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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03670 | Registry Identifier | NCI Clinical Trial Registration Program |
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Blood and marrow stem cell transplant has improved the outcome for patients with high-risk hematologic malignancies. However, most patients do not have an appropriate HLA (immune type) matched sibling donor available and/or are unable to identify an acceptable unrelated HLA matched donor through the registries in a timely manner. Another option is haploidentical transplant using a partially matched family member donor.
Although haploidentical transplant has proven curative in many patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including GVHD and infection due to delayed immune reconstitution. These can, in part, be due to certain white blood cells in the graft called T cells. GVHD happens when the donor T cells recognize the body tissues of the patient (the host) are different and attack these cells. Although too many T cells increase the possibility of GVHD, too few may cause the recipient's immune system to reconstitute slowly or the graft to fail to grow, leaving the patient at high-risk for significant infection.
For these reasons, a primary focus for researchers is to engineer the graft to provide a T cell dose that will reduce the risk for GVHD, yet provide a sufficient number of cells to facilitate immune reconstitution and graft integrity. Building on prior institutional trials, this study will provide patients with a haploidentical (HAPLO) graft engineered to specific T cell target values using the CliniMACS system. A reduced intensity, preparative regimen will be used in an effort to reduce regimen-related toxicity and mortality.
The primary aim of the study is to help improve overall survival with haploidentical stem cell transplant in this high risk patient population by 1) limiting the complication of graft versus host disease (GVHD), 2) enhancing post-transplant immune reconstitution, and 3) reducing non-relapse mortality.
This study will explore the following objectives:
Secondary objectives:
Exploratory objectives:
NOTE: This protocol originally used muromonab (OKT3) in the conditioning regimen to prepare participants for haploidentical HCT. After muromonab became unavailable from the manufacturer in 2010, muromonab was replaced by alemtuzumab (Campath-1H) for use in subsequent participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Risk Hematologic Malignancies | Experimental | Participants meeting eligibility criteria undergo haploidentical stem cell transplantation along with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (after January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF. Grafts from suitable haploidentical donors are processed using the CliniMACS system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CliniMACS | Device | Miltenyi Biotec CliniMACS stem cell selection device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) | To determine if one year event-free survival can be improved in pediatric patients undergoing a haploidentical transplant by using a reduced intensity conditioning regimen and a targeted dose T cell depleted donor product. EFS is defined as time from transplantation to the occurrence of relapse or death due to any cause. Patients who are alive at the time of analysis will be censored. The estimated percentage of participants with EFS at one-year post-transplantation is reported using Kaplan-Meier analysis. | one year post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Estimate the one-year overall survival (OS) for research participants who receive this study treatment. OS is defined as time from transplantation to death due to any cause. Patient who are alive at the time of analysis will be censored. The estimated percentage of participants with OS at one-year post-transplantation is reported using Kaplan-Meier analysis. | one year post-transplant |
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Inclusion Criteria:(transplant recipient)
Patients less than or equal to 21 years of age; may be greater than 21 years old if a current St. Jude patient or previously treated St. Jude patient within 3 years of completion of prior treatment.
Must have one of the following diagnosis:
Has not received a prior allogeneic hematopoietic stem cell transplant.
Does not have a suitable HLA-matched sibling donor available for stem cell donation.
Does not have a suitable cord blood product or volunteer matched unrelated donor (MUD) available in the necessary time for stem cell donation.
Has a suitable HLA partially matched family member available for stem cell donation.
Cardiac shortening fraction greater than or equal to 25%.
Creatinine clearance or glomerular filtration rate (GFR) greater than or equal to 40 ml/min/1.73 m^2.
Forced vital capacity (FVC) greater than or equal to 40% of predicted value or a pulse oximetry value of greater than or equal to 92% on room air.
Direct bilirubin less than or equal to 3 mg/dl.
Age-dependent performance score of greater than or equal to 50.
Serum glutamic pyruvic transaminase (SGPT) less than 3 times the upper limit of normal for age.
Karnofsky or Lansky (age-dependent) performance score of greater than or equal to 50.
No known allergy to murine products or human anti-mouse antibody (HAMA) results within normal limits.
Not pregnant (confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment).
Not breast feeding.
Inclusion criteria (stem cell donor):
Inclusion criteria (transplant recipient - stem cell boost)
Has experienced one of the following disorders post-transplant:
Exclusion: NA
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| Name | Affiliation | Role |
|---|---|---|
| Brandon Triplett, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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There were 73 enrollments at St. Jude Children's Research Hospital between 12/2007 and 12/2013. Of the 73, 37 were non-patient donors who did not receive therapeutic intervention, and therefore, no outcome data was collected.
