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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00609 | Registry Identifier | NCI Clinical Trial Registration Program |
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| Name | Class |
|---|---|
| Assisi Foundation | OTHER |
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In this study, participants with high-risk hematologic malignancies undergoing hematopoietic cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA) matched related/sibling donor (MSD) or matched unrelated donor (MUD) identified, will receive a haploidentical donor HCT with additional natural killer (NK) cells.
The investigators anticipate enrollment of 75 donors and 75 recipients.
PRIMARY OBJECTIVE:
SECONDARY OBJECTIVES:
Donors will undergo G-CSF mobilization of peripheral blood stem cells (PBSC) prior to undergoing two apheresis collections of hematopoietic progenitor cells (HPC,A) and one apheresis collection of therapeutic cell product of purified natural killer cells (TC-NK).
The HPC products will be T-cell depleted (TCD) using the investigational CliniMACS device. CD34+ enrichment and CD45RA depletion will be utilized on sequential HPC grafts.
Participants will undergo a preparative regimen of total lymphoid irradiation, fludarabine, cyclophosphamide, granulocyte colony stimulating factor (G-CSF), thiotepa, and melphalan. This is followed by infusions of donor cells that have been prepared using the CliniMACS system: HPC,A (CD34+ selected), HPC,A (CD45RA depleted), and TC-NK.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplant Recipients | Experimental | Participants undergo a preparative regimen of total lymphoid irradiation, fludarabine, cyclophosphamide, fludarabine, thiotepa, melphalan, and mycophenolate mofetil, followed by HPC,A infusion and TC-NK infusion. They also receive G-CSF and mesna. Cells for infusion are prepared using the CliniMACS System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Lymphoid Irradiation | Radiation | Participants receive total lymphoid irradiation over four doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Transplant Recipients With Successful Engraftment | Neutrophil engraftment will be determined using the parameters put forth by the Center for International Blood and Marrow Registry. Assessments will be made upon review of daily complete blood count and serial chimerism studies. Successful engraftment for the purposes of this objective will be patients who do not experience graft failure. | 42 days post engraftment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Transplant Recipients With Malignant Relapse | Bone marrow studies for disease status evaluation will be performed at 1-year post-transplant. Testing will include a research evaluation for minimal residual disease. | One-year post-transplantation |
| Event-free Survival |
Not provided
Inclusion Criteria - Transplant Recipients:
Inclusion Criteria - Haploidentical Donor:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon M. Triplett, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38937803 | Derived | Naik S, Li Y, Talleur AC, Selukar S, Ashcraft E, Cheng C, Madden RM, Mamcarz E, Qudeimat A, Sharma A, Srinivasan A, Suliman AY, Epperly R, Obeng EA, Velasquez MP, Langfitt D, Schell S, Metais JY, Arnold PY, Hijano DR, Maron G, Merchant TE, Akel S, Leung W, Gottschalk S, Triplett BM. Memory T-cell enriched haploidentical transplantation with NK cell addback results in promising long-term outcomes: a phase II trial. J Hematol Oncol. 2024 Jun 27;17(1):50. doi: 10.1186/s13045-024-01567-0. |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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There are in total 82 transplant recipients enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Transplant Recipients | Participants undergo a preparative regimen of total lymphoid irradiation, fludarabine, cyclophosphamide, fludarabine, thiotepa, melphalan, and mycophenolate mofetil, followed by HPC,A infusion and TC-NK infusion. They also receive G-CSF and mesna. Cells for infusion are prepared using the CliniMACS System. Total Lymphoid Irradiation: Participants receive total lymphoid irradiation over four doses. Fludarabine: Given IV. Cyclophosphamide: Given IV. Thiotepa: Given IV. Melphalan: Given IV. HPC,A Infusion: Participants received infusions of HPC,A (CD34+ selected) and HPC,A (CD45RA depleted). TC-NK Infusion: Participants receive infusions of TC-NK. G-CSF: Participants receive G-CSF subcutaneously or intravenously. Donors receive G-CSF subcutaneously during cell mobilization. Mesna: Mesna is generally dosed at approximately 25% of the cyclophosphamide dose. It is generally given intravenously prior to and again at 3, 6 and 9 hours following each dose of cyclophosphamide. CliniMACS: The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells. Mycophenolate mofetil: Given intravenously or orally. |
| 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 | Oct 11, 2018 |
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Not provided
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| Fludarabine | Drug | Given IV. |
|
|
| Cyclophosphamide | Drug | Given IV. |
|
|
| Thiotepa | Drug | Given IV. |
|
|
| Melphalan | Drug | Given IV. |
|
|
