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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03671 | Registry Identifier | NCI Clinical Trial Registration Program |
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| Name | Class |
|---|---|
| Assisi Foundation | OTHER |
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Recent studies of conventional chemotherapy for infants with high-risk hematologic malignancies show that the long-term disease-free survival is low. Although blood and marrow stem cell transplantation using an HLA identical sibling has improved the outcome for these children, less than 25% have this donor source available. Another option is haploidentical transplantation using a partially matched family member donor (i.e. parental donor).
Although haploidentical transplantation has proven curative for some patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including infection and graft versus host disease (GVHD). Building on prior institutional trials, this study will provide patients a haploidentical graft depleted of T lymphocytes using the investigational device, CliniMACS selection system. One week after the transplant procedure, patients will also receive an infusion of additional donor derived white blood cells called Natural Killer (NK) cells in an effort to decrease risks for rejection of the graft, disease relapse, and regimen related toxicity. The primary objective of the study is to evaluate 1 year survival in infants with high risk hematologic malignancies who receive this study treatment.
Secondary objectives for this study include the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Participants | Experimental | Participants who meet the eligibility criteria for this study. Donor cells will be obtained using the Miltenyi Biotec CliniMACS device. Interventions: Chemotherapy and antibodies, allogeneic stem cell transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy and antibodies | Drug | Study participants will receive a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants will receive an infusion of additional donor derived cells called NK cells. |
| Measure | Description | Time Frame |
|---|---|---|
| One-year Survival | The one-year survival of infants with high-risk hematologic malignancies who receive a haploidentical transplant procedure using a total body irradiation (TBI)-excluding conditioning regimen followed by an HLA-nonidentical family donor hematopoietic stem cell (HSC) graft depleted of T cells ex vivo using the CliniMACS CD34+ selection system, with a subsequent infusion of donor NK cells purified ex vivo using the CliniMACS CD3+ depletion and CD56+ enrichment system. The Kaplan-Meier estimate for one-year survival is reported. | One year after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Transplant-Related Adverse Outcomes: Regimen-Related Mortality | The cumulative incidences of regimen-related mortality will be estimated using method of Kalbfleisch and Prentice. | 100 days post-transplantation |
| Number of Transplant-Related Adverse Outcomes: Engraftment Failure |
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Inclusion Criteria:
Must have one of the following diagnosis:
Inclusion criteria Donor research participants
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Brandon Triplett, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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19 stem cell recipients were enrolled, and 5 were excluded. Two participants did not have natural killer cell infusions due to donor was unable to donate enough CD34+ cells or CD56+ cells for infusion, 1 participant became ineligible because they turned 2 years old prior to start of therapy, 1 withdrew and 1 expired.
19 participants and 21 stem cell donors were enrolled between October 2006 and June 2011. The study was temporarily closed to accrual in June 2011 due to unavailability of study drug. The study was formally closed March 2015 because of continued unavailability of study drug. The 21 donors are excluded from this report.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Participants | Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells. Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Miltenyi Biotec CliniMACS | Device | Stem cell selection device |
|
| Allogeneic stem cell transplantation | Procedure | Allogeneic natural killer (NK)cell infusion |
|
|
Engraftment failure is defined as <10% donor cell chimerism at any time point between 28 and 100 days after transplant with no evidence of disease relapse or requiring stem cell boost. |
| 100 days post-transplantation |
| Number of Transplant-Related Adverse Outcomes: Fatal Acute Graft-Versus Host Disease (GVHD) | The cumulative incidence estimate for occurrence of fatal acute GVHD by the end of the first 100 days post-transplant was calculated using method of Kalbfleisch and Prentice. | 100 days post-transplantation |
| Number of Incidences of Chronic GVHD. | Chronic GVHD was graded according to Seattle Criteria: limited or extensive. Limited is defined as localized skin and/or hepatic dysfunction. Extensive is defined as one or more of the following:
| Up to 5 years after transplant |
| Factors Affecting One-year Survival: Median Age of Donor at HSCT | Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). | Up to one year after transplant |
| Factors Affecting One-year Survival: Median Dose of CD34 | Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). | Up to one year after transplant |
| Factors Affecting One-year Survival: Median Dose of NK Cells | Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). | Up to one year after transplant |
| Factors Affecting One-year Survival: Disease Status at HSCT | Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). | Up to one year after transplant |
| Factors Affecting One-year Survival: Donor Type | Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). | Up to one year after transplant |
