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| ID | Type | Description | Link |
|---|---|---|---|
| MT2011-05 | Other Identifier | Blood and Bone Marrow Transplant Program |
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This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative haploidentical transplantation for the treatment of high-risk acute myeloid diseases. Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28 patients will be enrolled for a total of 43 patients. Patients will be followed for disease response for 2 years.
A reduced intensity conditioning using Fludara, Cytoxan, and irradiation will start on day -22, followed by infusion of donor NK (natural killer) cells on day-17, 6 doses of interleukin-2 (IL-2) to promote NK expansion (day -17 to day -7), 2 doses of ATG for additional immunosuppression to promote engraftment (day -5 to -4), and infusion of a TCR α/β-depleted same donor graft on day 0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD34 Schema - High-Risk Acute Myeloid Disease | Experimental | Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and filgrastim mobilized CD34+ selected peripheral blood stem cell graft from the same donor. |
|
| TCRα/β Schema - High-Risk Acute Myeloid Disease | Experimental | Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and same donor TCR α/β-depleted cells infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preparative Regimen | Drug | Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant, 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pretransplant, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pretransplant, |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Donor Neutrophil Engraftment | The rate of donor neutrophil engraftment in the absence of leukemia at day +28 will be determined. Successful neutrophil engraftment is defined as an absolute donor-derived neutrophil count of >500 cells/μl. Leukemia free is defined as <5% bone marrow blasts, absence of blasts with Auer rods; absence of extramedullary disease; but cytogenetic or molecular minimal residual disease is allowed. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Disease Free Survival | At 6 Months | |
| Number of Participants With Treatment Related Mortality (TRM) | Cumulative incidence will be used to estimate TRM. | At 6 Months |
Not provided
Inclusion Criteria:
RAEB-1 or RAEB-2 fitting within one of the following disease groups:
Patients with known prior central nervous system (CNS) involvement are eligible provided that it has been treated and CSF is clear for at least 2 weeks prior to enrollment. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the study treatment.
Available related HLA-haploidentical adult donor by at least Class I serologic typing at the A&B locus
Karnofsky score > 50%
Adequate organ function within 28 days of study registration defined as:
Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to NK cell infusion (except for those prescribed as part of the study)
Women of child bearing potential must have a negative pregnancy test within 28 days prior to study registration and agree to use adequate birth control during study treatment
Voluntary written consent
Exclusion Criteria:
Donor Selection:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Miller, M.D. | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| University of Minnesota, Masonic Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | CD34+ Selection Schema : High-Risk Acute Myeloid Disease | Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and filgrastim mobilized CD34+ selected peripheral blood stem cell graft from the same donor. Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on day -6 (0.5 mg/kg) and day -5 (3 mg/kg/day) pre-tx. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
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| NK Cells | Biological | CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pretransplant. |
|
|
| Interleukin-2 | Drug | Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion |
|
|
| CD34 Graft/Anti-thymocyte globulin | Biological | Single donor filgrastim mobilized CD34+ selected peripheral blood stem cell graft (minimum cell dose of 5 x 10^6/kg) on day 0. Rabbit anti-thymocyte globulin (ATG) will be administered on day -1 (0.5 mg/kg) and day +1 and +2 (2.5 mg/kg) pretransplant per institutional guidelines. ATG dosing not identical for all patients. |
|
|
| Donor TCR α/β-depleted Graft/ATG | Biological | Single donor TCR α/β-depleted filgrastim-mobilized peripheral blood stem cells (PBSC) graft (minimum cell dose of 5 x 10^6/kg) on day 0. ATG will be administered on days -6 and -5 (3mg/kg) for most patients. |
|
|
| Number of Participants Who Relapse | Cumulative incidence will be used to estimate relapse. | 2 Years |
| Number of Participants With Early In Vivo Expansion of Natural Killer (NK) Cells | Successful in vivo donor NK cell expansion will be defined by measuring an absolute circulating donor-derived NK cell count of >100 cells/μl in patient's peripheral blood 12 days after infusion. | Day 12 |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| FG001 | TCR α/β Depletion Schema : High-Risk Acute Myeloid Disease | Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor. Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on day -6 (0.5 mg/kg) and day -5(3 mg/kg/day) pre-tx. |
