Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03700 | Registry Identifier | NCI Clinical Trial Registration Program |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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| Name | Class |
|---|---|
| The Hartwell Foundation | OTHER |
| Assisi Foundation | OTHER |
Not provided
Not provided
Not provided
In this study, participants with high-risk hematologic malignancies undergoing hematopoietic cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA)-matched related/sibling donor (MSD), matched unrelated donor (MURD) or killer-immunoglobulin receptors (KIR) ligand mismatched haploidentical donor identified, will receive an umbilical cord blood transplantation (UCBT) using a myeloablative preparative regimen.
The preparative regimen includes fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (10.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1.
The primary objectives is to estimate the event-free survival (EFS) at one-year post-transplant for research participants with high-risk hematologic malignancies undergoing hematopoietic cell transplantation (HCT) using single unit umbilical cord blood (UCB).
Secondary objectives are:
Exploratory Objectives are:
Not provided
Not provided
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Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Research Arm | Other | Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit. Intervention: Preparative Regimen |
|
| Observation Arm | Other | Patients requiring two UCB units will be eligible for UCBT01 on the observational arm. Intervention: Preparative Regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preparative Regimen | Drug | Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1. |
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival (EFS) for Research Participants | Estimate EFS for research participants at one-year post transplant by using single unit umbilical cord blood. The event is defined as relapse, graft failure, death due to any cause. The number of participants who did not experience any of those events (relapse, graft failure, death due to any cause) at year 1 post-transplant was given. | 1 year post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Observational Arm Participants Engrafted | For patients enrolled in the observational arm (undergoing a double unit UCBT), the number of patients engrafted was given. | 1 year |
| Number of Observational Arm Patients Who Relapsed |
Not provided
Inclusion Criteria:
Patient must fulfill pre-transplant evaluation:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amr Qudeimat, 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 |
Not provided
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
Not provided
Not provided
Fourteen patients were enrolled at St. Jude Children's Research Hospital between September 2011 and April 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Research Arm | Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit. Intervention: Preparative Regimen Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The number of observational arm patients who relapsed was given.
| 1 year |
| Number of Deaths of Observational Arm Patients | The number of observational arm patients who died was given. | 1 year |
| Number of Observational Arm Patients With Transplant-related Mortality (TRM) | The number of patients with TRM within the first 100 days post transplant was given. | First 100 days |
| Number of Participants With Acute GVHD | The number of participants with incidence of acute GVHD by grade was given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe. | 1 year |
| Number of Participants With Chronic GVHD | Due to the small sample size, cumulative incidence analysis was not done. The incidence of chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of patients with incidence of chronic GVHD by severity was provided. | 1 year |
| Time to Engraftment of Research Arm Participants | Platelet engraftment was defined as platelet count ≥20,000/mm^3 for 3 consecutive tests performed on different days with no platelet transfusions in the preceding 7 days. Neutrophil engraftment will be defined as achieving ANC ≥ 500/mm3 for 3 consecutive tests performed on different days with evidence of donor cell engraftment. Descriptive statistics are provided. | first 100 days post transplant |
| Incidence of Transplant-related Mortality (TRM) | TRM is death occurring in patients in continuous complete remission. The numbers of patients with TRM was given. | first 100 days post transplant |
| The Number of Participants With Transplant-related Morbidity | Any patient who had adverse events listed either as probable or definite in the first 100 days post-transplant are counted as transplant related morbidity. The number of patients with transplant-related morbidity was given. | first 100 days post transplant |
| FG001 | Observational Arm | Patients requiring two UCB units will be eligible for UCBT01 on the observational arm. Intervention: Preparative Regimen Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Research Arm | Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit. Intervention: Preparative Regimen Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1. |
| BG001 | Observational Arm | Patients requiring two UCB units will be eligible for UCBT01 on the observational arm. Intervention: Preparative Regimen Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1. |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event Free Survival (EFS) for Research Participants | Estimate EFS for research participants at one-year post transplant by using single unit umbilical cord blood. The event is defined as relapse, graft failure, death due to any cause. The number of participants who did not experience any of those events (relapse, graft failure, death due to any cause) at year 1 post-transplant was given. | Posted | Count of Participants | Participants | 1 year post-transplant |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Observational Arm Participants Engrafted | For patients enrolled in the observational arm (undergoing a double unit UCBT), the number of patients engrafted was given. | Posted | Count of Participants | Participants | 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Observational Arm Patients Who Relapsed | The number of observational arm patients who relapsed was given. | Posted | Count of Participants | Participants | 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Deaths of Observational Arm Patients | The number of observational arm patients who died was given. | Posted | Count of Participants | Participants | 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Observational Arm Patients With Transplant-related Mortality (TRM) | The number of patients with TRM within the first 100 days post transplant was given. | Posted | Count of Participants | Participants | First 100 days |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Acute GVHD | The number of participants with incidence of acute GVHD by grade was given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe. | Posted | Count of Participants | Participants | 1 year |
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Chronic GVHD | Due to the small sample size, cumulative incidence analysis was not done. The incidence of chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of patients with incidence of chronic GVHD by severity was provided. | Posted | Count of Participants | Participants | 1 year |
| |||||||||||||||||||||||||||||
| Secondary | Time to Engraftment of Research Arm Participants | Platelet engraftment was defined as platelet count ≥20,000/mm^3 for 3 consecutive tests performed on different days with no platelet transfusions in the preceding 7 days. Neutrophil engraftment will be defined as achieving ANC ≥ 500/mm3 for 3 consecutive tests performed on different days with evidence of donor cell engraftment. Descriptive statistics are provided. | Those patients who did not reach engraftment are not included in the results provided below. | Posted | Mean | Standard Deviation | Days | first 100 days post transplant |
| |||||||||||||||||||||||||||
| Secondary | Incidence of Transplant-related Mortality (TRM) | TRM is death occurring in patients in continuous complete remission. The numbers of patients with TRM was given. | Posted | Count of Participants | Participants | first 100 days post transplant |
| |||||||||||||||||||||||||||||
