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| ID | Type | Description | Link |
|---|---|---|---|
| MT2005-18 | Other Identifier | Blood and Bone Marrow Transplantation Program | |
| 0509M73449 | Other Identifier | IRB, University of Minnesota |
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Competing study was started.
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RATIONALE: Giving chemotherapy, natural killer cells, aldesleukin, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal cells and cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, mycophenolate mofetil, and methylprednisolone before and after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by donor umbilical cord blood natural killer cells, aldesleukin, and umbilical cord blood transplant works in treating patients with refractory hematologic cancer or other diseases.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a single arm, nonrandomized, open-label study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated Patients | Experimental | All patients receiving treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aldesleukin | Biological | 10 Million units subcutaneous every other day on days -13 (after Natural killer cell graft), -11, -9, -7, -5, -3) If < 45 kilograms (Kg) - interleukin (IL)-2 at 5 MU/m2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months | Number of patients who were alive and free of disease (malignancy) at 6 months after transplant. | 6 Months Post Transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months | Number of patients who were alive and free of disease (malignancy) at 12 months after transplant. | 12 Months Post transplant |
| Number of Patients Who Were Disease-free and Alive at 24 Months |
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Inclusion Criteria:
Diagnosis of 1 of the following:
Unrelated umbilical cord blood (UCB) donor(s) available - Each unit must be 4-6/6 HLA-A, -B, and -DRB1 matched with the recipient (and to each other if 2 units are utilized) (for UCB graft) AND 3/6 HLA-A, -B, and -DRB1 matched with the recipient (for UCB natural killer [NK] cells)
Karnofsky performance status (PS) 80-100% (adult patients) or Lansky PS 50-100% (pediatric patients)
Creatinine ≤ 2.0 mg/dL (adult patients) OR creatinine clearance > 40 mL/min (pediatric patients)
Bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
Corrected Carbon Monoxide Diffusing Capacity (DLCO) > 50% normal OR oxygen saturation > 92% (in pediatric patients who cannot undergo pulmonary function tests)
Left ventricular ejection fraction ≥ 45%
Exclusion Criteria:
Pregnant or nursing
Positive pregnancy test (Fertile patients must use effective contraception)
History of HIV infection
Active infection at time of transplantation
Less than 6 months since prior myeloablative transplant (≤ 18 years old)
Prior myeloablative allotransplant or autologous transplant (> 18 years old)
No prior extensive therapy including > 12 months of any alkylator chemotherapy or > 6 months of alkylator therapy with extensive radiation (e.g., mantle irradiation for Hodgkin's lymphoma)
Prior radiation therapy that would make the patient ineligible for total-body irradiation
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Miller, MD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Treated for Refractory Hematologic Cancers | All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| filgrastim | Biological | All patients will receive filgrastim (same as granulocyte-colony stimulating factor or G-CSF) 5 mcg/kg/day intravenous (IV) (dose rounded to vial size) based on the actual body weight beginning on day +1 after umbilical cord blood (UCB) infusion. Granulocyte Colony Stimulating Factor (G-CSF) will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10^9/L for three consecutive days and then discontinued. If the ANC decreases to <1.0 x 10^9/L, G-CSF will be reinstituted. |
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| natural killer cell (NK) therapy | Biological | All CD3 depleted cells will be given (less those required for product monitoring). The minimum size of a starting NK cell unit will be 700 million mononuclear cells before processing. NK cells (CD56+) and NK cell precursors (CD34+/CD7-, CD34+/CD7+, CD34-/CD7+) will be monitored and reported but will not serve as lot release. |
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| cyclophosphamide | Drug | Cyclophosphamide to be administered with high volume fluid flush and mesna on days-18 and -17 after fludarabine. Cyclophosphamide 60 mg/kg/day intravenously (IV) x 2 days, total dose 120 mg/m2 (days -18 and -17) |
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| cyclosporine | Drug | Patients will receive cyclosporine (CSA) therapy beginning on day -1 maintaining a level of >200 ng/mL. For adults the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours. For children <40 kg the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours. |
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| fludarabine phosphate | Drug | Fludarabine 25 mg/m2/day intravenously (IV) x 3 days, total dose 75 mg/m2 (days -18 to -16) |