| FG002 | TCR α/β Depletion and ATG at Different Time Schema | PPatients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor. Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered (3 mg/kg/day) pre-tx on different days per institutional guidelines |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | CD34+ Selection Schema : High-Risk Acute Myeloid Disease | Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and filgrastim mobilized CD34+ selected peripheral blood stem cell graft from the same donor. Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on day -6 (0.5 mg/kg) and day -5(3 mg/kg/day) pre-tx. |
| BG001 | TCR α/β Depletion Schema : High-Risk Acute Myeloid Disease | Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor. Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on day -6 (0.5 mg/kg) and day -5(3 mg/kg/day) pre-tx. |
| BG002 | TCR α/β Depletion and ATG at Different Time Schema | Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor. Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered (3 mg/kg/day) pre-tx on different days per institutional guidelines |
| BG003 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | 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 Donor Neutrophil Engraftment | The rate of donor neutrophil engraftment in the absence of leukemia at day +28 will be determined. Successful neutrophil engraftment is defined as an absolute donor-derived neutrophil count of >500 cells/μl. Leukemia free is defined as <5% bone marrow blasts, absence of blasts with Auer rods; absence of extramedullary disease; but cytogenetic or molecular minimal residual disease is allowed. | CD34 Schema - out of 7 patients, 2 patients were NA due to leukemia, 1 died, and 1 was not evaluable so 3 were analyzed (4 were not). TCRα/β Schema - out of 17 patients, 6 patients were NA due to leukemia, 2 were not evaluable. TCRα/β Schema + ATG - 1 patient was given ATG at a different time so their results were reported separately | Posted | Count of Participants | Participants | Day 28 |
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| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Disease Free Survival | CD34 Schema - of 7, 1 patient was not evaluable. TCRα/β Schema - of 17, 15 patients evaluable for DFS , 2 patients were not evaluable. TCRα/β Schema + ATG at different time - 1 patient given ATG at different time so results reported separately | Posted | Count of Participants | Participants | At 6 Months |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Related Mortality (TRM) | Cumulative incidence will be used to estimate TRM. | CD34 Schema - of 7 patients, 1 was not evaluable. TCRα/β Schema - of 17 patients, 8 died of disease, 2 did not have TRM at 6 months, 2 were not evaluable. TCRα/β Schema + ATG at different time - 1 patient given ATG at different time, results reported separately. | Posted | Count of Participants | Participants | At 6 Months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Relapse | Cumulative incidence will be used to estimate relapse. | CD34 Graft - of 7, 1 patient not evaluable, 2 patients did not clear disease, 2 died before 2 years. TCRα/β Schema - of 17, 7 didn't achieve remission, 2 died before 2 years, 2 were not evaluable. TCRα/β Schema + ATG at different time - 1 patient received ATG at different time, results reported separately. | Posted | Count of Participants | Participants | 2 Years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Early In Vivo Expansion of Natural Killer (NK) Cells | Successful in vivo donor NK cell expansion will be defined by measuring an absolute circulating donor-derived NK cell count of >100 cells/μl in patient's peripheral blood 12 days after infusion. | CD34 Graft - of 7, 1 NA due to missing data/tests not performed, 1 not evaluable. TCRα/β Schema - of 17 patients, 15 were evaluable for outcome measure criteria, 2 were not evaluable. TCRα/β Schema + ATG at different time - 1 given ATG at different time, results reported separately. | Posted | Count of Participants | Participants | Day 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-Risk Acute Myeloid Disease | Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and same donor TCR α/β-depleted cells infusion. Data is reported in a combined manner because the AE data was originally reported in the older database as a single arm. Data was separated out for the outcome measures because there was still access to this data externally. At this point, we are unable to separate the individual instance of adverse events by arm because we cannot access the source data. | 19 | 25 | 25 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Coronary Syndrome | Cardiac disorders |
| |||
| Acute Kidney Injury | Renal and urinary disorders |
| |||
| Adult Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders |
| |||
| Atrial Fibrillation | Cardiac disorders |
| |||
| Cytomegalovirus | Infections and infestations |
| |||
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders |
| |||
| Encephalopathy | Nervous system disorders |
| |||
| Fever | General disorders |
| |||
| Graft Failure | General disorders |
| |||
| Heart Failure | Cardiac disorders |
| |||
| Hypocellular Bone Marrow | General disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Maculo-Papular Rash | Skin and subcutaneous tissue disorders |
| |||
| Multi-Organ Failure | General disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Pericardial Effusion | Cardiac disorders |
| |||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Disease Relapse | General disorders |
