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The purpose of this study is to learn if it is possible and safe to treat persons with severe sickle cell disease (SCD) by bone marrow transplant (BMT) from human leukocyte antigen (HLA) half-matched related donors. Preparation before transplant includes the chemotherapy drugs hydroxyurea, fludarabine, thiotepa, anti-thymocyte globulin, and cyclophosphamide. It also includes radiation.
The purpose of this study is to learn if it is possible and safe to treat persons with severe sickle cell disease (SCD) by bone marrow transplant (BMT) from human leukocyte antigen (HLA) half-matched related donors. Preparation before transplant includes the chemotherapy drugs hydroxyurea, fludarabine, thiotepa, anti-thymocyte globulin, and cyclophosphamide. It also includes radiation.
Investigators also seek to understand the side effects of BMT in adolescents and young adults with SCD and measure how often serious side effects occur including those that are expected and unexpected. After transplant, investigators will measure the health of the body organs that ordinarily would have been damaged by having SCD in addition to testing the lungs, brain, and kidneys.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone Marrow Recipient | Experimental | Single arm open label study: Participants with sickle cell disease (SCD) will receive bone marrow from a human leukocyte antigen (HLA) mismatched donor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow Transplant (BMT) | Procedure | Participants will receive a bone marrow infusion from a human leukocyte antigen (HLA) mismatched donor through a central venous catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) Rate | Event-free Survival (EFS) is defined as the survival with stable donor erythropoiesis with no new clinical evidence of sickle cell disease (SCD). Primary or late graft rejection with disease recurrence or death will count as events for this endpoint. | Up to One Year |
| Primary Graft Rejection Rate | Primary graft rejection is defined as the absence of donor cells assessed by peripheral blood chimerism assays on day 42. Primary graft rejection can be accompanied by pancytopenia and marrow aplasia or by autologous hematopoietic reconstitution without aplasia. | Day 42 |
| Late Graft Rejection Rate | The absence of donor hematopoietic cells in peripheral blood beyond day 42 up to 1 year in a patient who had initial evidence of hematopoietic recovery with > 20% donor cells will be considered a late graft rejection. | Day 42 Post transplant up to 1 year |
| Rate of Disease Recurrence | Disease recurrence is defined as the return of sickle erythropoiesis (HbS level > 70%) and the absence of donor cell representation. | Up to One Year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate | Overall survival is defined as survival with or without sickle cell disease (SCD) after hematopoietic cell transplantation (HCT). | Up to One Year |
| Cumulative Incidence of Neutrophil Engraftment and Platelet Engraftment. |
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Inclusion Criteria:
Disease severity: Participants with SCD who have 1 or more of the following (i-v).
Age: Patients must be 15 - 40 years of age inclusive OR if younger than 15 years must be pubertal
Adequate physical function as measured by:
Suitable Donor: To undergo transplantation on this study, participants must have an adult first degree relative who shares at least 1 human leukocyte antigen (HLA) haplotype with the participant, does not have SCD or other hemoglobinopathy, and is in good health; if these criteria are met, they will be allowed to serve as donors. Relatives with sickle cell trait are not excluded as donors. When more than 1 donor is available, the donor with the fewest HLA allele mismatches will be chosen, unless the patient had donor anti-HLA antibodies or there was a medical reason to exclude the donor. If donor anti-HLA antibodies are detected, the next best related match will be chosen. Umbilical cord blood or peripheral blood stem cell donors will not be accepted.
Exclusion Criteria:
Donor Selection Criteria:
Preference will be given to related marrow donors who are 2-4 (out of 8) HLA antigen mismatched and towards whom the recipient does not have donor specific antibodies. Donors will sign an informed consent disclosing that the marrow donation will be used by a patient participating in this study. The donor must be matched with the recipient for at least 4 of 8 HLA alleles (HLA -A, -B, -C and -DRB1 by allele-level DNA methodology). The target total nucleated cell count (TNC) is 3.5-8.0 x 108/kg of recipient weight. Marrow will be collected without mobilization. Mobilized peripheral blood stem cell (HPC-A) collections will not be permitted. Donors must undergo hemoglobinopathy screening by electrophoresis; donors who have a hemoglobinopathy will be excluded but trait condition is acceptable.