| Secondary | The Number of Participants With Transplant-related Morbidity | Any patient who had adverse events listed either as probable or definite in the first 100 days post-transplant are counted as transplant related morbidity. The number of patients with transplant-related morbidity was given. | Posted | Count of Participants | Participants | first 100 days post transplant |
|
Adverse events were collected throughout from the start of initiation of conditioning to one year post transplant.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Research Arm | Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit. Intervention: Preparative Regimen Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1. | 4 | 9 | 7 | 9 | 9 | 9 |
| EG001 | Observation Arm | Patients requiring two UCB units will be eligible for UCBT01 on the observational arm. Intervention: Preparative Regimen Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1. | 2 | 4 | 3 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia, Hemolytic | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Effusion, Pericardial | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pericardial effusion (disorder) | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever without neutropenia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration (disorder | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, coagulase negative staph, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, enterococcus faecalis, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, escherichia coli, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, escherichia coli, urine | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperkalemia (disorder) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Acute respiratory distress (finding) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Left pneumothorax (disorder) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Right pneumothorax (disorder) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Effusion, pericardial | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal insufficiency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome (PRES) | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia, hemolytic | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema, generalized | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema, lower extremity | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Febrile neutropenia (disorder) | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever without neutropenia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastritis (disorder) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis, oral mucosa | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| vomiting (disorder) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever without neutropenia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Veno-occlusive disease, hepatic | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Acute infusion reaction, acetaminophen | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Acute infusion reaction, stem cells | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Engraftment syndrome | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Adenoviral enteritis (disorder) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| CMV reactivation | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Enteritis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, adenovirus, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, adenovirus, stool | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, aspergillus, lung | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, BK virus, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, BK virus, urine | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, clostridium difficile, stool | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, enterococcus faecium, vancomycin resistant, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, enterococcus faecium, vancomycin resistant, bronchus | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, enterococcus faecium, vancomycin resistant, penis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, enterocuccus faecium, vancomycin resistant, urine | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, gram positive cocci | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, human herpes virus 6 | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, human herpes virus 6, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, human herpes virus 6, cerebrospinal fluid | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, influenza B, nasal | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, rotavirus, stool | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, staphylococcus, urine | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, streptococcus viridans, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Tinea capitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, adenovirus, nasal | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, candida albicans | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, enterobacter cloacae complex, Hickman Line | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, enterobacter cloacae, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, herpes simplex virus, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, herpes simplex virus, oral mucosa | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, herpes simplex, lip | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, klebsiella oxytoca, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, klebsiella pneumoniae, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, pseudomonas aeruginosa, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, pseudomonas aeruginosa, rectum | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, pseudomonas, tracheal aspirate | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, sinusitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, staphylococcus aureus, blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, staphylococcus aureus, Hickman Line | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, staphylococcus, coagulase positive | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, stenotrophomonas maltophilia, CVAD | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, vancomycin resistant enterococcus | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, vancomycin resistant enterococcus faecium, stool | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, vancomycin resistant enterococcus, rectum | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Respiratory syncytial virus (RSV) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypocalcemia (disorder) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypomagnesemia (disorder) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Demyelination (morphologic abnormality) | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neuropathy, motor | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Syndenham's chorea | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mood alteration-anxiety/agitation | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Severe depression (disorder) | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cystitis, hemorrhagic | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Failure, renal | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal insufficiency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bronchiolitis obliterans organizing pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infiltrates, pulmonary | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lesion of lung (finding) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pleural effusion, left | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonia, middle lobe, right | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pulmonary nodules, consistent with fungal disease | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rash, generalized | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amr Qudeimat, MD | St. Jude Children's Research Hospital | 901-595-8342 | amr.qudeimat@stjude.org |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| Male |
|
| NOS Spanish, Hispanic, latino |
|
| Non Spanish speaking, Non Hispanic |
|
| Puerto Rican |
|
| Declined to respond |
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| Units | Counts |
|---|---|
| Participants |
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