| Factors Affecting One-year Survival: Match N/6 HLA Loci | HLA typing determined the degree of match by looking at 6 different HLA loci. The results indicate the number of the 6 loci that matched for each participant. Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). | Up to one year after transplant |
| Factors Affecting One-year Survival: Minimal Residual Disease (MRD) | Detection of leukemia blasts in bone marrow by flow cytometry | Up to one year after transplant |
| Incidence of and Risk Factors for Organ Dysfunction. | The organ dysfunction will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly. | Up to 5 Years after transplant |
| Incidence of and Risk Factors for Long-term Neurocognitive Deficit. | The long-term neurocognitive deficit will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly. | Up to 5 Years after transplant |
| Frequency of and Clinical Relevance of Minimal Residual Disease (MRD) Before and After Transplantation | The presence or absence of MRD before and after the bone marrow transplant (BMT) and its frequency distribution will be obtained for each time point separately. | Baseline before HSCT, 1 year post HSCT, and up to 5 years post HSCT |
| Kinetics of Lymphohematopoietic Reconstitution | The lymphohematopoietic reconstitution will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly. | From 0-3 months after HSCT through 4-5 years after HSCT |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All evaluable participants are included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alive | Group of participants who survived to at least one year post HSCT. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells. Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device. |
| BG001 | Expired | Those participants who did not survive to at least one year post HSCT. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells. Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device. |
| 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 |
| |||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | One-year Survival | The one-year survival of infants with high-risk hematologic malignancies who receive a haploidentical transplant procedure using a total body irradiation (TBI)-excluding conditioning regimen followed by an HLA-nonidentical family donor hematopoietic stem cell (HSC) graft depleted of T cells ex vivo using the CliniMACS CD34+ selection system, with a subsequent infusion of donor NK cells purified ex vivo using the CliniMACS CD3+ depletion and CD56+ enrichment system. The Kaplan-Meier estimate for one-year survival is reported. | Posted | Number | percentage of participants | One year after transplant |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Transplant-Related Adverse Outcomes: Regimen-Related Mortality | The cumulative incidences of regimen-related mortality will be estimated using method of Kalbfleisch and Prentice. | Posted | Number | participants | 100 days post-transplantation |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Transplant-Related Adverse Outcomes: Engraftment Failure | Engraftment failure is defined as <10% donor cell chimerism at any time point between 28 and 100 days after transplant with no evidence of disease relapse or requiring stem cell boost. | Posted | Number | 95% Confidence Interval | proportion of engraftment failures | 100 days post-transplantation |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Transplant-Related Adverse Outcomes: Fatal Acute Graft-Versus Host Disease (GVHD) | The cumulative incidence estimate for occurrence of fatal acute GVHD by the end of the first 100 days post-transplant was calculated using method of Kalbfleisch and Prentice. | Posted | Number | Number of Deaths | 100 days post-transplantation |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Incidences of Chronic GVHD. | Chronic GVHD was graded according to Seattle Criteria: limited or extensive. Limited is defined as localized skin and/or hepatic dysfunction. Extensive is defined as one or more of the following:
| Posted | Count of Participants | Participants | Up to 5 years after transplant |
|
| ||||||||||||||||||||||||||||
| Secondary | Factors Affecting One-year Survival: Median Age of Donor at HSCT | Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). | Posted | Median | Full Range | Years | Up to one year after transplant |
| ||||||||||||||||||||||||||||
| Secondary | Factors Affecting One-year Survival: Median Dose of CD34 | Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). | Posted | Median | Full Range | CD34 X 10^6/kg | Up to one year after transplant |
| ||||||||||||||||||||||||||||
| Secondary | Factors Affecting One-year Survival: Median Dose of NK Cells | Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). | Posted | Median | Full Range | NKcells X 10^6/kg | Up to one year after transplant |
| ||||||||||||||||||||||||||||
| Secondary | Factors Affecting One-year Survival: Disease Status at HSCT | Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). | Posted | Number | participants | Up to one year after transplant |
| |||||||||||||||||||||||||||||
| Secondary | Factors Affecting One-year Survival: Donor Type | Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). | Posted | Number | participants | Up to one year after transplant |
| |||||||||||||||||||||||||||||
| Secondary | Factors Affecting One-year Survival: Match N/6 HLA Loci | HLA typing determined the degree of match by looking at 6 different HLA loci. The results indicate the number of the 6 loci that matched for each participant. Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model). | Posted | Number | participants | Up to one year after transplant |
| |||||||||||||||||||||||||||||
| Secondary | Factors Affecting One-year Survival: Minimal Residual Disease (MRD) | Detection of leukemia blasts in bone marrow by flow cytometry | Only four of the 14 participants had MRD measured at the one-year time point. | Posted | Number | participants | Up to one year after transplant |
| ||||||||||||||||||||||||||||