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| ID | Title | Description |
|---|---|---|
| FG000 | High-Risk Hematologic Malignancies | Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF. |
| 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 | Dec 6, 2016 |
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| Stem cell transplantation | Procedure | An infusion of HLA mismatched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device. |
|
| Fludarabine | Drug | Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies. |
|
|
| Thioplex® | Drug | Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies. |
|
|
| L-phenylalanine mustard | Drug | Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies. |
|
|
| Mycophenolate mofetil | Drug | Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies. |
|
|
| Rituxan™ | Drug | Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies. |
|
|
| Alemtuzumab | Drug | After January 2010, due to the unavailability of muromonab, transplant recipients received a conditioning regimen consisting of systemic chemotherapy and antibodies, including alemtuzumab. |
|
|
| Cyclophosphamide | Drug | Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies. |
|
|
| Anti-thymocyte globulin (Rabbit) | Drug | Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies. |
|
|
| G-CSF | Drug | Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies. |
|
|
| Muromonab | Drug | Prior to January 2010, transplant participants received a conditioning regimen consisting of systemic chemotherapy and antibodies, including muromonab. Muromonab became unavailable from the manufacturer at that time and was replaced by alemtuzumab. |
|
|
| Disease-Free Survival (DFS) | Estimate the one-year disease-free survival (DFS) for research participants who receive this study treatment. DFS is defined as time from transplantation to the occurrence of relapse or death due to relapse. Patients who are alive at the time of analysis or die due to other causes will be censored at the time of their events. The estimated percentage of participants with DFS at one-year post-transplantation is reported using Kaplan-Meier analysis. | One year post-transplant |
| Incidence of Non-hematologic Regimen-related Toxicities | Estimate of the incidence of non-hematologic regimen-related toxicity and regimen-related toxicity in the first 100 days post-transplant. The percentage of participants are reported by maximum grade seen using binomial distribution. Participants were graded for toxicity using Common Terminology Criteria for Adverse Events version 3.0. In general, Grade 1 is mild, 2 is moderate toxicity but generally does not require treatment, 3 is severe enough to require treatment, 4 is life-threatening, and 5 means it was associated with death. | 100 days post-transplant |
| Incidence of Regimen-related Mortality | The incidence of regimen-related mortality in the first 100 days post-transplant is estimated based on binomial distribution. | 100 days post-transplant |
| To Estimate the Cumulative Incidence of Relapse for Research Participants Who Receive This Study Treatment. | The Cumulative Incidence of Relapse will be reported as the proportion of number of relapses since transplant to the total number of patients at risk at five years post-transplant. | five years post-transplant |
| To Estimate the Rate of Overall Grade III-IV Acute GVHD, and the Rate and Severity of Chronic GVHD in Research Participants. | The rate of Overall Grade III-IV Acute AVHD will be report as the proportion of patients who have Grade III-IV Acute GVHD to the total patients with transplant. The rate of Chronic GVHD will be report as the proportion of patients who have Chronic GVHD to the total patients with transplant. The Severity of Chronic GVHD will be reported using CTCAE grading system, as a number. | five years post-transplant |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-Risk Hematologic Malignancies | Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was evaluated at the time of transplantation. | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Age, Customized | Age was evaluated at the time of transplantation. | Median | Full Range | years |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Conditioning Drug Received | Number | 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) | To determine if one year event-free survival can be improved in pediatric patients undergoing a haploidentical transplant by using a reduced intensity conditioning regimen and a targeted dose T cell depleted donor product. EFS is defined as time from transplantation to the occurrence of relapse or death due to any cause. Patients who are alive at the time of analysis will be censored. The estimated percentage of participants with EFS at one-year post-transplantation is reported using Kaplan-Meier analysis. | Posted | Number | Percentage of participants | one year post-transplant |
|
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Estimate the one-year overall survival (OS) for research participants who receive this study treatment. OS is defined as time from transplantation to death due to any cause. Patient who are alive at the time of analysis will be censored. The estimated percentage of participants with OS at one-year post-transplantation is reported using Kaplan-Meier analysis. | Posted | Number | Percentage of participants | one year post-transplant |
|
| ||||||||||||||||||||||||||||
| Secondary | Disease-Free Survival (DFS) | Estimate the one-year disease-free survival (DFS) for research participants who receive this study treatment. DFS is defined as time from transplantation to the occurrence of relapse or death due to relapse. Patients who are alive at the time of analysis or die due to other causes will be censored at the time of their events. The estimated percentage of participants with DFS at one-year post-transplantation is reported using Kaplan-Meier analysis. | Posted | Number | Percentage of participants | One year post-transplant |
|
| ||||||||||||||||||||||||||||
| Secondary | Incidence of Non-hematologic Regimen-related Toxicities | Estimate of the incidence of non-hematologic regimen-related toxicity and regimen-related toxicity in the first 100 days post-transplant. The percentage of participants are reported by maximum grade seen using binomial distribution. Participants were graded for toxicity using Common Terminology Criteria for Adverse Events version 3.0. In general, Grade 1 is mild, 2 is moderate toxicity but generally does not require treatment, 3 is severe enough to require treatment, 4 is life-threatening, and 5 means it was associated with death. | Posted | Number | percentage of participants | 100 days post-transplant |
|
| ||||||||||||||||||||||||||||
| Secondary | Incidence of Regimen-related Mortality | The incidence of regimen-related mortality in the first 100 days post-transplant is estimated based on binomial distribution. | Posted | Number | Percentage of participants | 100 days post-transplant |
|
| ||||||||||||||||||||||||||||