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| methylprednisolone | Drug | This modification will be enacted based on the engraftment stopping rule on all subsequent patients to stop natural killer (NK) cell reaction. Methylprednisolone bolus 1000 mg intravenously (IV) will be administered day -1 and day 0 (before umbilical cord blood transplant) to suppress natural killer (NK) cell activity before transplant. Starting cyclosporin and mycophenolate mofetil (MMF) will also contribute to suppressing residual NK cell activity. |
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| mycophenolate mofetil | Drug | All patients will begin mycophenolate mofetil (MMF) on day -1. Patients ≥ 45 kilograms will receive MMF at the dose of 3 grams/day divided into 2 or 3 doses. Pediatric patient (<45 kilograms) will receive MMF at the dose of 15 mg/kg. Use intravenous (IV) route between days -1 and +5, then, if tolerated, may change to by mouth (PO) between days +6 and +30. Stop MMF at day +30 or 7 days after engraftment, whichever day is later, if no acute Graft Versus Host Disease. (Definition of engraftment is 1st day of 3 consecutive days of absolute neutrophil count [ANC] > 0.5 x 10^9 /L). |
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| Umbilical Cord Blood Transplantation (UCBT) | Procedure | The product is infused via intravenous (IV) drip directly into the central line without a needle, pump or filter. |
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| Total body irradiation (TBI) | Radiation | TBI 165 Gray (cGy) will be given twice daily for a total dose of 1320 cGy (days -16 to -13). |
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Number of patients who were alive and free of disease (malignancy) at 24 months after transplant. |
| 24 Months Post transplant |
| Number of Participants (Patients) Who Died Due to Transplant. | Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months. | 6 Months Post Transplant |
| Number of Participants (Patients) Who Attained Neutrophil Engraftment | Defined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days. ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3). | Day 42 Post Transplant |
| Number of Participants (Patients) Who Attained Platelet Engraftment | Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days. | 1 Year Post Transplant |
| Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV | Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. | Day 100 Post Transplant |
| Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV | Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. | Day 100 post transplant |
| Number of Participants (Patients) With Chronic Graft-Versus-Host Disease | The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival. | Day 100 through 1 Year Post Transplant |
| Number of Participants (Patients) Who Died by 12 Months | Number of patients who died after receiving treatment within 12 months post transplant. | 1 year Post Transplant |
| Number of Participants (Patients) Who Died by 24 Months | Number of patients who died after receiving treatment within 24 months post transplant. | 2 years post-transplant |
| Number of Participants (Patients) Who Experienced Relapse by 12 Months | Number of patients who experienced recurrence or progression of disease from the time of transplant. | 1 Year Post Transplant |
| Number of Participants (Patients) Who Experienced Relapse by 24 Months | Number of patients who experienced recurrence or progression of disease from the time of transplant. | 2 Years Post transplant |
| Number of Participants (Patients) With Successful Natural Killer Cell Expansion | Defined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population | 10-13 Days Post Infusion |
| Chimerism After Double Umbilical Cord Blood Transplant (UCBT) | Calculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient). | Day 21, Day 100, 6 Months |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Treated for Refractory Hematologic Cancers | All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 (Patients) Who Were Disease-free and Alive at 6 Months | Number of patients who were alive and free of disease (malignancy) at 6 months after transplant. | One patient did not receive umbilical cord transplant and was not included in this Evaluable patient group. | Posted | Nov 2009 | Number | Participants | 6 Months Post Transplant |
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| Secondary | Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months | Number of patients who were alive and free of disease (malignancy) at 12 months after transplant. | Posted | Nov 2009 | Number | Participants | 12 Months Post transplant |
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| Secondary | Number of Patients Who Were Disease-free and Alive at 24 Months | Number of patients who were alive and free of disease (malignancy) at 24 months after transplant. | Posted | Nov 2009 | Number | Participants | 24 Months Post transplant |
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| Secondary | Number of Participants (Patients) Who Died Due to Transplant. | Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months. | Posted | Nov 2009 | Number | Participants | 6 Months Post Transplant |
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| Secondary | Number of Participants (Patients) Who Attained Neutrophil Engraftment | Defined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days. ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3). | Posted | Nov 2009 | Number | Participants | Day 42 Post Transplant |
