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| ID | Type | Description | Link |
|---|---|---|---|
| 75190 | Other Identifier | Stanford University Alternate IRB Approval No. | |
| BMT109 | Other Identifier | OnCore |
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Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host disease (GvHD) during the mixed chimerism period and use donor lymphocyte infusions to convert the patient to a full chimera while developing a graft-vs-tumor effect.
Participants are mobilized with cyclophosphamide 4 g/m2 and filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (auto-HCT)]. Post-infusion support includes filgrastim 5 µg/kg/day, starting 6 days following melphalan. Participants with stable or responsive disease at 4 weeks eligible to continue on to the planned allogenic HCT (allo-HCT). For allo-HCT, a sibling donor that is fully matched for human leukocyte antigen (HLA-matched) is identified. Participants receive a single dose of total body irradiation (TBI) 200 centigray (cGy) as well as immunosuppression with cyclosporine (CSP) 6.25 mg/kg and mycophenolate mofetil (MMF) 15 mg/kg. The HLA-matched donor begins filgrastim injections 16 µg/kg/day on day -4 continuing to Day 0, with apheresis collections on Day -1 and Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV and diphenhydramine 50 mg IV. CSP will be tapered beginning Day 56 with a goal of discontinuing CSP on Day 180, adjusted as needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auto- then Allo-HCT | Experimental | Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous hematopoietic cell transplant (Auto-HCT) | Procedure | The target cell dose is 2.6 x 10e6 CD34+ cells/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) | Event-free survival (EFS) as determined for all participants who received the initial Auto-HCT treatment. "Event" was defined as any of the following within 3 years of the participant's last infusion of Auto-HCT or Allo-HCT: relapse; death; or last follow-up if there is no data to document the participant remained alive at 3 years. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Rate | Relapse rate as determined for all participants who received the initial Auto-HCT treatment. Relapse was protocol-specified as progressive disease, indicated by an increase as compared to pre-Auto-HCT baseline, of serum or urine monoclonal protein >25%; bone marrow plasmacytosis >25%; or bone lesions on skeletal survey (any increase). | 3 years |
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PATIENT INCLUSION CRITERIA
PATIENT EXCLUSION CRITERIA
ALLOGENEIC DONOR INCLUSION CRITERIA
ALLOGENEIC DONOR EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Wen-Kai Weng, MD | 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- Then Allo-HCT | Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Autologous HCT (Auto-HCT) |
|
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| Allogeneic hematopoietic cell transplant (Allo-HCT) | Procedure | The target cell dose is 5 x 10e6 CD34 cells/kg |
|
| Cyclophosphamide | Drug | Cyclophosphamide administered intravenously (IV) at 4 mg /m² mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion |
|
|
| Filgrastim | Drug |
|
|
|
| Melphalan | Drug | Melphalan 200 mg/m2 (high-dose) intravenously as conditioning for Auto-HCT |
|
|
| Total body irradiation (TBI) | Radiation | 200 centigray (cGy) total body irradiation delivered on Day 0 |
|
| Cyclosporine (CSP) | Procedure | Cyclosporine administered twice-daily by mouth at a dose of 6.25 mg/kg from Day -3 through Day 56 |
|
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| Mycophenolate Mofetil (MMF) | Drug | Mycophenolate mofetil will begin at 15 mg/kg twice-daily by mouth from Day 0 to Day 27 |
|
|
| Overall Survival (OS) | Overall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant. | 3 years |
| Acute Graft-vs-Host-Disease (aGvHD) | Development of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT. | 6 months |
| Chronic Graft-vs-Host-Disease (cGvHD) | Development of chronic graft versus host disease (cGvHD) within 3 years, for participants receiving Allo-HCT. Reported as "Extensive cGvHD;" "cGvHD, Not Extensive;" or "No cGvHD," as determined by investigator judgement (no protocol-specified criteria). | 3 years |
| COMPLETED |
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| NOT COMPLETED |
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| Inter-treatment Period |
|
|
| Allogenic HCT (Allo-HCT) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Auto- Then Allo-HCT | Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed. |
| 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) | Event-free survival (EFS) as determined for all participants who received the initial Auto-HCT treatment. "Event" was defined as any of the following within 3 years of the participant's last infusion of Auto-HCT or Allo-HCT: relapse; death; or last follow-up if there is no data to document the participant remained alive at 3 years. | The outcome data are reported as the number of participants who do not experience an EFS event within 3 years from the date of the last transplant, for the "Auto-HCT only" population, the "Auto-HCT then Allo-HCT" population, and the overall study population (ie, "Auto-HCT only" plus +"Auto-HCT then Allo-HCT"). | Posted | Count of Participants | Participants | 3 years |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Relapse Rate | Relapse rate as determined for all participants who received the initial Auto-HCT treatment. Relapse was protocol-specified as progressive disease, indicated by an increase as compared to pre-Auto-HCT baseline, of serum or urine monoclonal protein >25%; bone marrow plasmacytosis >25%; or bone lesions on skeletal survey (any increase). | The outcome data are reported as the number of participants who relapse per criteria within 3 years. | Posted | Number | participants | 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant. | The outcome data are reported as the number of participants who could be documented as remaining alive through 3 years from the date of the last transplant, for the "Auto-HCT only" population, the "Auto-HCT then Allo-HCT" population, and the overall study population (ie, "Auto-HCT only" plus +"Auto-HCT then Allo-HCT"). | Posted | Number | participants | 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Acute Graft-vs-Host-Disease (aGvHD) | Development of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT. | Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT, as determined by investigator judgement (no protocol-specified criteria). | Posted | Count of Participants | Participants | 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Chronic Graft-vs-Host-Disease (cGvHD) | Development of chronic graft versus host disease (cGvHD) within 3 years, for participants receiving Allo-HCT. Reported as "Extensive cGvHD;" "cGvHD, Not Extensive;" or "No cGvHD," as determined by investigator judgement (no protocol-specified criteria). | Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT. | 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 | All Participants Receviing at Least Auto-HCT | Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed. | 21 | 63 | 63 | 63 | 63 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Aspergillosis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pulmonary Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Heart Failure | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cardiopulmonary Failure | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aseptic Encephalitis | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cytomegalovirus | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Coagulase-negative staphylococci | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Disseminated varicella zoster | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Erosive esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fungemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gram-negative bacillary bacteremia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Herpetic stomatitis | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Klebsiella bacteremia | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lung Aspergillosis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decrease | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pseudomonas bacteremia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rhabdomyositis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Right Parietal Encephalocele | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Respiratory syncytial virus pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Superior Vena Cava Syndrome | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Viral Pneumonitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ascites | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cellulitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cytomegalovirus | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Coagulase-negative staphylococci | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehyration | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Disseminated varicella zoster | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Herpes Zoster | Nervous 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 |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Parainfluenza pneumonitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decrease | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Seborrheic dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Steroid Myopathy | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Transaminitis | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thrombotic Thrombocytopenic Purpura | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Viral bronchitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Viral Pneumonitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wen-Kai Weng, MD; Associate Professor of Medicine | Stanford University School of Medicine | 650-723-7689 | wkweng@stanford.edu |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D008558 | Melphalan |
| D014916 | Whole-Body Irradiation |
| D016572 | Cyclosporine |
| 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 |
| 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 |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| All Participants |
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