Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 97355 | Other Identifier | Stanford University alternate IRB Number | |
| BMT186 | Other Identifier | OnCore number |
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Low accrual
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The purpose of this study is to determine if double autologous then allogeneic hematopoietic cell transplant may offer an improved treatment option for patients with relapsed diffuse large B-cell lymphoma (DLBCL) who are not likely to be cured by the conventional transplantation regimen.
This study tests a tandem transplant approach that starts with transplantation of the participant's own hematopoietic (blood) cells, eg, autologous hematopoietic cell transplant (auto-HCT) as preparation for an subsequent matched-donor allogeneic HCT (allo-HCT).
Participants will be have progenitor cells (stem cells) mobilized into the peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim (G-CSF); undergo apheresis to collect autologous peripheral blood stem cells (PBSC, aka hematopoietic cells); and be re-infused with ≥ 3 x 10e6 CD34+ cells/kg (auto-HCT). Subsequently, participants will receive therapeutic, non-myeloablative chemotherapy (carmustine + cyclophosphamide + etoposide), then transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by ≥ 2 x 10e6 CD34+ cells/kg allogeneic PBSC obtained from a human leukocyte antigen (HLA)-matched or HLA single allele / antigen-mismatched donor (allo-HCT). Donors will be mobilized with 16 µg/kg filgrastim. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT infusion treatment includes cyclosporine and mycophenolate mofetil (MMF)
Subject's participation ends if a suitable matched donor is not identified within the 150 days.
Pre-medication treatments administered during this study may include acetaminophen; diphenhydramine; hydrocortisone; and methylprednisolone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auto-HCT followed by Allo-HCT for Poor-risk DLBCL | Experimental | Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT). Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF). Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous hematopoietic stem cell transplantation (auto-HSCT) | Procedure | Auto-HCT involves an intravenous infusion of a participant's previously collected and frozen white blood cells collected after treatment with mobilizing agents |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) Per Protocol | Event-free survival (EFS) through 4 years, as assessed in participants with poor-risk recurrent or primary refractory DLBCL treated with TLI and ATG followed by matched allogeneic hematopoietic cell transplantation as a consolidation to HCT. Event is defined as tumor progression or death. | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Neutrophil Engraftment After Autologous Transplant | Reported as neutrophil engraftment after autologous transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant. | within 1 month |
| Median Time to Platelet Engraftment After Autologous Transplant |
Not provided
INCLUSION CRITERIA
Age 18 to 70 years.
Histologically-proven diffuse large B-cell lymphoma (DLBCL) by the World Health Organization (WHO) classification.
Relapse after achieving initial remission or failure to achieve initial remission. Patients with residual radiographic abnormalities after primary therapy are eligible if abnormalities are postive by fluorodeoxyglucose (FDG)-positron emission tomography (PET) (FDG-PET).
Receipt of 2 cycles of second-line therapy and FDG-PET positive per Stanford (central) review. FDG-PET to be done 2 weeks after cycle 2 of second line chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status < 2
Matched related or unrelated donor identified and available
Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration
Pretreatment serum bilirubin < 2 x the institutional upper limit of normal (ULN)
Serum creatinine < 2 x the institutional ULN and measured or estimated creatinine clearance > 60 mL/min by the following formula (all tests must be performed within 28 days prior to registration):
EKG within 42 days prior to registration with no significant abnormalities suggestive of active cardiac disease
Patients must have a radionuclide ejection fraction within 42 days of registration. If the ejection fraction is < 40%, the patient will not be eligible. If the ejection fraction is 40-50%, the patient will have a cardiology consult.
Corrected diffusion capacity > 55%.
Sexually active males are advised to use an accepted and effective method of birth control
Women of child-bearing potential are advised to use an accepted and effective method of birth control
Patients must sign and give written informed consent in accordance with institutional and federal guidelines. Patients must be informed of the investigational nature of this study.
EXCLUSION CRITERIA
DONOR ELIGIBILITY
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| Name | Affiliation | Role |
|---|---|---|
| Wen-Kai Weng | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL | Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT). Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF). Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Autologous Peripheral Stem Cells |
|
Not provided
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|
| Allogeneic hematopoietic stem cell transplantation (allo-HSCT) | Procedure | Allo-HCT involves an intravenous infusion of a donor's white blood cells collected after treatment with mobilization with filgrastim (G-CSF) |
|
|
| Total lymphoid irradiation (TLI) | Procedure | TLI is administered in 80cGy fractions on Days -11 to Day-7 relative to allo-HSCT |
|
| Rituximab | Drug | 375 mg/m2 IV days 1 and 7 over 4 to 8 hours |
|
|
| Carmustine | Drug | Based on body weight, unless its more than 15 kg greater than the idal body 15mg/kg (max dose 550 mg/m2) day -6 over 2 hours. Males IBW = 50 kg + 2.3 kg/inch over 5 feet Females IBW = 45.5 kg + 2.3 kg/inch over 5 feet Adjusted IBW = IBW + 50% (actual weight - IBW) |
|
|
| Etoposide | Drug | 60 mg/kg over 4 hours day -4 and alternatively VP-16 2 Gm/m² may be used (for mobilization) |
|
|
| Filgrastim | Drug | 10 µg/kg/day subcutaneous starting Day 9 until last day of apheresis. 5 ug/kg actual body weight per day will be started at Day +6 after allo-HCT until hematologic recovery |
|
|
| Anti-thymocyte globulin (ATG) | Drug | 1.5 mg/kg/day for 5 days |
|
| Cyclosporine | Drug | 5.0 mg/kg twice daily from day -3 until after day +56 |
|
|
| Mycophenolate mofetil (MMF) | Drug | 250 mg (total) twice daily, oral 15 mg/kg po on day 0, at 5-10 hours after mobilized PBPC infusion is complete. On day +1 MMF is taken at 15 mg/kg po b.i.d. (30 mg/kg/day) if transplantation was using a matched related donor and 15 mg/kg po t.i.d if from a matched unrelated donor or a one antigen mismatched donor. |