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| Secondary | Number of Participants (Patients) Who Attained Platelet Engraftment | Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days. | Posted | Nov 2009 | Number | Participants | 1 Year Post Transplant |
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| Secondary | Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV | Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. | Posted | Nov 2009 | Number | Participants | Day 100 Post Transplant |
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| Secondary | Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV | Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. | Posted | Nov 2009 | Number | Participants | Day 100 post transplant |
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| Secondary | Number of Participants (Patients) With Chronic Graft-Versus-Host Disease | The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival. | Posted | Nov 2009 | Number | Participants | Day 100 through 1 Year Post Transplant |
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| Secondary | Number of Participants (Patients) Who Died by 12 Months | Number of patients who died after receiving treatment within 12 months post transplant. | Posted | Nov 2009 | Number | Participants | 1 year Post Transplant |
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| Secondary | Number of Participants (Patients) Who Died by 24 Months | Number of patients who died after receiving treatment within 24 months post transplant. | Posted | Nov 2009 | Number | Participants | 2 years post-transplant |
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| Secondary | Number of Participants (Patients) Who Experienced Relapse by 12 Months | Number of patients who experienced recurrence or progression of disease from the time of transplant. | Posted | Nov 2009 | Number | Participants | 1 Year Post Transplant |
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| Secondary | Number of Participants (Patients) Who Experienced Relapse by 24 Months | Number of patients who experienced recurrence or progression of disease from the time of transplant. | Posted | Nov 2009 | Number | Participants | 2 Years Post transplant |
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| Secondary | Number of Participants (Patients) With Successful Natural Killer Cell Expansion | Defined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population | Posted | Nov 2009 | Number | Participants | 10-13 Days Post Infusion |
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| Secondary | Chimerism After Double Umbilical Cord Blood Transplant (UCBT) | Calculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient). | 1 Year and 2 Year Post Transplant data was not applicable; no patients reached this timeframe to evaluate. | Posted | Nov 2009 | Median | Full Range | Percentage of Engrafted Cells | Day 21, Day 100, 6 Months |
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Serious adverse events were collected if deemed related to treatment from Day 1 through 1 year post transplant. It was expected that most treatment related adverse events would occur during this period.
Only serious adverse events were captured for this study.
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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 | Patients Treated for Refractory Hematologic Cancers | All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant. | 16 | 16 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Death | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Death was due to transplant procedure. |
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| Disease relapse | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hemorrhage, lung | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hepatic portal vein flow occluded | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Miller, M.D. | Masonic Cancer Center, University of Minnesota | 612-625-7409 | mille011@umn.edu |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| D000013 | Congenital Abnormalities |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D001752 | Blast Crisis |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007951 | Leukemia, Myeloid |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D009196 | Myeloproliferative Disorders |
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| ID | Term |
|---|---|
| C082598 | aldesleukin |
| D007376 | Interleukin-2 |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D013812 | Therapeutics |
| D003520 | Cyclophosphamide |
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D008775 | Methylprednisolone |
| D008776 | Methylprednisolone Hemisuccinate |
| D000077555 | Methylprednisolone Acetate |
| D009173 | Mycophenolic Acid |
| D036101 | Cord Blood Stem Cell Transplantation |
| D014184 | Transplantation, Homologous |
| D014916 | Whole-Body Irradiation |
| D011827 | Radiation |
| ID | Term |
|---|---|
| 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 |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| D008919 | Investigative Techniques |
| D055585 | Physical Phenomena |
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