| |||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders |
| |||
| Retrobulbar Optic Neuritis | Eye disorders |
| |||
| Sepsis | Infections and infestations |
| |||
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders |
| |||
| Acute Coronary Syndrome | Cardiac disorders |
| |||
| Acute Kidney Injury | Renal and urinary disorders |
| |||
| Atrial Fibrillation | Cardiac disorders |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Creatinine Increased | Investigations |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Eye Irritation | Eye disorders |
| |||
| Febrile Neutropenia | Blood and lymphatic system disorders |
| |||
| Epigastric Pain | Gastrointestinal disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Urinary Frequency | Renal and urinary disorders |
| |||
| Lethargy | General disorders |
| |||
| Maculo-Papular Rash | Skin and subcutaneous tissue disorders |
| |||
| Shoulder Pain | Musculoskeletal and connective tissue disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vivid Dreams | Psychiatric disorders |
| |||
| Pustular Folliculitis, Scalp | Skin and subcutaneous tissue disorders |
| |||
| Sinus Tachycardia | Cardiac disorders |
| |||
| Skin Nodules | Skin and subcutaneous tissue disorders |
| |||
| Vomiting - Intermittent | Gastrointestinal disorders |
| |||
| Weight Gain | Investigations |
| |||
| Ankle Sprain | Musculoskeletal and connective tissue disorders |
| |||
| Anorexia | Gastrointestinal disorders |
| |||
| Ascites | Gastrointestinal disorders |
| |||
| Chills | General disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Edema | General disorders |
| |||
| Erythema at Central Venous Catheter Site | General disorders |
| |||
| Eye Infection | Infections and infestations |
| |||
| Facial, Jaw, Parotid Pain | Musculoskeletal and connective tissue disorders |
| |||
| Fever | General disorders |
| |||
| Foot Pain | Musculoskeletal and connective tissue disorders |
| |||
| Gastrointestinal Bleeding | Gastrointestinal disorders |
| |||
| Hemoptysis | Respiratory, thoracic and mediastinal disorders |
| |||
| Hypertension | Vascular disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Infection, NOS | Infections and infestations |
| |||
| Infusion Related Reaction | General disorders |
| |||
| Injection Site Reaction | General disorders |
| |||
| Leg Weakness | Musculoskeletal and connective tissue disorders |
| |||
| Pneumonitis/Pulmonary Infiltrates | Respiratory, thoracic and mediastinal disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Vision Changes, NOS | Eye disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Miller | Masonic Cancer Center, University of Minnesota | 612-626-4024 | mille011@umn.edu |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
Not provided
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| ID | Term |
|---|---|
| C042382 | fludarabine phosphate |
| D003520 | Cyclophosphamide |
| D011827 | Radiation |
| C496971 | IL32 protein, human |
| D007376 | Interleukin-2 |
| 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 |
| D055585 | Physical Phenomena |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| OG002 | TCR α/β Depletion and ATG at Different Time Schema | Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor. Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on different days per institutional guidelines |
|
|
Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor. Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on day -6 (0.5 mg/kg) and day -5(3 mg/kg/day) pre-tx. |
| OG002 | TCR α/β Depletion and ATG at Different Time Schema | Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor. Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on different days per institutional guidelines |
|
|
Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor. Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on day -6 (0.5 mg/kg) and day -5(3 mg/kg/day) pre-tx. |
| OG002 | TCR α/β Depletion and ATG at Different Time Schema | Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor. Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on different days per institutional guidelines |
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| OG001 | TCR α/β Depletion Schema : High-Risk Acute Myeloid Disease | Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and TCR α/β-depleted haploidentical graft from the same donor. Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant (pre-tx), 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pre-tx, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pre-tx NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pre-tx Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on day -6 (0.5 mg/kg) and day -5(3 mg/kg/day) pre-tx. |
| OG002 | TCR α/β Depletion and ATG at Different Time Schema | Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and same donor TCR α/β-depleted cells infusion. Preparative Regimen: Preparative Regimen: 1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant, 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pretransplant, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pretransplant, NK Cells: CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pretransplant. Interleukin-2: Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion Anti-thymocyte globulin: rabbit anti-thymocyte globulin will be administered on different days per institutional guidelines |
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