| HPC,A Infusion | Biological | Participants received infusions of HPC,A (CD34+ selected) and HPC,A (CD45RA depleted). |
|
| TC-NK Infusion | Biological | Participants receive infusions of TC-NK. |
|
| G-CSF | Biological | Participants receive G-CSF subcutaneously or intravenously. Donors receive G-CSF subcutaneously during cell mobilization. |
|
|
| Mesna | Drug | Mesna is generally dosed at approximately 25% of the cyclophosphamide dose. It is generally given intravenously prior to and again at 3, 6 and 9 hours following each dose of cyclophosphamide. |
|
|
| CliniMACS | Device | The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells. |
|
|
| Mycophenolate mofetil | Drug | Given intravenously or orally. |
|
|
The one-year event free survival is defined by the patient who has neither experienced relapse nor death within one year after post transplantation. And the rate is calculated by computing the ratio between total number of one year event free survival patients and the total number of patients. |
| One year post-transplantation |
| Overall Survival | The one-year survival is defined by the patient who has not died within one year after post transplantation. And the rate is calculated by computing the ratio between total number of one year survival patients and the total number of patients. | one year post-transplantation |
| Number of Transplant Recipients With Acute and/or Chronic Graft Versus Host Disease (GVHD) | Acute and chronic graft-vs.-host disease will be evaluated using the standard grading criteria. The estimate will be the number of recipients who experienced GVHD divided by the total number of patients considered in this group. | 100 days post-transplant for acute GVHD; one year post-transplant for chronic GVHD . |
| Number of Transplant Recipients With Transplant-related Mortality (TRM) | Estimate the proportion of patients died within 100 days after the transplantation who has not experienced a relapse. The estimate will be the number of TRM divides the total number of patients considered in this group. | In the first 100 days after transplantation |
| Severity of Acute Graft Versus Host Disease (aGVHD) | Ongoing assessment of toxicity will be done using the NCI CTCAE version 3.0. Acute and chronic graft-vs.-host disease will be evaluated using the standard grading criteria. The severity of acute GvHD and chronic GvHD will be described. The analysis for this objective will be performed when the last evaluable participant has been followed for 100 days post transplant. Acute GvHD is graded from 1-4 with 4 being the worst outcome. | 100 days post-transplant for acute GVHD. |
| Severity of Chronic Graft Versus Host Disease (cGVHD) | Ongoing assessment of toxicity will be done using the NCI CTCAE version 3.0. Acute and chronic graft-vs.-host disease will be evaluated using the standard grading criteria. The severity of acute GvHD and chronic GvHD will be described. The analysis for this objective will be performed when the last evaluable participant has been followed for 1 year post-transplant. Chronic GvHD is graded as "mild", "moderate" or "severe" with "severe" being the worst outcome. | 1 year post-transplant for chronic GVHD . |
| Clinical Trials Open at St. Jude | View source |
| COMPLETED |
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| NOT COMPLETED |
|
Age was evaluated at the time of transplantation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Transplant Recipients | Participants meeting eligibility criteria and who completed study therapy: haploidentical stem cell transplantation with additional natural killer (NK) cells and total lymphoid irradiation (TLI) based conditioning regimen. Participants who received a therapeutic variance (maraviroc) are excluded. |
| 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 | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Donor relationship to patient: Father, Mother, Sibling, Other. | 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 Transplant Recipients With Successful Engraftment | Neutrophil engraftment will be determined using the parameters put forth by the Center for International Blood and Marrow Registry. Assessments will be made upon review of daily complete blood count and serial chimerism studies. Successful engraftment for the purposes of this objective will be patients who do not experience graft failure. | Participants meeting eligibility criteria and who completed study therapy: haploidentical stem cell transplantation with additional natural killer (NK) cells and total lymphoid irradiation (TLI) based conditioning regimen. Participants who received a therapeutic variance (maraviroc) are excluded. | Posted | Count of Participants | Participants | 42 days post engraftment |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Transplant Recipients With Malignant Relapse | Bone marrow studies for disease status evaluation will be performed at 1-year post-transplant. Testing will include a research evaluation for minimal residual disease. | Participants meeting eligibility criteria and who completed study therapy: haploidentical stem cell transplantation with additional natural killer (NK) cells and total lymphoid irradiation (TLI) based conditioning regimen. Participants who received a therapeutic variance (maraviroc) are excluded. | Posted | Count of Participants | Participants | One-year post-transplantation |