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| Name | Affiliation | Role |
|---|---|---|
| Lakshmanan Krishnamurti, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30033 | United States |
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Donors in this trial were not considered research participants. Donors were consented per standard of care; these consents were obtained by non-research physicians. Demographics and/or other outcomes were not collected on the donors. Donor selection criteria are included in the protocol to specify the donor preference to be studied in this particular transplant recipient group. Donors provided consent disclosing that the marrow donation would be used by a recipient who was in a research study.
Participants were recruited from Children's Healthcare of Atlanta (CHOA) in Atlanta, Georgia, USA. Participant enrollment began July 10, 2019, and all follow up was complete by December 14, 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bone Marrow Recipient | Patients with SCD will receive a Bone Marrow Transplant (BMT) infusion from an HLA-mismatched donor through a central venous catheter. Hydroxyurea (HU): HU is part of the BMT preparative regimen. Dose: 30 mg/kg orally once a day for 90 days (days -100 to -10). HU Dose adjusted in patients weighing >125% IBW. Thiotepa: Thiotepa is part of the BMT preparative regimen. Dosed at 10mg/kg intravenously (IV) over 2 hrs or per institutional guidelines on day -7. Dose adjusted in patients weighing >125% IBW. Fludarabine (FCR) monophosphate: FCR is part of the BMT preparative regimen. FCR given IV: 30 mg/m2/day over a min. of 30 minutes on days -7 to -3 (150 mg/m2 over 5 consecutive days). Dose adjusted in patients weighing >125% IBW. Cyclophosphamide (CP): CP is part of the BMT preparative regimen. Given over 1-2 hrs on days -6 and -5 prior to BMT infusion at a dose of 14.5 mg/kg IV. Post BMT infusion CP is infused over 1-2 hrs on days +3 (60- and 72-hrs post BMT infusion) and +4 (approx. 24 hrs after day +3 dose) at a dose of 50 mg/kg IV. Dose adjusted in patients weighing >125% IBW. Rabbit Anti-thymocyte Globulin (ATG): Rabbit (ATG) is part of the BMT preparative regimen, an infusion of rabbit-derived antibodies against human T cells used for the prevention of acute rejection in organ transplantation. Rabbit ATG is given on days -9 at 0.5 mg/kg and on days -8 and -7 at 2 mg/kg (4.5 mg/kg). Total Body Irradiation: Participants will receive 200 cGy of TBI in a single fraction. |
| 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 | Sep 22, 2020 |
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| Hydroxyurea | Drug | Hydroxyurea is part of the bone marrow transplant preparative regimen. Hydroxyurea will be administered at a dose of 30 mg/kg orally as a single daily dose for 90 days (from day -100 to day-10). Hydroxyurea dosing will be based on adjusted body weight in participants weighing >125% ideal body weight. |
|
| Thiotepa | Drug | Thiotepa is part of the bone marrow transplant preparative regimen. Thiotepa will be administered at a dose of 10mg/kg intravenously (IV) over 2 hours or per institutional guidelines on day -7. Thiotepa dosing will be based on adjusted body weight in patients weighing >125% ideal body weight. |
|
| Fludarabine monophosphate | Drug | Fludarabine is part of the bone marrow transplant preparative regimen. Fludarabine 30 mg/m2/day will be administered from day -7 to day -3 (for a total of 150 mg/m2 over 5 consecutive days) and administered intravenously (IV) over a minimum of 30 minutes. In participants weighing > 125% ideal body weight, fludarabine will be dose based upon adjusted body weight. |
|
| Cyclophosphamide | Drug | Cyclophosphamide is part of the bone marrow transplant preparative regimen. Cyclophosphamide will be administered on days -6 and -5 prior to bone marrow infusion at a dose of 14.5 mg/kg intravenously (IV) infused over 1-2 hours. Post bone marrow infusion cyclophosphamide will be infused on days +3 (between 60 and 72 hours post marrow infusion) and +4 (approximately 24 hours after day +3 dose) at a dose of 50 mg/kg IV infused over 1-2 hours. For participants weighing more than 125% of their ideal body weight, dosing will be based on adjusted ideal body weight. |
|
