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| ID | Type | Description | Link |
|---|---|---|---|
| 0612M98727 | Other Identifier | Institutional Review Board, University of Minnesota |
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Transplantation with stem cells is a standard therapy in many centers around the world. Previous experience with stem cell transplantation therapy for leukemias, lymphomas, other cancers, aplastic anemia and other non-malignant diseases, has led to prolonged disease-free survival or cure for some patients. However, the high doses of pre-transplant radiation and chemotherapy drugs used, and the type of drugs used, often cause many side effects that are intolerable for some patients. Slow recovery of blood counts is a frequent complication of high dose pre-transplant regimens, resulting in a longer period of risk for bleeding and infection plus a longer time in the hospital.
Recent studies have shown that using lower doses of radiation and chemotherapy (ones that do not completely kill all of the patient's bone marrow cells) before blood or bone marrow transplant, may be a better treatment for high risk patients, such as those with Dyskeratosis Congenita (DC) or Severe Aplastic Anemia(SAA). These low dose transplants may result in shorter periods of low blood counts, and blood counts that do not go as low as with traditional pre-transplant radiation and chemotherapy. Furthermore, in patients with Dyskeratosis Congenita or SAA, the stem cell transplant will replace the blood forming cells with healthy cells.
It has recently been shown that healthy marrow can take and grow after transplantation which uses doses of chemotherapy and radiation that are much lower than that given to patients with leukemia. While high doses of chemotherapy and radiation may be necessary to get rid of leukemia, this may not be important to patients with Dyskeratosis Congenita or SAA. The purpose of this research is to see if this lower dose chemotherapy and radiation regimen followed by transplant is a safe and effective treatment for patients with Dyskeratosis Congenita or SAA.
This is an open label, single arm, phase II clinical trial designed to evaluate the safety and efficacy of the treatment regimen. Efficacy will be measured by long-term engraftment of the transplanted cells.The primary endpoint of neutrophil engraftment is defined as an absolute neutrophil count (ANC) >5 x 108/L (first of three consecutive laboratory measurements on different days) with at least 10% donor cells by day 100. We will evaluate the proportion of success (P) and its 95% confidence interval (CI) for the entire group. The null hypothesis of 90% engraftment will be rejected if 4 or more patients fail to engraft out of 15 evaluable patients. The secondary endpoints of regimen related mortality, acute and chronic graft-versus-host disease (GVHD) and secondary malignancies will be estimated by cumulative incidence treating non-event deaths as a competing risk. Survival will be estimated by Kaplan-Meier methods. Immune reconstitution will be summarized with descriptive statistics.
SAA and DC arms will be analyzed separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with DC | Experimental | Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation. |
|
| Patients with SAA | Experimental | Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Campath 1H | Drug | 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neutrophil Engraftment | Defined as an absolute neutrophil count (ANC) >5 x 10^8/L (first of three consecutive laboratory measurements on different days) with at least 10% donor cells by day 100. Demonstrate sustained engraftment after a fludarabine based preparative regimen in patients with dyskeratosis congenita followed by hematopoietic cell transplantation. | Day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Regimen Related Mortality at 100 Days | all deaths without previous relapse or progression | 100 days |
| Incidence of Chronic GVHD | Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. |
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Inclusion Criteria:
Patients with dyskeratosis congenita (DC) or severe aplastic anemia (SAA) 0-70 years of age with an acceptable hematopoietic stem cell (HSC) donor
HSC source
Disease Characteristics for DC (both of the following):
Evidence of BM failure:
Diagnosis of DC:
Disease Characteristics for SAA (both of the following):
Evidence of BM failure:
Diagnosis of SAA:
Patients with early myelodysplastic features.
Patients with or without clonal cytogenetic abnormalities.