|
| |||||||||||||||||||||||||||
| Secondary | Event-free Survival | The one-year event free survival is defined by the patient who has neither experienced relapse nor death within one year after post transplantation. And the rate is calculated by computing the ratio between total number of one year event free survival patients and the total number of patients. | Participants meeting eligibility criteria and who completed study therapy: haploidentical stem cell transplantation with additional natural killer (NK) cells and total lymphoid irradiation (TLI) based conditioning regimen. Participants who received a therapeutic variance (maraviroc) are excluded. | Posted | Count of Participants | Participants | One year post-transplantation |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | The one-year survival is defined by the patient who has not died within one year after post transplantation. And the rate is calculated by computing the ratio between total number of one year survival patients and the total number of patients. | Participants meeting eligibility criteria and who completed study therapy: haploidentical stem cell transplantation with additional natural killer (NK) cells and total lymphoid irradiation (TLI) based conditioning regimen. Participants who received a therapeutic variance (maraviroc) are excluded. | Posted | Count of Participants | Participants | one year post-transplantation |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Transplant Recipients With Acute and/or Chronic Graft Versus Host Disease (GVHD) | Acute and chronic graft-vs.-host disease will be evaluated using the standard grading criteria. The estimate will be the number of recipients who experienced GVHD divided by the total number of patients considered in this group. | Participants meeting eligibility criteria and who completed study therapy: haploidentical stem cell transplantation with additional natural killer (NK) cells and total lymphoid irradiation (TLI) based conditioning regimen. Participants who received a therapeutic variance (maraviroc) are excluded. | Posted | Count of Participants | Participants | 100 days post-transplant for acute GVHD; one year post-transplant for chronic GVHD . |
| ||||||||||||||||||||||||||||
| Secondary | Number of Transplant Recipients With Transplant-related Mortality (TRM) | Estimate the proportion of patients died within 100 days after the transplantation who has not experienced a relapse. The estimate will be the number of TRM divides the total number of patients considered in this group. | Participants meeting eligibility criteria and who completed study therapy: haploidentical stem cell transplantation with additional natural killer (NK) cells and total lymphoid irradiation (TLI) based conditioning regimen. Participants who received a therapeutic variance (maraviroc) are excluded. | Posted | Count of Participants | Participants | In the first 100 days after transplantation |
|
| |||||||||||||||||||||||||||
| Secondary | Severity of Acute Graft Versus Host Disease (aGVHD) | Ongoing assessment of toxicity will be done using the NCI CTCAE version 3.0. Acute and chronic graft-vs.-host disease will be evaluated using the standard grading criteria. The severity of acute GvHD and chronic GvHD will be described. The analysis for this objective will be performed when the last evaluable participant has been followed for 100 days post transplant. Acute GvHD is graded from 1-4 with 4 being the worst outcome. | Participants meeting eligibility criteria and who completed study therapy: haploidentical stem cell transplantation with additional natural killer (NK) cells and total lymphoid irradiation (TLI) based conditioning regimen. Participants who received a therapeutic variance (maraviroc) are excluded. | Posted | Count of Participants | Participants | 100 days post-transplant for acute GVHD. |
|
| |||||||||||||||||||||||||||
| Secondary | Severity of Chronic Graft Versus Host Disease (cGVHD) | Ongoing assessment of toxicity will be done using the NCI CTCAE version 3.0. Acute and chronic graft-vs.-host disease will be evaluated using the standard grading criteria. The severity of acute GvHD and chronic GvHD will be described. The analysis for this objective will be performed when the last evaluable participant has been followed for 1 year post-transplant. Chronic GvHD is graded as "mild", "moderate" or "severe" with "severe" being the worst outcome. | Participants meeting eligibility criteria and who completed study therapy: haploidentical stem cell transplantation with additional natural killer (NK) cells and total lymphoid irradiation (TLI) based conditioning regimen. Participants who received a therapeutic variance (maraviroc) are excluded. | Posted | Count of Participants | Participants | 1 year post-transplant for chronic GVHD . |
|
|
Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first-year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, regardless of their relationship to the treatment given. Clinically significant NCI Grade I-II adverse events that are judged to be related/possibly related may be collected per the discretion and judgment of the PI. Adverse events that affected more than 5 participants are included in this description.
