Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00526 | Registry Identifier | NCI Clinical Trial Registration Program |
Not provided
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The study was halted early due to slow accrual.
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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 a combined T cell depleted (TCD) haploidentical peripheral blood stem cell (PBSC) and unrelated umbilical cord blood transplantation (UCBT) using a total lymphoid irradiation (TLI) based preparative regimen.
Primary objective:
Secondary objectives:
Prior to stem cell infusion, participants will receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, granulocyte colony-stimulating factor (G-CSF), mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions. Cells for infusion are prepared using the CliniMACS System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Given by intravenous infusion as part of the preparative regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Neutrophil Engraftment | Neutrophil engraftment is defined as absolute neutrophil count (ANC) recovery of ≥ 0.5 x 10^9/L (500/mm^3) for three consecutive laboratory values obtained on different days (derived from either donor). Date of engraftment is the date of the first of the three consecutive laboratory values. The number of patients engrafted by day +42 post-transplant is provided. | Until day 42 post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Malignant Relapse | Relapse was evaluated using standard World Health Organization (WHO) criteria for each disease. The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Relapse defined as the recurrence of original disease. Death is the competing risk event. The analysis will be implemented using Statistical Analysis System (SAS) macro (bmacro252-Excel2007\cin). Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced malignant relapse is provided |
Not provided
Inclusion Criteria-Transplant Recipient:
Age less than or equal to 21 years old.
Does not have a suitable matched related/sibling donor (MSD) or volunteer matched unrelated donor (MUD) available in the necessary time for stem cell donation.
Has a suitable partially human leukocyte antigen (HLA)-matched (≥ 3 of 6) family member donor.
Has a partially HLA-matched single umbilical cord blood (UCB) unit (≥ 4 of 6) with adequate cell dose. UCB units must fulfill eligibility as outlined in 21 CFR 1271 and agency guidance.
High-risk hematologic malignancy.
Patient must fulfill pre-transplant evaluation:
Exclusion Criteria - Transplant Recipient:
Inclusion criteria - haploidentical donor
At least single haplotype matched (≥ 3 of 6) family member
At least 18 years of age.
Human immunodeficiency virus (HIV) negative.
Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment (if female).
Not breast feeding.
Regarding eligibility, is identified as either:
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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 |
Not provided
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
Not provided
The 12 enrolled blood donors did not undergo transplantation and are therefore not included in the results reported here.
Twelve participants meeting eligibility criteria and 12 of their blood donors were enrolled at St. Jude Children's Research Hospital between July 2014 and January 2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, granulocyte colony-stimulating factor (G-CSF), mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions. Cells for infusion are prepared using the CliniMACS System. Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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: v. 0.0 - Initial | Feb 26, 2014 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Thiotepa | Drug | Given by intravenous infusion as part of the preparative regimen. |
|
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| Fludarabine | Drug | Given by intravenous infusion as part of the preparative regimen. |
|
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| Melphalan | Drug | Given by intravenous infusion as part of the preparative regimen. |
|
|
| Mesna | Drug | Mesna is generally dosed at approximately 25% of the cyclophosphamide dose. It is generally given intravenously prior to and again at 3, 6 and 9 hours following each dose of cyclophosphamide. |
|
|
| G-CSF | Biological | Given either by intravenous infusion or subcutaneously daily until absolute neutrophil count (ANC) >2000 for 3 consecutive days. |
|
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| Mycophenolate mofetil | Drug | Given either orally or by intravenous infusion as part of the post-transplantation immunosuppression. |
|
|
| Tacrolimus | Drug | Given either orally or by intravenous infusion as part of the post-transplantation immunosuppression. |
|
|
| Methylprednisolone | Drug | Given either intravenously or orally, if needed to treat graft-versus-host-disease (GVHD). |
|
|
| Total lymphoid irradiation | Radiation | TLI will be administered in divided fractions given at a minimum of 6 hours apart. |
|
|
| Lymphocyte infusions | Biological | Donors will undergo haploidentical mobilization with G-CSF. Cells will be collected by leukapheresis over two days, then processed using the investigational CliniMACS device and CD34 Microbead reagent as directed by the manufacturer. |
|
|
| CliniMACS | Device | The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells. |
|
|