|
|
| Cyclophosphamide | Drug | 100 mg/kg will be administered over 2 hours on day -2 |
|
|
| Acetaminophen | Drug | Pre-medication for rituximab and PBPC infusion. Administered at 650 mg by mouth 1 hour prior to infusion |
|
|
| Diphenhydramine | Drug | Pre-medication for rituximab and PBPC infusion. Administered at 50 mg intravenous 1 hour prior to infusion |
|
|
| Hydrocortisone | Drug | Pre-medication for the PBPC infusion. Administered at 100 mg intravenous 1 hour prior to infusion |
|
|
| Methylprednisolone | Drug | Anti-reaction medication for the ATG infusion. Administered at 1 mg/kg, Day-11 to Day-7 |
|
|
Reported as platelet engraftment after autologous transplant, defined as platelet count > 20,000/µL, counting from the day of transplant. |
| within 1 month |
| Median Time to Neutrophil Engraftment After Allogeneic Transplant | Reported as neutrophil engraftment after allogeneic transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant. | within 1 month |
| Median Time to Platelet Engraftment After Allogeneic Transplant | Reported as platelet engraftment after allogeneic transplant, defined as platelet count > 20,000/µL, counting from the day of transplant. | within 1 month |
| Incidence of Chronic Graft vs Host Disease (GvHD) | The incidence of chronic graft vs host disease (GvHD) is reported as any events within 3 years. Note that GvHD was assessed per investigator judgement. There was no protocol-specified criteria of GvHD. | 3 years |
| Overall Survival (OS) | To evaluate the overall and transplant related mortality rate, reported as the number of subjects remaining alive 3 years after transplant. | 3 years |
| COMPLETED |
|
| NOT COMPLETED |
|
| Inter-treatment Period |
|
|
| Allogeneic Peripheral Stem Cells |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL | Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT). Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF). Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone. |
| 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 |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | 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 | Event-free Survival (EFS) Per Protocol | Event-free survival (EFS) through 4 years, as assessed in participants with poor-risk recurrent or primary refractory DLBCL treated with TLI and ATG followed by matched allogeneic hematopoietic cell transplantation as a consolidation to HCT. Event is defined as tumor progression or death. | Reported data values are limited by protocol-specified upper boundary for the timeframe of this assessment. | Posted | Median | 95% Confidence Interval | months | 48 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Median Time to Neutrophil Engraftment After Autologous Transplant | Reported as neutrophil engraftment after autologous transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant. | Posted | Median | Full Range | Days | within 1 month |
|
| |||||||||||||||||||||||||||
| Secondary | Median Time to Platelet Engraftment After Autologous Transplant | Reported as platelet engraftment after autologous transplant, defined as platelet count > 20,000/µL, counting from the day of transplant. | Posted | Median | 95% Confidence Interval | Days | within 1 month |
|
| |||||||||||||||||||||||||||
| Secondary | Median Time to Neutrophil Engraftment After Allogeneic Transplant | Reported as neutrophil engraftment after allogeneic transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant. | Posted | Median | Full Range | Days | within 1 month |
|
| |||||||||||||||||||||||||||
| Secondary | Median Time to Platelet Engraftment After Allogeneic Transplant | Reported as platelet engraftment after allogeneic transplant, defined as platelet count > 20,000/µL, counting from the day of transplant. | Note: all participants engrafted platelets on the same day (see below for data values). | Posted | Median | Full Range | Days | within 1 month |
|
| ||||||||||||||||||||||||||
| Secondary | Incidence of Chronic Graft vs Host Disease (GvHD) | The incidence of chronic graft vs host disease (GvHD) is reported as any events within 3 years. Note that GvHD was assessed per investigator judgement. There was no protocol-specified criteria of GvHD. | Posted | Count of Participants | Participants | 3 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | To evaluate the overall and transplant related mortality rate, reported as the number of subjects remaining alive 3 years after transplant. | Posted | Count of Participants | Participants | 3 years |
|
|
3 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 | Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL | Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT). Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF). Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone. | 3 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet count decrease | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Recurrent lymphoma | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | Includes progressive lymphoma |
|
| lymph nodes | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | left groin |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thrush | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteremia | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| facial cellulitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | Includes: Febrile Neutropenia |
|
| Headache | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypermetabolic lymphadenopathy | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | In the necksupraclavicular area, axilla, chest wall, and groin. |
|
| Leukopenic | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Maculo-papular rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Residual disease | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | in the left groin |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thrush | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wen-Kai Weng, Assistant Professor of Medicine | Stanford University Medical Center | 650-723-7689 | wkweng@stanford.edu |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D014180 | Transplantation |
| D000069283 | Rituximab |
| D002330 | Carmustine |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000961 | Antilymphocyte Serum |
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| D003520 | Cyclophosphamide |
| D000082 | Acetaminophen |
| D004155 | Diphenhydramine |
| D006854 | Hydrocortisone |
| D008775 | Methylprednisolone |
| D008776 | Methylprednisolone Hemisuccinate |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| 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 |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| D007106 | Immune Sera |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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 |
|
|
|
|
| Participants |
|
|
|
|
|