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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 | Experimental: Transplant Recipients | Participants meeting eligibility criteria and who completed study therapy: haploidentical stem cell transplantation with additional natural killer (NK) cells and total lymphoid irradiation (TLI) based conditioning regimen. Participants who received a therapeutic variance (maraviroc) are included. | 14 | 78 | 56 | 78 | 78 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Without Neutropenia | Infections and infestations | Non-systematic Assessment |
| ||
| Febrile Neutropenia | Infections and infestations | Non-systematic Assessment |
| ||
| Pericardial Effusion | Cardiac disorders | Non-systematic Assessment |
| ||
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypotension | Cardiac disorders | Non-systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Infection, Staphylococcus Epidermidis, Blood | Infections and infestations | Non-systematic Assessment |
| ||
| Seizure | Nervous system disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Hemorrhage, Pulmonary | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Infections and infestations | Non-systematic Assessment |
| ||
| Mucositis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Infection, Clostridium Difficile, Stool | Infections and infestations | Non-systematic Assessment |
| ||
| Infection, Human Herpesvirus 6, Blood | Infections and infestations | Non-systematic Assessment |
| ||
| Febrile Without Neutropenia | Infections and infestations | Non-systematic Assessment |
| ||
| Infection, Adenovirus, Stool | Infections and infestations | Non-systematic Assessment |
| ||
| Engraftment Syndrome | Immune system disorders | Non-systematic Assessment |
| ||
| Infection, Candida, Oral | Infections and infestations | Non-systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| Infection, Cytomegalovirus, Blood | Infections and infestations | Non-systematic Assessment |
| ||
| Tachycardia (finding) | Cardiac disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Infection, BK Virus, Urine | Infections and infestations | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hemorrhagic Cystitis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hypotension | Cardiac disorders | Non-systematic Assessment |
| ||
| Infection, Rotavirus, Stool | Infections and infestations | Non-systematic Assessment |
| ||
| Cytokine Release Syndrome | Immune system disorders | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Infection, Staphylococcus Epidermidis, Blood | Infections and infestations | Non-systematic Assessment |
| ||
| Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase) (SGPT) level abnormal (finding) | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Diastolic dysfunction (finding) | Cardiac disorders | Non-systematic Assessment |
| ||
| Infection, Adenovirus, Blood | Infections and infestations | Non-systematic Assessment |
| ||
| Infection, Epstein Barr Virus, Blood | Infections and infestations | Non-systematic Assessment |
| ||
| Infection, Adenovirus, Respiratory Tract | Infections and infestations | Non-systematic Assessment |
| ||
| Infection, Norovirus, Stool | Infections and infestations | Non-systematic Assessment |
| ||
| Transaminitis | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Confusion | Nervous system disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Epistaxis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Infection, BK Virus, Blood | Infections and infestations | Non-systematic Assessment |
| ||
| Infection, Streptococcus Viridans, Blood | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumatosis Intestinalis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Weight Loss | Metabolism and nutrition disorders | Non-systematic Assessment |
|
Not provided
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brandon M. Triplett, MD | St. Jude Children's Research Hospital | 866-278-5833 | referralinfo@stjude.org |
| Oct 28, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 11, 2018 | Oct 28, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D003520 | Cyclophosphamide |
| D013852 | Thiotepa |
| D008558 | Melphalan |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| D015080 | Mesna |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Sibling |
|
| Other |
|
|
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|