| Rabbit Anti-thymocyte Globulin | Other | Rabbit anti-thymocyte globulin (ATG) is part of the bone marrow transplant preparative regimen. It is an infusion of rabbit-derived antibodies against human T cells used for prevention of acute rejection in organ transplantation. Rabbit ATG will be administered on day -9 at 0.5 mg/kg and on days -8 and -7 at 2 mg/kg (for a total dose 4.5 mg/kg). |
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| Total Body Irradiation | Radiation | Participants will receive 200 cGy of TBI in a single fraction. |
|
Cumulative incidence of Neutrophil Engraftment and Platelet Engraftment. Neutrophil engraftment is defined as the first of 3 measurements on different days when the patient has an absolute neutrophil count of ≥ 500/µL after conditioning.
Platelet engraftment is defined as the first day of a minimum of 3 measurements on different days that the patient has achieved a platelet count > 50,000/µL and did not receive a platelet transfusion in the previous 7 days.
| Up to One Year |
| Chimerism Rate Following Hematopoietic Cell Transplantation for Sickle Cell Disease | Genomic DNA extracted from peripheral blood will be analyzed for variable number of tandem repeats (VNTR) to detect donor engraftment in myeloid and lymphoid fractions. | Up to One Year |
| Frequency of Idiopathic Pneumonia Syndrome (IPS) | IPS is diagnosed by evidence of widespread alveolar injury:
| Up to One Year |
| Veno-occlusive Disease (VOD) Rate | VOD is diagnosed by the presence of ≥ 2 of the following with no other identifiable cause for liver disease:
| Up to One Year |
| Rate of Central Nervous System (CNS) Toxicity | CNS toxicity will be defined as seizures, CNS hemorrhage, or PRES. PRES is defined as an increased diffusion coefficient in areas of T2 hyperintensity on diffusion-weighted imaging in the context of clinical symptoms or physical findings including headache, seizures, visual disturbances, and altered level of consciousness. | Up to One Year |
| Infection Rate | Significant infections will be recorded including but not limited to bacterial or fungal sepsis, CMV reactivation with/without clinical disease, adenovirus infection, EBV PTLD, other significant viral reactivations or community-acquired viral infections and invasive mold infections. | Up to One Year |
| Frequency of Stroke | An overt stroke is defined as a focal neurologic event and neurologic deficit lasting > 24 hours with neuroimaging changes. | Up to One Year |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bone Marrow Recipient | Patients with SCD will receive a Bone Marrow Transplant (BMT) infusion from an HLA-matched donor through a central venous catheter. Hydroxyurea (HU): HU is part of the BMT preparative regimen. Dose: 30 mg/kg orally once a day for 90 days (days -100 to -10). HU Dose adjusted in patients weighing >125% IBW. Thiotepa: Thiotepa is part of the BMT preparative regimen. Dosed at 10mg/kg intravenously (IV) over 2 hrs or per institutional guidelines on day -7. Dose adjusted in patients weighing >125% IBW. Fludarabine (FCR) monophosphate: FCR is part of the BMT preparative regimen. FCR given IV: 30 mg/m2/day over a min. of 30 minutes on days -7 to -3 (150 mg/m2 over 5 consecutive days). Dose adjusted in patients weighing >125% IBW. Cyclophosphamide (CP): CP is part of the BMT preparative regimen. Given over 1-2 hrs on days -6 and -5 prior to BMT infusion at a dose of 14.5 mg/kg IV. Post BMT infusion CP is infused over 1-2 hrs on days +3 (60- and 72-hrs post BMT infusion) and +4 (approx. 24 hrs after day +3 dose) at a dose of 50 mg/kg IV. Dose adjusted in patients weighing >125% IBW. Rabbit Anti-thymocyte Globulin (ATG): Rabbit (ATG) is part of the BMT preparative regimen, an infusion of rabbit-derived antibodies against human T cells used for the prevention of acute rejection in organ transplantation. Rabbit ATG is given on days -9 at 0.5 mg/kg and on days -8 and -7 at 2 mg/kg (4.5 mg/kg). Total Body Irradiation: Participants will receive 200 cGy of TBI in a single fraction. |
| 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 |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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) Rate | Event-free Survival (EFS) is defined as the survival with stable donor erythropoiesis with no new clinical evidence of sickle cell disease (SCD). Primary or late graft rejection with disease recurrence or death will count as events for this endpoint. | Posted | Count of Participants | Participants | Up to One Year |