| Secondary | Incidence of and Risk Factors for Organ Dysfunction. | The organ dysfunction will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly. | There was not enough data available after 1 year post-transplant to evaluate long term outcomes on this study. | Posted | Up to 5 Years after transplant |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of and Risk Factors for Long-term Neurocognitive Deficit. | The long-term neurocognitive deficit will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly. | There was not enough data available after 1 year post-transplant to evaluate long term outcomes on this study. | Posted | Up to 5 Years after transplant |
|
| |||||||||||||||||||||||||||||
| Secondary | Frequency of and Clinical Relevance of Minimal Residual Disease (MRD) Before and After Transplantation | The presence or absence of MRD before and after the bone marrow transplant (BMT) and its frequency distribution will be obtained for each time point separately. | MRD data was collected on only four participants during at least one time point. | Posted | Count of Participants | Participants | No | Baseline before HSCT, 1 year post HSCT, and up to 5 years post HSCT |
|
| ||||||||||||||||||||||||||
| Secondary | Kinetics of Lymphohematopoietic Reconstitution | The lymphohematopoietic reconstitution will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly. | Data was not available for analysis for all patients at all time points. | Posted | Median | Full Range | cells *10^3/µl | From 0-3 months after HSCT through 4-5 years after HSCT |
|
Adverse events are reported from the on-study date through April 2015 (up to one year post-transplant). All 16 patients who were enrolled and proceeded to transplant are included.
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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 | Study Participants | Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells. Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device. | 15 | 16 | 16 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Graft Failure | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment | Bone Marrow Transplantation Complex/Multicomponent Event |
|
| Graft Rejection | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment | Bone Marrow Transplantation Complex/Multicomponent Event |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Post-Transplant Lymphoproliferative Disease | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Cardiac Tamponade | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fever without Neutropenia | General disorders | CTCAE (2.0) | Non-systematic Assessment | Constitutional Symptoms |
|
| Colitis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemorrhage, Brain | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Veno-Occlusive Disease, Hepatic | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fever Without Neutropenia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Aspergillus, Central Nervous System | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Methicillin Resistant Staphylococcus Aureus | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, RSV, Pneumonitis | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Staphylococcus Aureus, Blood | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Staphylococcus Epidermidis, Blood | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Stenotrophomonas, Blood | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Failure, Renal | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Engraftment Syndrome | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Gastrointestinal Perforation | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Drug Reaction, Defibrotide | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Allergic Drug Reaction, OKT3 | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Allergic Drug Reaction, Thiotepa | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Allergic Reaction, Pure Red Blood Cells | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Allergic Reaction, Platelet Transfusion | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash, Generalized | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Prolonged QTc | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Heart block (incomplete right bundle branch block) | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Edema of hand | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Edema, Anasarca | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Edema, Facial | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Edema, Feet | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Edema, Generalized | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Edema, Lower Extremity | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Murmur | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pulmonary Edema | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Coagulopathy, Elevated Bleeding Times | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fever Without Neutrophenia | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Weight Loss | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Abscess, Longissimus Colli, left | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Erythema, Face | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Erythema, Genitourinary | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Erythema, Labia, Perianal Region | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Erythema, Neck | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Erythema, Perianal | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyperpigmentation, Peri-Rectal | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Petechiae, Eyes | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash, Diaper | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash, Face | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash, Generalized | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash, Labia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash, Lower Left Leg | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash, Palms and Feet | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash, Perineum | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash, Scaly, Non-Erythematous | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash, Thorax | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Toxic Epidermal Necrolysis | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemorrhage, Gastrointestinal, Oral | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Loss of Appetite | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Bilateral Subdural hematomas | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Epistaxis | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Gastrointestinal Hemorrhage | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hematemesis | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hematoma, Scalp | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hematuria | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemorrhage, Biopsy Site | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemorrhage, Secretions from Endotracheal Tube, Respiratory Tract | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemorrhage, Vasocath Site | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Petechiae, Lower Extremity | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Failure, Hepatic | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Splenomegaly | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Veno-Occlusive Disease, Hepatic | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fever Without Neutropenia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection With Neutropenia, Klebsiella and Escherichia Coli, Blood | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection Without Neutropenia, Enterococcus Faecalis, Blood | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection With Neutropenia, Gamma Hemolytic Streptococcus, Skin | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Adenovirus, Stool | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Aspergillus Terreus, Lungs | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Aspergillus, Retina | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Candida, Diaper Area with Rash | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Candidiasis, Mouth | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Coagulase Negative Staph, Blood | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Coagulase Negative Staphylococcus, Wrist | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Influenza Virus A | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Klebsiella Pneumoniae, Hickman Line | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Legionella, Mucous | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Pantoea Species, Blood | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Parainfluenza Virus 3 | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Pseudomonas Aeruginosa, Blood | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Staphylococcus Aureus, Skin | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Stomatococcus Mucilaginosus, Blood | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Stool, Vancomycin Resistant Enterococci | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection, Streptococcus Mitis, Hickman Line | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Splenic Infarction | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Meningoencephalitis | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Mood Alteration - Anxiety/Agitation | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Exposure Keratitis | Eye disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Glaucoma, Right Eye | Eye disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyphema, Right Eye | Eye disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain, Abdominal | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain, Generalized, Multiple Sites | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain, Gums | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain, Throat | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemorrhage, Pulmonary | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nodule, Pulmonary | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pulmonary Airspace Disease, Diffuse, Bilateral | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Tachypnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Renal Disease | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Capillary Leak Syndrome | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Engraftment Syndrome | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Abdominal Compartment Syndrome | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Systemic Inflammatory Response Syndrome | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Cytokine Release Syndrome, Rituximab | General disorders | CTCAE (2.0) | Non-systematic Assessment |
|
The study was limited due to the unavailability of the study drug OKT3 beginning in June 2011. The study was temporarily closed to accrual. Because OKT3 is still unavailable, the study was formally closed to accrual in March 2015.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brandon Triplett, MD | St. Jude Children's Research Hospital | 866-278-5833 | referralinfo@stjude.org |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D015614 | Histiocytosis |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D000906 | Antibodies |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D013852 | Thiotepa |
| D008558 | Melphalan |
| D016853 | Muromonab-CD3 |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| 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 |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
Not provided
Not provided
| Male |
|
| Other |
|
| White |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Study participants as previously described.
| OG005 | 2-3 Years After HSCT | Study participants as previously described. |
| OG006 | 3-4 Years After HSCT | Study participants as previously described. |
| OG007 | 4-5 Years After HSCT | Study participants as previously described. |
|
|
| Positive MRD |
|
| Data Not Collected |
|
| Positive MRD |
|
| Data Not Collected |
|
| Positive MRD |
|
| Data Not Collected |
|
|
|
|
|
|
|
|