| One year after transplantation |
| Number of Participants With Event-free Survival (EFS) | The Kaplan-Meier estimate of EFS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given. Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not experience any events defined above is provided. | One year after transplantation |
| Number of Participants With Overall Survival (OS) | The Kaplan-Meier estimate of OS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) - date of hematopoietic cell transplantation (HCT) and all participants surviving after 1 year post-transplant will be considered as censored. Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not die at 1 year post-transplant is provided. | One year after transplantation |
| Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT | Cumulative incidence of acute GVHD was estimated using Kalbfleisch-Prentice method. Death is the competing risk event. SAS macro (bmacro252-Excel2007\cin) available at St. Jude was used for analysis. Severity of GVHD and stage were determined using the Clinical Oncology Group (COG) Stem Cell Committee Consensus Guidelines for establishing organ stage and overall grade of acute GVHD. Participants are graded on a scale from I to IV, with I being mild and IV being severe. Overall Clinical Grade (based on the highest stage obtained): Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin and no liver or gut involvement. Grade II: Stage 3 skin, or Stage I liver involvement, or Stage 1 gastrointestinal (GI). Grade III: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI. Grade IV: Stage 4 skin, liver or GI involvement. Due to early close of study, a small number of patients were enrolled. The number of patients who experienced acute GVHD is provided. | 100 days after transplantation |
| Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT | Cumulative incidence of acute and chronic GVHD was estimated using Kalbfleisch-Prentice method. Death is competing risk event. SAS macro (bmacro252-Excel2007\cin) available St. Jude was used for such analysis. Severity of chronic GVHD was evaluated using National Institutes of Health (NIH) Consensus Global Severity Scoring. Mild is considered a better outcome with severe being the worst. Criteria for grading chronic GVHD: Mild: 1-2 organs/sites, maximum organ score of 1, and lung score of 1. Moderate: 3 or more organs/sites and maximum organ score of 1 and lung score of 1, OR at least 1 organ/site and maximum organ score of 2 and lung score of 1. Severe: At least 1 organ/site and maximum organ score of 3 and lung score of 2-3. Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced chronic GVHD is provided. | 100 days after transplantation |
| Number of Participants With Secondary Graft Failure | The cumulative incidence of secondary graft failure will be estimated using the Kalbfleisch-Prentice method. Deaths due to toxicity and relapse before day 100 are the competing events. Secondary graft failure or graft rejection will be defined as no evidence of donor chimerism by umbilical cord blood (UCB) and/or haploidentical donor (<10%), or too few cells to perform adequate chimerism analysis, in research participants with prior neutrophil engraftment. Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced secondary graft failure is provided. | 100 days after transplantation |
| Number of Participants With Transplant-related Mortality (TRM) | TRM is any death in remission and related to protocol therapy. The cumulative incidence of TRM was estimated using the Kalbfleisch-Prentice method. Deaths before day 100 because of other reasons are the completing events. Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced TRM is provided. | 100 days after transplantation |
| 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 cumulative incidence of transplant-related morbidity will be estimated using the Kalbfleisch-Prentice method. Deaths before day 100 are the competing risk events. Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced at least one-transplant-related morbidity is provided. | 100 days after transplantation |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions. Cells for infusion are prepared using the CliniMACS System. Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil. |
| 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 |
| |||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | NOS = Not Otherwise Specified | Count of Participants | Participants |
| |||||||||||||||||
| Race/Ethnicity, Customized | NOS = Not Otherwise Specified | Count of Participants | Participants |
| |||||||||||||||||
| Diagnosis | AL = Acute Leukemia; BM = Bone Marrow | Count of Participants | Participants |
| |||||||||||||||||