|
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| |||||||||||||||||||||||||||
| Primary | Primary Graft Rejection Rate | Primary graft rejection is defined as the absence of donor cells assessed by peripheral blood chimerism assays on day 42. Primary graft rejection can be accompanied by pancytopenia and marrow aplasia or by autologous hematopoietic reconstitution without aplasia. | Posted | Count of Participants | Participants | Day 42 |
| |||||||||||||||||||||||||||||
| Primary | Late Graft Rejection Rate | The absence of donor hematopoietic cells in peripheral blood beyond day 42 up to 1 year in a patient who had initial evidence of hematopoietic recovery with > 20% donor cells will be considered a late graft rejection. | Posted | Count of Participants | Participants | Day 42 Post transplant up to 1 year |
| |||||||||||||||||||||||||||||
| Primary | Rate of Disease Recurrence | Disease recurrence is defined as the return of sickle erythropoiesis (HbS level > 70%) and the absence of donor cell representation. | Posted | Count of Participants | Participants | Up to One Year |
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate | Overall survival is defined as survival with or without sickle cell disease (SCD) after hematopoietic cell transplantation (HCT). | Posted | Count of Participants | Participants | Up to One Year |
| |||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Neutrophil Engraftment and Platelet Engraftment. | Cumulative incidence of Neutrophil Engraftment and Platelet Engraftment. Neutrophil engraftment is defined as the first of 3 measurements on different days when the patient has an absolute neutrophil count of ≥ 500/µL after conditioning. Platelet engraftment is defined as the first day of a minimum of 3 measurements on different days that the patient has achieved a platelet count > 50,000/µL and did not receive a platelet transfusion in the previous 7 days. | Posted | Count of Participants | Participants | Up to One Year |
| |||||||||||||||||||||||||||||
| Secondary | Chimerism Rate Following Hematopoietic Cell Transplantation for Sickle Cell Disease | Genomic DNA extracted from peripheral blood will be analyzed for variable number of tandem repeats (VNTR) to detect donor engraftment in myeloid and lymphoid fractions. | Posted | Count of Participants | Participants | Up to One Year |
| |||||||||||||||||||||||||||||
| Secondary | Frequency of Idiopathic Pneumonia Syndrome (IPS) | IPS is diagnosed by evidence of widespread alveolar injury:
| Posted | Count of Participants | Participants | Up to One Year |
| |||||||||||||||||||||||||||||
| Secondary | Veno-occlusive Disease (VOD) Rate | VOD is diagnosed by the presence of ≥ 2 of the following with no other identifiable cause for liver disease:
| Posted | Count of Participants | Participants | Up to One Year |
| |||||||||||||||||||||||||||||
| Secondary | Rate of Central Nervous System (CNS) Toxicity | CNS toxicity will be defined as seizures, CNS hemorrhage, or PRES. PRES is defined as an increased diffusion coefficient in areas of T2 hyperintensity on diffusion-weighted imaging in the context of clinical symptoms or physical findings including headache, seizures, visual disturbances, and altered level of consciousness. | Posted | Count of Participants | Participants | Up to One Year |
| |||||||||||||||||||||||||||||
| Secondary | Infection Rate | Significant infections will be recorded including but not limited to bacterial or fungal sepsis, CMV reactivation with/without clinical disease, adenovirus infection, EBV PTLD, other significant viral reactivations or community-acquired viral infections and invasive mold infections. | Posted | Count of Participants | Participants | Up to One Year |
| |||||||||||||||||||||||||||||
| Secondary | Frequency of Stroke | An overt stroke is defined as a focal neurologic event and neurologic deficit lasting > 24 hours with neuroimaging changes. | Posted | Count of Participants | Participants | Up to One Year |
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Data collected up to one year post-transplant.
