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The purpose of this study is to compare safety and efficacy of reduced-intensity conditioning and myeloablative conditioning regimens prior to HSCT in high-risk AML/MDS pediatric and young adult patients. This study investigates the use of two novel conditioning therapies for hematopoietic stem cell transplant (HSCT). The primary focus of both the investigators' myeloablative and reduced-intensity conditioning regimens is to reduce overall toxicity so that pediatric and young adult patients with high-risk AML/MDS with significant pretransplant comorbidities who would have been ineligible to proceed to HSCT previously can now receive potentially life-saving treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced-Intensity Conditioning | Active Comparator | Campath (alemtuzumab), Droxia (hydroxyurea), Fludara (fludarabine), Alkeran (melphalan), Thiotepa (triethylenethiophosphoramide) Trade Name (generic name) |
|
| Myeloablative Conditioning | Active Comparator | Campath (alemtuzumab), Thiotepa (triethylenethiophosphoramide) , Fludara (fludarabine), Busulfex (busulfan) Trade Name (generic name) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced-Intensity Conditioning Regimen | Drug | Campath (alemtuzumab) - drug class: monoclonal antibody Droxia (hydroxyurea) - drug class: antimetabolite Fludara (fludarabine) - drug class: antimetabolite Alkeran (melphalan) - drug class: alkylating agent Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Non-relapsed Deaths by 100 Days Post-transplant in Pediatric Patients Receiving a Myeloablative or Reduced-intensity Preparative Regimen Prior to HSCT for High-risk AML and MDS. | Number of non-relapsed deaths that occur | Day 100 |
| Preliminary Efficacy (Event-free Survival at 6 Months) in Pediatric Patients Receiving a Myeloablative or Reduced-intensity Preparative Regimen Prior to HSCT for High-risk AML and MDS. | Event-free survival at 6 months, where events are defined as relapse or death | 6 months |
| Number of Non-relapsed Deaths by 6 Months Post-transplant in Pediatric Patients Receiving a Myeloablative or Reduced-intensity Preparative Regimen Prior to HSCT for High-risk AML and MDS. | Number of non-relapsed deaths that occur | Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| The Pace of Neutrophil Recovery | Neutrophil Engraftment (the first of three consecutive days in which the absolute neutrophil count (ANC) exceeded 500/mcL) | Day of transplant to end of study (Day 365) |
| The Pace of Platelet Recovery |
Not provided
INCLUSION CRITERIA:
Individuals must meet all the following criteria to be eligible for this study.
Pre-transplant organ function criteria for Myeloablative Conditioning regimen:
OR
Pre-transplant organ function criteria for Reduced-Intensity Conditioning regimen:
Renal: creatinine clearance or radioisotope GFR ≥70 mL/min/1.73 m2.
Hepatic: total bilirubin ≤2.5 mg/dL unless the increase in bilirubin is attributable to Gilbert's syndrome; and SGOT (AST), SGPT (ALT), and Alkaline Phosphatase <5 x upper limit of normal (ULN) for age.
Cardiac: normal cardiac function by echocardiogram or radionuclide scan, as defined by left ventricular ejection fraction at rest >40% or shortening fraction >26%.
Pulmonary: FEV1, FVC, and DLCO (corrected for hemoglobin) ≥40% of predicted; if unable to perform pulmonary function tests, then oxygen saturation ≥92% on room air.
EXCLUSION CRITERIA:
Individuals who meet any of the following criteria are not eligible for this protocol.
Additional Exclusion Criteria for Myeloablative Conditioning (MAC) Only Individuals who meet any of the following criteria are not eligible for the MAC regimen.