| Disease Status at HSCT | Complete remission (CR) defined as less than 5 percent leukemia blasts in a bone marrow with evidence of hematopoietic recovery. Relapse is defined as return of 5 percent leukemia blasts or more in a bone marrow after previous achieving CR. Refractory is defined as never achieving CR despite therapy, also known as induction failure. The disease status worsens going down the list with CR1 indicating the best prognosis and Relapse 2 the worst prognosis. | 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 Participants With Neutrophil Engraftment | Neutrophil engraftment is defined as absolute neutrophil count (ANC) recovery of ≥ 0.5 x 10^9/L (500/mm^3) for three consecutive laboratory values obtained on different days (derived from either donor). Date of engraftment is the date of the first of the three consecutive laboratory values. The number of patients engrafted by day +42 post-transplant is provided. | Posted | Count of Participants | Participants | No | Until day 42 post-transplant |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Malignant Relapse | Relapse was evaluated using standard World Health Organization (WHO) criteria for each disease. The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Relapse defined as the recurrence of original disease. Death is the competing risk event. The analysis will be implemented using Statistical Analysis System (SAS) macro (bmacro252-Excel2007\cin). Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced malignant relapse is provided | Posted | Count of Participants | Participants | No | One year after transplantation |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Event-free Survival (EFS) | The Kaplan-Meier estimate of EFS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given. Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not experience any events defined above is provided. | Posted | Count of Participants | Participants | No | One year after transplantation |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Overall Survival (OS) | The Kaplan-Meier estimate of OS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) - date of hematopoietic cell transplantation (HCT) and all participants surviving after 1 year post-transplant will be considered as censored. Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not die at 1 year post-transplant is provided. | Posted | Count of Participants | Participants | No | One year after transplantation |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT | Cumulative incidence of acute GVHD was estimated using Kalbfleisch-Prentice method. Death is the competing risk event. SAS macro (bmacro252-Excel2007\cin) available at St. Jude was used for analysis. Severity of GVHD and stage were determined using the Clinical Oncology Group (COG) Stem Cell Committee Consensus Guidelines for establishing organ stage and overall grade of acute GVHD. Participants are graded on a scale from I to IV, with I being mild and IV being severe. Overall Clinical Grade (based on the highest stage obtained): Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin and no liver or gut involvement. Grade II: Stage 3 skin, or Stage I liver involvement, or Stage 1 gastrointestinal (GI). Grade III: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI. Grade IV: Stage 4 skin, liver or GI involvement. Due to early close of study, a small number of patients were enrolled. The number of patients who experienced acute GVHD is provided. | Posted | Count of Participants | Participants | No | 100 days after transplantation |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT | Cumulative incidence of acute and chronic GVHD was estimated using Kalbfleisch-Prentice method. Death is competing risk event. SAS macro (bmacro252-Excel2007\cin) available St. Jude was used for such analysis. Severity of chronic GVHD was evaluated using National Institutes of Health (NIH) Consensus Global Severity Scoring. Mild is considered a better outcome with severe being the worst. Criteria for grading chronic GVHD: Mild: 1-2 organs/sites, maximum organ score of 1, and lung score of 1. Moderate: 3 or more organs/sites and maximum organ score of 1 and lung score of 1, OR at least 1 organ/site and maximum organ score of 2 and lung score of 1. Severe: At least 1 organ/site and maximum organ score of 3 and lung score of 2-3. Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced chronic GVHD is provided. | Posted | Count of Participants | Participants | No | 100 days after transplantation |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Secondary Graft Failure | The cumulative incidence of secondary graft failure will be estimated using the Kalbfleisch-Prentice method. Deaths due to toxicity and relapse before day 100 are the competing events. Secondary graft failure or graft rejection will be defined as no evidence of donor chimerism by umbilical cord blood (UCB) and/or haploidentical donor (<10%), or too few cells to perform adequate chimerism analysis, in research participants with prior neutrophil engraftment. Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced secondary graft failure is provided. | Posted | Count of Participants | Participants | No | 100 days after transplantation |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Transplant-related Mortality (TRM) | TRM is any death in remission and related to protocol therapy. The cumulative incidence of TRM was estimated using the Kalbfleisch-Prentice method. Deaths before day 100 because of other reasons are the completing events. Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced TRM is provided. | Posted | Count of Participants | Participants | No | 100 days after transplantation |
|
| |||||||||||||||||||||||||||
| Secondary | 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 cumulative incidence of transplant-related morbidity will be estimated using the Kalbfleisch-Prentice method. Deaths before day 100 are the competing risk events. Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced at least one-transplant-related morbidity is provided. | Posted | Count of Participants | Participants | No | 100 days after transplantation |
|
|
Adverse events were collected from participants beginning with the on-study date through one year post-transplantation.