| Secondary | To Estimate the Cumulative Incidence of Relapse for Research Participants Who Receive This Study Treatment. | The Cumulative Incidence of Relapse will be reported as the proportion of number of relapses since transplant to the total number of patients at risk at five years post-transplant. | Posted | Number | Percentage of participants | five years post-transplant |
|
| ||||||||||||||||||||||||||||
| Secondary | To Estimate the Rate of Overall Grade III-IV Acute GVHD, and the Rate and Severity of Chronic GVHD in Research Participants. | The rate of Overall Grade III-IV Acute AVHD will be report as the proportion of patients who have Grade III-IV Acute GVHD to the total patients with transplant. The rate of Chronic GVHD will be report as the proportion of patients who have Chronic GVHD to the total patients with transplant. The Severity of Chronic GVHD will be reported using CTCAE grading system, as a number. | Posted | Number | Percentage of participants | five years post-transplant |
|
|
Adverse events were collected from the date of participant enrollment through December 23, 2015.
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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 | High-Risk Hematologic Malignancies | Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF. | 16 | 31 | 20 | 31 | 30 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction, micafungin | Immune system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Graft failure | Blood and lymphatic system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Post-transplant lymphoproliferative disease | Blood and lymphatic system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Fever without neutropenia | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Headache | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Vomiting (disorder) | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hemorrhage, diffuse alveolar | Vascular disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Failure, hepatic | Hepatobiliary disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Veno-occlusive disease, hepatic | Hepatobiliary disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Adult respiratory distress syndrome (disorder) | Respiratory, thoracic and mediastinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Failure, renal | Renal and urinary disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hemorrhagic cystitis | Renal and urinary disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Fever without neutropenia | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hepatitis | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, acinetobacter baumannii, blood | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, aceinetobacter calcoaceticus, baumannii, blood | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, coagulase negative staphylocuccus, skin | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, enterobacter cloacae, blood culture | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, enterococcus faecalis, blood | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, influenza type A, respiratory tract | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, staphylocuccus epidermidis, blood | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, urinary tract, gamma hemolytic streptococcus | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, vancomycin-resistant enterococcus, blood | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, vancomycin resistant enterococcus, blood/Hickman line | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Nausea (finding) | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Vomiting (disorder) | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Epistaxis | Vascular disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hemorrhagic cystitis | Vascular disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Elevated ALT (SGPT) | Metabolism and nutrition disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Elevated GGT | Metabolism and nutrition disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hypokalemia (disorder) | Metabolism and nutrition disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hypophosphatemia (disorder) | Metabolism and nutrition disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Confusion | Nervous system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hemorrhagic cystitis | Renal and urinary disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Cytokine Release Syndrome (Campath) [10/20 (50%)] | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment | 20 received Campath and were at risk |
|
| Cytokine Release Syndrome (muromonab) [3/11 (27.27%)] | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment | 11 received muromonab and were at risk |
|
| Cytokine Release Syndrome (Stem Cell Infusion) | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Headache | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Pain, generalized, multiple sites | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Fever without neutropenia | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, adenovirus, blood | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, adenovirus, respiratory tract | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, adenovirus, stool | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, BK Virus, bladder | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, BK Virus, blood | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, BK Virus, urine | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, Clostridium Difficile, stool | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, herpes simplex, lip | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, Klebsiella pneumoniae, blood | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection, vancomycin-resistant enterococcus, rectum | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
|
Not provided
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brandon Triplett, MD | St. Jude Children's Research Hospital | 866-278-5833 | referralinfo@stjude.org |
| May 24, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015470 | Leukemia, Myeloid, Acute |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| D006456 | Hemoglobinuria |
| D006457 | Hemoglobinuria, Paroxysmal |
| D006689 | Hodgkin Disease |
| D008223 | Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D013852 | Thiotepa |
| D008558 | Melphalan |
| D009173 | Mycophenolic Acid |
| D000069283 | Rituximab |
| D000074323 | Alemtuzumab |
| D003520 | Cyclophosphamide |
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| D016853 | Muromonab-CD3 |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D010752 | Phosphoramide Mustards |
| D007106 | Immune Sera |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| 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 |
| D001685 | Biological Factors |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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