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| Name | Affiliation | Role |
|---|---|---|
| Randy Windreich, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7581076 | Background | Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995 Jun;15(6):825-8. | |
| 25529383 | Background | Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reduced-Intensity Conditioning | Conditioning Arm nonrandomly assigned based on eligibility (inclusion/exclusion) criteria. Campath (alemtuzumab), Droxia (hydroxyurea), Fludara (fludarabine), Alkeran (melphalan), Thiotepa (triethylenethiophosphoramide) Trade Name (generic name) Reduced-Intensity Conditioning Regimen: Campath (alemtuzumab) - drug class: monoclonal antibody Droxia (hydroxyurea) - drug class: antimetabolite Fludara (fludarabine) - drug class: antimetabolite Alkeran (melphalan) - drug class: alkylating agent Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent |
| 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 3, 2020 |
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|
|
| Myeloablative Conditioning Regimen | Drug | Campath (alemtuzumab) - drug class: monoclonal antibody Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent Fludara (fludarabine) - drug class: antimetabolite Busulfex (busulfan) - drug class: alkylating agent |
|
|
Platelet Engraftment (the first of three consecutive days in which the platelet count exceeded 20,000/mm3 without platelet transfusions for the preceding 7 days)
| Day of transplant to end of study (Day 365) |
| Number of Participants Developing Acute Graft Versus Host Disease (aGVHD) by Grade | Grade 0: no stage 1-4 of any organ. Grade I: stage 1-2 skin rash (stage 1: <25%, stage 2: 25-50% body surface area affected by maculopapular rash), no gut or liver involvement. Grade II: stage 3 skin rash (>50% body surface area affected), or stage 1 GI involvement (10-19.9 mL/kg/day volume of diarrhea), or stage 1 liver involvement (2-3 mg/dL total bilirubin level). Grade III: stage 0-3 skin rash with stage 2-4 GI involvement (stage 2: 20-30 mL/kg/day, stage 3: >30 mL/kg/day volume of diarrhea, stage 4: severe abdominal pain with or without ileus and/or grossly blood stool) or stage 2-3 liver involvement (stage 2: 3-6 mg/dL, stage 3: 6-15 mg/dL total bilirubin level). Grade IV: stage 4 skin rash (generalized erythroderma with bullous formation) or stage 4 liver involvement (>15 mg/dL total bilirubin level). | Day of transplant to end of study (Day 365) |
| Number of Participants Developing Chronic Graft Versus Host Disease (cGVHD) by Grade | Limited cGVHD: localized skin involvement and/or hepatic dysfunction due to cGVHD. Extensive cGVHD: one or more of the following: generalized skin involvement; liver histology showing chronic aggressive hepatitis, bridging necrosis, or cirrhosis; involvement of eye, minor salivary glands or oral mucosa based on biopsy, or any other target organ. Mild cGVHD: 1 or 2 organs involved with no more than score 1 plus lung score 0. Moderate cGVHD: 3 or more organs involved with no more than score 1, or at least one organ (not lung) with score 2, or lung score 1. Severe cGVHD: at least one organ with score 3, or lung score 2 or 3. | Day of transplant to end of study (Day 365) |
| Disease-free Survival (DFS) | The number of subjects who are alive without relapse/leukemia | Day 100 and 180 post-transplant |
| Treatment-related Mortality (TRM) | The number of subjects deceased due to transplant-related (i.e. non-relapse) causes | Day 100 and 180 post-transplant |
| The Number of Subjects With Overall Survival (OS) | The number of subjects who are alive | Day 100 and 180 post-transplant |
| Day 0 Campath (Alemtuzumab) Level | Campath (Alemtuzumab) level measured on the day of transplant | Day 0 |
| Pace of Immune Reconstitution | Immune recovery as measured by lymphocyte subsets | Day 180 |
| Incidence of Primary Graft Failure. | The failure to achieve an ANC ≥500/μL after 42 days, determined by three consecutive measurements on different days, and not caused by recurrent leukemia. | Post-transplant to 42 days post-transplant |
| Incidence of Grades 4 and 5 Adverse Events | Adverse events as assessed by CTCAE | Day 180 |
| FG001 | Myeloablative Conditioning | Conditioning Arm nonrandomly assigned based on eligibility (inclusion/exclusion) criteria. Campath (alemtuzumab), Thiotepa (triethylenethiophosphoramide) ,Fludara (fludarabine), Busulfex (busulfan) Trade Name (generic name) Myeloablative Conditioning Regimen: Campath (alemtuzumab) - drug class: monoclonal antibody Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent Fludara (fludarabine) - drug class: antimetabolite Busulfex (busulfan) - drug class: alkylating agent |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reduced-Intensity Conditioning | Campath (alemtuzumab), Droxia (hydroxyurea), Fludara (fludarabine), Alkeran (melphalan), Thiotepa (triethylenethiophosphoramide) Trade Name (generic name) Reduced-Intensity Conditioning Regimen: Campath (alemtuzumab) - drug class: monoclonal antibody Droxia (hydroxyurea) - drug class: antimetabolite Fludara (fludarabine) - drug class: antimetabolite Alkeran (melphalan) - drug class: alkylating agent Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent |
| BG001 | Myeloablative Conditioning | Campath (alemtuzumab), Thiotepa (triethylenethiophosphoramide) , Fludara (fludarabine), Busulfex (busulfan) Trade Name (generic name) Myeloablative Conditioning Regimen: Campath (alemtuzumab) - drug class: monoclonal antibody Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent Fludara (fludarabine) - drug class: antimetabolite Busulfex (busulfan) - drug class: alkylating agent |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Stem Cell Source | Count of Participants | Participants |
| ||||||||||||||||
| Donor Source | 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 | Number of Non-relapsed Deaths by 100 Days Post-transplant in Pediatric Patients Receiving a Myeloablative or Reduced-intensity Preparative Regimen Prior to HSCT for High-risk AML and MDS. | Number of non-relapsed deaths that occur | Posted | Count of Participants | Participants | Day 100 |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Preliminary Efficacy (Event-free Survival at 6 Months) in Pediatric Patients Receiving a Myeloablative or Reduced-intensity Preparative Regimen Prior to HSCT for High-risk AML and MDS. | Event-free survival at 6 months, where events are defined as relapse or death | Posted | Count of Participants | Participants | 6 months |
| ||||||||||||||||||||||||||||||||
| Primary | Number of Non-relapsed Deaths by 6 Months Post-transplant in Pediatric Patients Receiving a Myeloablative or Reduced-intensity Preparative Regimen Prior to HSCT for High-risk AML and MDS. | Number of non-relapsed deaths that occur | Analysis population includes only subjects without relapse (i.e. subjects who relapse are therefore excluded from this analysis). | Posted | Count of Participants | Participants | Day 180 |
| |||||||||||||||||||||||||||||||
| Secondary | The Pace of Neutrophil Recovery | Neutrophil Engraftment (the first of three consecutive days in which the absolute neutrophil count (ANC) exceeded 500/mcL) | Posted | Median | Full Range | Days | Day of transplant to end of study (Day 365) |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Pace of Platelet Recovery | Platelet Engraftment (the first of three consecutive days in which the platelet count exceeded 20,000/mm3 without platelet transfusions for the preceding 7 days) | Posted | Median | Full Range | days | Day of transplant to end of study (Day 365) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Developing Acute Graft Versus Host Disease (aGVHD) by Grade | Grade 0: no stage 1-4 of any organ. Grade I: stage 1-2 skin rash (stage 1: <25%, stage 2: 25-50% body surface area affected by maculopapular rash), no gut or liver involvement. Grade II: stage 3 skin rash (>50% body surface area affected), or stage 1 GI involvement (10-19.9 mL/kg/day volume of diarrhea), or stage 1 liver involvement (2-3 mg/dL total bilirubin level). Grade III: stage 0-3 skin rash with stage 2-4 GI involvement (stage 2: 20-30 mL/kg/day, stage 3: >30 mL/kg/day volume of diarrhea, stage 4: severe abdominal pain with or without ileus and/or grossly blood stool) or stage 2-3 liver involvement (stage 2: 3-6 mg/dL, stage 3: 6-15 mg/dL total bilirubin level). Grade IV: stage 4 skin rash (generalized erythroderma with bullous formation) or stage 4 liver involvement (>15 mg/dL total bilirubin level). | Subjects must survive at least until 100 days post-transplant for evaluation for acute graft-versus-host disease, i.e. subjects who die before 100 days post-transplant are not evaluable and therefore excluded from analysis. | Posted | Count of Participants | Participants | Day of transplant to end of study (Day 365) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Developing Chronic Graft Versus Host Disease (cGVHD) by Grade | Limited cGVHD: localized skin involvement and/or hepatic dysfunction due to cGVHD. Extensive cGVHD: one or more of the following: generalized skin involvement; liver histology showing chronic aggressive hepatitis, bridging necrosis, or cirrhosis; involvement of eye, minor salivary glands or oral mucosa based on biopsy, or any other target organ. Mild cGVHD: 1 or 2 organs involved with no more than score 1 plus lung score 0. Moderate cGVHD: 3 or more organs involved with no more than score 1, or at least one organ (not lung) with score 2, or lung score 1. Severe cGVHD: at least one organ with score 3, or lung score 2 or 3. | Subjects must survive at least until 365 days post-transplant for evaluation for chronic graft-versus-host disease, i.e. subjects who die before 365 days post-transplant are not evaluable and therefore excluded from analysis. | Posted | Count of Participants | Participants | Day of transplant to end of study (Day 365) |
| |||||||||||||||||||||||||||||||
| Secondary | Disease-free Survival (DFS) | The number of subjects who are alive without relapse/leukemia | Posted | Count of Participants | Participants | Day 100 and 180 post-transplant |
|
| |||||||||||||||||||||||||||||||
| Secondary | Treatment-related Mortality (TRM) | The number of subjects deceased due to transplant-related (i.e. non-relapse) causes | Subjects who die due to transplant-related causes by 100 and 180 days post-transplant, thus subjects who relapse before that time are excluded from analysis. | Posted | Count of Participants | Participants | Day 100 and 180 post-transplant |