Adverse events were monitored for donors beginning with the on-study date through one year post-transplantation.
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 | Treatment | Interventions: cyclophosphamide, thiotepa, fludarabine, melphalan, mesna, G-CSF, mycophenolate mofetil, tacrolimus, methylprednisolone, total lymphoid irradiation, and lymphocyte infusions. Cells for infusion are prepared using the CliniMACS System. Prior to stem cell infusion, participants receive a preparative regimen of total lymphoid irradiation (TLI), fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare their bone marrow. Thereafter, they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor. Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil. | 6 | 12 | 5 | 12 | 12 | 12 |
| EG001 | Blood Donors | Blood donors were enrolled on the study to provide cells for transplantation used in the Treatment Arm. | 0 | 12 | 0 | 12 | 0 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombotic Thrombocytopenic Purpura | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever without Neutropenia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight Loss | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Enterobacter Cloacae, Blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Fungal and Viral, Pneumonia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Staphylococcus Aureus, Blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonia, Staph Aureus | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Infusion Reaction, Stem Cells | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Allergic Reaction, Platelet Transfusion | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Allergy to Diary Product (Disorder) | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Left Ventricular Cardiac Dysfunction (Disorder) | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight Loss | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rash, Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colitis (Disorder) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypernatremic Dehydration (Disorder) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting (Disorder) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Veno-Occlusive Disease, Hepatic | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cellulitis, Gastrostomy Site | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever without Neutropenia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hepatitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Adenovirus, Respiratory Tract | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Adenovirus, Stool | 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, CMV, Respiratory/Nasopharynx | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Candida Albicans, Oral Mucosa | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Candida Lipolytica, Oral Mucosa | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Clostridium Difficile Colitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Clostridium Difficile, Stool | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Cytomegalovirus, Blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Due to Klebsiella, Bone Marrow Site | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Enterobacter Asburiae, Blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Enterobacter Cloacae, Blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Enterobacter asburiae and Coagulase Negative Staphylococcus, Gastrostomy Wound Site | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Fungal, Liver | 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, Human Herpes Simplex Virus, Oral | 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, Klebsiella pneumoniae, Colon | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Malassezia Furfur, Blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Norovirus, Stool | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Pediococcus Pentosaceua | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Presumed Viral, Oral Mucosa | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Rotavirus, Stool | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection, Staphylococcus Epidermidis, Blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Reactivation, Human Herpes Virus 6, Blood | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoxia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ulceration, Larynx | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Adult Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal Insufficiency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal, Acute Kidney Injury | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Engraftment Syndrome | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain, Abdomen | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain, Neuropathic, Legs and Feet, Bilateral | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
The study was halted early due to slow accrual.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brandon Triplett, MD | St. Jude Children's Research Hospital | 901-595-2766 | brandon.triplett@stjude.org |
| Aug 14, 2017 |
| Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: v. 0.1 | Oct 17, 2014 | Aug 14, 2017 | Prot_SAP_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: v. 1.0 | May 4, 2016 | Aug 14, 2017 | Prot_SAP_002.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: v. 2.0 | Aug 3, 2016 | Aug 14, 2017 | Prot_SAP_003.pdf |
| 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
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D013852 | Thiotepa |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D008558 | Melphalan |
| D015080 | Mesna |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| D009173 | Mycophenolic Acid |
| D016559 | Tacrolimus |
| D008775 | Methylprednisolone |
| D008776 | Methylprednisolone Hemisuccinate |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| 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 |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018942 | Macrolides |
| D007783 | Lactones |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Puerto Rican |
|
| South or Central American |
|
| White |
|
| AL, Lymphoblastic, Pre-T Cell, BM |
|
| AL, Megakaryoblastic, FAB M7, BM |
|
| AL, Monocytic, FAB M5, BM |
|
| AL, Myeloid, Minimal Differentiation, FAB M0, BM |
|
| AL, Myeloid, NOS, BM |
|
| AL, Myeloid, With Maturation, FAB M2, BM |
|
| Lymphoma, Non-Hodgkin's, Anaplastic Large Cell |
|
| CR3 |
|
| Refractory |
|
| Relapse 2 |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
| Participants |
|
|
|
|
|