bone marrow, cord blood, or peripheral blood stem cells may be used for stem cell transplantation. It is desired to infuse: for bone marrow, nucleated cells ≥ 4 X 10^8/kg recipient weight; for cord blood ≥ 3 X 10^7/kg nucleated cells; for peripheral blood stem cells ≥ 1 X 10^/kg CD34+ cells. | 1 | 15 | 9 | 15 | 14 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constitutional Symptoms - Other: Multiorgan failure | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea patients without colostomy | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastrointestinal-Other: Eosinofilic enteritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematuria (in the absence of vaginal bleeding) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Other: Adenovirus viremia, BK viruria, CMV viremia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Other: Hemorrhagic cystitis with BK virus, adenovirus, and CMV | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: Respiratory distress | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea patients without colostomy | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematuria (in the absence of vaginal bleeding) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| GGT (Gamma-Glutamyl transpeptidase) | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| SGPT (ALT) (serum glutamic pyruvic transaminase) | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Catheter-related infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia(ANC<1.0x10e9/L) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Amylase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GGT (gamma-Glutamyl transpeptidase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Seizure(s) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Krance, MD | Baylor College of Medicine | (832) 824-4661 | rakrance@txch.org |
| Jul 16, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006105 | Granulomatous Disease, Chronic |
| ID | Term |
|---|---|
| D010585 | Phagocyte Bactericidal Dysfunction |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002066 | Busulfan |
| D000074323 | Alemtuzumab |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
Not provided
Not provided
| Asian |
|
| Hispanic or Latino |
|
| Unknown |
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|