Patient Exclusion Criteria:
Patients with one or more of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Jakub Tolar, M.D., Ph.D. | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20383216 | Derived | Dietz AC, Orchard PJ, Baker KS, Giller RH, Savage SA, Alter BP, Tolar J. Disease-specific hematopoietic cell transplantation: nonmyeloablative conditioning regimen for dyskeratosis congenita. Bone Marrow Transplant. 2011 Jan;46(1):98-104. doi: 10.1038/bmt.2010.65. Epub 2010 Apr 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With DC | Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation. Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours). Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours). Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour) Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given Stem Cell Transplantation: Infusion of stem cells on Day 0. |
| FG001 | Patients With SAA | Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin (ATG), total body irradiation and stem cell transplantation. Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours). Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour) Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given Stem Cell Transplantation: Infusion of stem cells on Day 0. antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days. Methylprednisolone: 2mg/kg IV is given before each dose of ATG. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With DC | Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation. Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours). Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours). Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour) Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given Stem Cell Transplantation: Infusion of stem cells on Day 0. |
| 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 |
| 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 | Neutrophil Engraftment | Defined as an absolute neutrophil count (ANC) >5 x 10^8/L (first of three consecutive laboratory measurements on different days) with at least 10% donor cells by day 100. Demonstrate sustained engraftment after a fludarabine based preparative regimen in patients with dyskeratosis congenita followed by hematopoietic cell transplantation. | Posted | Count of Participants | Participants | Day 100 |
|
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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 | Patients With DC | Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation. Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours). Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours). Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour) Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given Stem Cell Transplantation: Infusion of stem cells on Day 0. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adult Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Brain Infarction | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jakub Tolar, MD | Masonic Cancer Center, University of Minnesota | tolar003@umn.edu |
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| ID | Term |
|---|---|
| D019871 | Dyskeratosis Congenita |
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D000080984 | Congenital Bone Marrow Failure Syndromes |
| D000080983 | Bone Marrow Failure Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D014916 | Whole-Body Irradiation |
| D011878 | Radiotherapy |
| D033581 | Stem Cell Transplantation |
| D016026 | Bone Marrow Transplantation |
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Cyclophosphamide | Drug | 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours). |
|
|
| Fludarabine | Drug | 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour) |
|
|
| Total Body Irradiation | Procedure | 1 day before the transplant one dose (200 cGy) of total body irradiation is given |
|
|
| Stem Cell Transplantation | Procedure | Infusion of stem cells on Day 0. |
|
|
| antithymocyte globulin | Drug | ATG (rabbit) 3 mg/kg for 3 days. |
|
|
| Methylprednisolone | Drug | 2mg/kg IV is given before each dose of antithymocyte globulin (ATG). |
|
| 6 months |
| Incidence of Chronic GVHD | Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. | 1 year |
| Incidence of Late Secondary Malignancies | Defined as patients who have a secondary malignancy (cancer) occurring. | 1 Year |
| Incidence of Grade 2-4 Acute Graft Versus Host Disease (GVHD) | Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. | Day 100 |
| Incidence of Grade 3-4 Acute Graft Versus Host Disease (GVHD) | Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. | Day 100 |
| Overall Survival | Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive. | Day 100 |
| Overall Survival | Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive. | 1 Year |
| Incidence of Pulmonary Complications | Defined as patients who exhibit a pulmonary (lung) adverse event. | 6 Months |
| BG001 | Patients With SAA | Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation. Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours). Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour) Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given Stem Cell Transplantation: Infusion of stem cells on Day 0. antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days. Methylprednisolone: 2mg/kg IV is given before each dose of ATG. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Patients With SAA | Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation. Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours). Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour) Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given Stem Cell Transplantation: Infusion of stem cells on Day 0. antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days. Methylprednisolone: 2mg/kg IV is given before each dose of ATG. |
|
|
| Secondary | Incidence of Regimen Related Mortality at 100 Days | all deaths without previous relapse or progression | Posted | Count of Participants | Participants | 100 days |
|
|
|