| |||||||||||||||||||||||||||||||
| Secondary | The Number of Subjects With Overall Survival (OS) | The number of subjects who are alive | Posted | Count of Participants | Participants | Day 100 and 180 post-transplant |
|
| |||||||||||||||||||||||||||||||
| Secondary | Day 0 Campath (Alemtuzumab) Level | Campath (Alemtuzumab) level measured on the day of transplant | Only 2 subjects in Reduced-Intensity Conditioning arm and no subjects in Myeloablative Conditioning arm had a Day 0 Campath (Alemtuzumab) level drawn. | Posted | Median | Full Range | mcg/mL | Day 0 |
| ||||||||||||||||||||||||||||||
| Secondary | Pace of Immune Reconstitution | Immune recovery as measured by lymphocyte subsets | One subject in each arm did not survive to Day 180 | Posted | Median | Full Range | cells/mm3 | Day 180 |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of Primary Graft Failure. | The failure to achieve an ANC ≥500/μL after 42 days, determined by three consecutive measurements on different days, and not caused by recurrent leukemia. | Posted | Count of Participants | Participants | Post-transplant to 42 days post-transplant |
|
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of Grades 4 and 5 Adverse Events | Adverse events as assessed by CTCAE | Posted | Count of Participants | Participants | Day 180 |
|
|
Day 180
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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 | Reduced-Intensity Conditioning | Campath (alemtuzumab), Droxia (hydroxyurea), Fludara (fludarabine), Alkeran (melphalan), Thiotepa (triethylenethiophosphoramide) Trade Name (generic name) Reduced-Intensity Conditioning Regimen: Campath (alemtuzumab) - drug class: monoclonal antibody Droxia (hydroxyurea) - drug class: antimetabolite Fludara (fludarabine) - drug class: antimetabolite Alkeran (melphalan) - drug class: alkylating agent Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent | 1 | 6 | 6 | 6 | 0 | 6 |
| EG001 | Myeloablative Conditioning | Campath (alemtuzumab), Thiotepa (triethylenethiophosphoramide) ,Fludara (fludarabine), Busulfex (busulfan) Trade Name (generic name) Myeloablative Conditioning Regimen: Campath (alemtuzumab) - drug class: monoclonal antibody Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent Fludara (fludarabine) - drug class: antimetabolite Busulfex (busulfan) - drug class: alkylating agent | 1 | 15 | 15 | 15 | 0 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Sinusoidal obstruction syndromw | Hepatobiliary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Viremia | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment | Pneumonia |
|
| Upper respiratory infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment | Leukopenia |
|
| Platelet count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment | Thrombocytopenia |
|
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment | Lymphopenia |
|
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment | Neutropenia |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment | Low hemoglobin level |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment | Elevated blood glucose level |
|
| Alkaline phosphatase increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| GGT increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Encephalitis infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Randy Windreich | UPMC Children's Hospital of Pittsburgh | 412-692-5055 | randy.windreich@chp.edu |
| Apr 9, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| D006918 | Hydroxyurea |
| C042382 | fludarabine phosphate |
| D008558 | Melphalan |
| D013852 | Thiotepa |
| D002066 | Busulfan |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| 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 |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
Not provided
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Puerto Rico |
|
| Myelodysplastic syndrome (MDS) |
|
| Peripheral Blood |
|
| Umbilical Cord Blood |
|
| Unrelated donor |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
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| Participants |
|
|
| Participants |
|
|
| OG001 | Myeloablative Conditioning | Campath (alemtuzumab), Thiotepa (triethylenethiophosphoramide) ,Fludara (fludarabine), Busulfex (busulfan) Trade Name (generic name) Myeloablative Conditioning Regimen: Campath (alemtuzumab) - drug class: monoclonal antibody Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent Fludara (fludarabine) - drug class: antimetabolite Busulfex (busulfan) - drug class: alkylating agent |
|
|
| Myeloablative Conditioning |
Campath (alemtuzumab), Thiotepa (triethylenethiophosphoramide) ,Fludara (fludarabine), Busulfex (busulfan) Trade Name (generic name) Myeloablative Conditioning Regimen: Campath (alemtuzumab) - drug class: monoclonal antibody Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent Fludara (fludarabine) - drug class: antimetabolite Busulfex (busulfan) - drug class: alkylating agent |
|
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| Participants |
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| Counts |
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| Participants |
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