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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 | Bone Marrow Recipient | Patients with SCD will receive a Bone Marrow Transplant (BMT) infusion from an HLA-matched donor through a central venous catheter. Hydroxyurea (HU): HU is part of the BMT preparative regimen. Dose: 30 mg/kg orally once a day for 90 days (days -100 to -10). HU Dose adjusted in patients weighing >125% IBW. Thiotepa: Thiotepa is part of the BMT preparative regimen. Dosed at 10mg/kg intravenously (IV) over 2 hrs or per institutional guidelines on day -7. Dose adjusted in patients weighing >125% IBW. Fludarabine (FCR) monophosphate: FCR is part of the BMT preparative regimen. FCR given IV: 30 mg/m2/day over a min. of 30 minutes on days -7 to -3 (150 mg/m2 over 5 consecutive days). Dose adjusted in patients weighing >125% IBW. Cyclophosphamide (CP): CP is part of the BMT preparative regimen. Given over 1-2 hrs on days -6 and -5 prior to BMT infusion at a dose of 14.5 mg/kg IV. Post BMT infusion CP is infused over 1-2 hrs on days +3 (60- and 72-hrs post BMT infusion) and +4 (approx. 24 hrs after day +3 dose) at a dose of 50 mg/kg IV. Dose adjusted in patients weighing >125% IBW. Rabbit Anti-thymocyte Globulin (ATG): Rabbit (ATG) is part of the BMT preparative regimen, an infusion of rabbit-derived antibodies against human T cells used for the prevention of acute rejection in organ transplantation. Rabbit ATG is given on days -9 at 0.5 mg/kg and on days -8 and -7 at 2 mg/kg (4.5 mg/kg). Total Body Irradiation: Participants will receive 200 cGy of TBI in a single fraction. | 0 | 6 | 6 | 6 | 0 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-engraftment | Blood and lymphatic system disorders | Non-systematic Assessment | Graft failure happens when the new cells don't make the new white blood cells, red blood cells, and platelets you need. This is also called "failure to engraft" or "non-engraftment. |
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| Central Nervous System Toxicity | Nervous system disorders | Non-systematic Assessment | Posterior reversible encephalopathy syndrome |
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| Graft-versus-host disease (GVHD) | Immune system disorders | Non-systematic Assessment |
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| Thrombotic microangiopathy (TMA) | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Epstein-Barr virus (EBV) | Infections and infestations | Non-systematic Assessment |
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| Deep vein thrombosis (DVT) | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Cytomegalovirus infection (CMV) | Infections and infestations | Non-systematic Assessment |
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| BK virus (BKV) | Infections and infestations | Non-systematic Assessment |
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| Fever | Infections and infestations | Non-systematic Assessment |
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| Bacteriemia | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor of Pediatrics, Dr. Suhag H. Parikh | Emory University | 4047853240 | suhag.parikh@emory.edu |
| Aug 15, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D016026 | Bone Marrow Transplantation |
| D006918 | Hydroxyurea |
| D013852 | Thiotepa |
| C042382 | fludarabine phosphate |
| D003520 | Cyclophosphamide |
| D000961 | Antilymphocyte Serum |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D011878 | Radiotherapy |
| D008919 | Investigative Techniques |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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