| Secondary | Incidence of Chronic GVHD | Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Incidence of Chronic GVHD | Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Incidence of Late Secondary Malignancies | Defined as patients who have a secondary malignancy (cancer) occurring. | Posted | Count of Participants | Participants | 1 Year |
|
|
|
| Secondary | Incidence of Grade 2-4 Acute Graft Versus Host Disease (GVHD) | Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. | Posted | Count of Participants | Participants | Day 100 |
|
|
|
| Secondary | Incidence of Grade 3-4 Acute Graft Versus Host Disease (GVHD) | Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. | Posted | Count of Participants | Participants | Day 100 |
|
|
|
| Secondary | Overall Survival | Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive. | Posted | Count of Participants | Participants | Day 100 |
|
|
|
| Secondary | Overall Survival | Overall survival is defined as time from date of transplant to date of death or censored at the date of last documented contact for patients still alive. | Posted | Count of Participants | Participants | 1 Year |
|
|
|
| Secondary | Incidence of Pulmonary Complications | Defined as patients who exhibit a pulmonary (lung) adverse event. | Posted | Count of Participants | Participants | 6 Months |
|
|
|
| 2 |
| 15 |
| 15 |
| 15 |
| EG001 | Patients With SAA | Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation. Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours). Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour) Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given Stem Cell Transplantation: Infusion of stem cells on Day 0. antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days. Methylprednisolone: 2mg/kg IV is given before each dose of ATG. | 1 | 21 | 20 | 21 |
| Intracranial Hemorrhage | Nervous system disorders |
|
| Pulmonary Failure | Respiratory, thoracic and mediastinal disorders |
|
| Renal Failure | Renal and urinary disorders |
|
| Acute Kidney Injury | Renal and urinary disorders |
|
| Acute Pancreatitis | Gastrointestinal disorders |
|
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders |
|
| Aseptic/Avascular Necrosis | Musculoskeletal and connective tissue disorders |
|
| Atrial Fibrillation | Cardiac disorders |
|
| Blood Infection | Infections and infestations |
|
| Bone Marrow Biopsy Site Infection | Infections and infestations |
|
| Bone Marrow Infection | Infections and infestations |
|
| Capillary Leak Syndrome | Vascular disorders |
|
| Cellulitis | Infections and infestations |
|
| Coagulopathy | Investigations |
|
| Colitis | Infections and infestations |
|
| Congestive Heart Failure | Cardiac disorders |
|
| Cystitis | Renal and urinary disorders |
|
| Cytopenias | Blood and lymphatic system disorders |
|
| Deep Vein Thrombosis | Vascular disorders |
|
| Ear Infection | Infections and infestations |
|
| Early Small Bowel Obstruction vs. Ileus | General disorders |
|
| Epstein Barr Virus Infection | Infections and infestations |
|
| Erythema at Central Line Site | Skin and subcutaneous tissue disorders |
|
| Erythroid Aplasia | Blood and lymphatic system disorders |
|
| Eye Infection | Infections and infestations |
|
| Fever | General disorders |
|
| Fever with Chills | General disorders |
|
| Folliculitis | Skin and subcutaneous tissue disorders |
|
| Gallstones | Hepatobiliary disorders |
|
| GI Bleed | Gastrointestinal disorders |
|
| GI Infection | Infections and infestations |
|
| Hemorrhagic Pancreatitis | Gastrointestinal disorders |
|
| Herpes Zoster | Infections and infestations |
|
| Hyperglycemia | Metabolism and nutrition disorders |
|
| Hypertension | Vascular disorders |
|
| Hypogonadism | Endocrine disorders |
|
| Hypotension | Vascular disorders |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Infection at Central Line Site | Infections and infestations |
|
| Labia Infection | Infections and infestations |
|
| Low Reticulocyte Count | Blood and lymphatic system disorders |
|
| Lung Collapse | Respiratory, thoracic and mediastinal disorders |
|
| Meningitis | Nervous system disorders |
|
| Multi Organ Failure | General disorders |
|
| Nasal Infection | Respiratory, thoracic and mediastinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Anorexia | Gastrointestinal disorders |
|
| Neuropathy | Nervous system disorders |
|
| Brain Lesion, Nonspecific | Nervous system disorders |
|
| Nose Bleeds | Respiratory, thoracic and mediastinal disorders |
|
| Otomastoiditis | Ear and labyrinth disorders |
|
| Pericardial Effusion | Cardiac disorders |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| Intra-Abdominal Infection, Unconfirmed | Infections and infestations |
|
| Pulmonary Hypertension | Cardiac disorders |
|
| Post Transplant Lymphoproliferative Disease | Blood and lymphatic system disorders |
|
| Pulmonary Hemorrhage | Respiratory, thoracic and mediastinal disorders |
|
| Pustular Rash | Skin and subcutaneous tissue disorders |
|
| Pyelocaliectasis | Renal and urinary disorders |
|
| Renal Injury Requiring Dialysis | Renal and urinary disorders |
|
| Respiratory Infection | Infections and infestations |
|
| Retinal Hemorrhage | Eye disorders |
|
| Seizure | Nervous system disorders |
|
| Sepsis | Infections and infestations |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders |
|
| Skin Infection | Infections and infestations |
|
| Spongiotic Dermatitis | Skin and subcutaneous tissue disorders |
|
| Tonsilar Infection | Infections and infestations |
|
| Transaminitis | Investigations |
|
| Urinary Tract Infection | Infections and infestations |
|
| Vaginal Infection | Infections and infestations |
|
| Veno-Occlusive Disease | Hepatobiliary disorders |
|
| Vocal Fold Erythema and Leukoplakia | Respiratory, thoracic and mediastinal disorders |
|
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| D006425 | Hemic and Lymphatic Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000740 | Anemia |
| 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 |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D016378 | Tissue Transplantation |
| D007106 | Immune Sera |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |