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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00150 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2468.00A | |||
| 2468 | |||
| 2468.00 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P01CA044991 | U.S. NIH Grant/Contract | View source | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase I trial studies the side effects and maximum tolerated dose of yttrium Y 90 anti-cluster of differentiation 45 (CD45) monoclonal antibody BC8 (90Y-BC8) followed by donor stem cell transplant in treating patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) that is likely to come back or spread. Giving chemotherapy drugs, such as fludarabine phosphate (FLU), and total-body irradiation (TBI) before a donor peripheral blood stem cell (PBSC) or bone marrow transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies, such as 90Y-BC8, can find cancer cells and carry cancer-killing substances to them without harming normal 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 FLU, 90Y-BC8, and TBI before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PRIMARY OBJECTIVES:
I. To estimate the maximum tolerated dose (MTD) of radiation delivered via 90Y-DOTA-BC8 (90Y-BC8) when combined with FLU and 2 Gy TBI as a preparative regimen for patients aged >= 18 with advanced AML, ALL, and high-risk MDS.
SECONDARY OBJECTIVES:
I. To determine disease response and duration of remission.
II. To determine the rates of engraftment and donor chimerism resulting from this combined preparative regimen, and to correlate level of donor chimerism with estimated radiation doses delivered to hematopoietic tissues via antibody.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12 and FLU intravenously (IV) over 30 minutes on days -4 to -2.
TRANSPLANTATION: Patients undergo TBI followed by allogeneic PBSC or bone marrow transplant on day 0.
GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive mycophenolate mofetil orally (PO) or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180.
After completion of study treatment, patients are followed up at 6, 9, 12, 18, and 24 months, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Y-90-BC8 & Allogeneic Transplant | Experimental | PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Bone Marrow Transplantation | Procedure | Undergo allogeneic bone marrow transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| The MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS. | The MTD will be defined as the dose that is associated with a true DLT rate of 25%. The highest dose achieved was 28 Gy but none of the patients experienced a DLT. Thus, the MTD was not reached. | Within the first 30 days following transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of Remission | Number of participants who are in complete remission (CR) 4 weeks after transplant. CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following:
|
Not provided
Inclusion Criteria:
Patients must have advanced AML, ALL or high-risk MDS meeting one of the following descriptions:
Patients not in remission must have CD45-expressing leukemic blasts; patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up >= 95% of nucleated cells in the marrow)
Patients should have a circulating blast count of less than 10,000/mm^3 (control with hydroxyurea or similar agent is allowed)
Patients must have an estimated creatinine clearance greater than 50/ml per minute (serum creatinine value must be within 28 days prior to registration)
Bilirubin < 2 times the upper limit of normal
Aspartate aminotransferase (AST) and alanine transaminase (ALT) < 2 times the upper limit of normal
Eastern Cooperative Oncology Group (ECOG) =< 2 or Karnofsky >= 70
Patients must have an expected survival of > 60 days and must be free of active infection
Patients must have an human leukocyte antigen (HLA)-identical sibling donor or an HLA-matched unrelated donor who meets standard Seattle Cancer Care Alliance (SCCA) and/or National Marrow Donor Program (NMDP) or other donor center criteria for PBSC or bone marrow donation, as follows:
Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing
Unrelated donor:
DONOR: Donors must meet HLA matching criteria and standard SCCA and/or National Marrow Donor Program (NMDP) or other donor center criteria for PBSC or bone marrow donation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brenda Sandmaier | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31582553 | Derived | Vo P, Gooley TA, Rajendran JG, Fisher DR, Orozco JJ, Green DJ, Gopal AK, Haaf R, Nartea M, Storb R, Appelbaum FR, Press OW, Pagel JM, Sandmaier BM. Yttrium-90-labeled anti-CD45 antibody followed by a reduced-intensity hematopoietic cell transplantation for patients with relapsed/refractory leukemia or myelodysplasia. Haematologica. 2020 Jun;105(6):1731-1737. doi: 10.3324/haematol.2019.229492. Epub 2019 Oct 3. |
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This protocol is open to participants age 18 and above, of either gender and any race/ethnicity. The study is looking at the use of Y-90-DOTA-BC8 in conjunction with a standard reduced-intensity transplant regimen.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) | PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or bone marrow transplant Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Indium In 111 Anti-CD45 Monoclonal Antibody BC8: Given IV (dosimetric dose) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2016 |
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| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | Undergo allogeneic PBSC or bone marrow transplant |
|
|
| Cyclosporine | Drug | Given PO or IV |
|
|
| Fludarabine Phosphate | Drug | Given IV |
|
|
| Indium In 111 Anti-CD45 Monoclonal Antibody BC8 | Biological | Given IV (dosimetric dose) |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Mycophenolate Mofetil | Drug | Given PO or IV |
|
|
| Peripheral Blood Stem Cell Transplantation | Procedure | Undergo allogeneic PBSC transplant |
|
|
| Pharmacological Study | Other | Correlative studies |
|
| Total-Body Irradiation | Radiation | Undergo TBI |
|
|
| Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8 | Radiation | Given via central line (therapeutic dose) |
|
|
| 4 weeks after transplant |
| Disease-free Survival | Number of study participants who are alive and remains in complete remission after transplant. | 100 days after transplant |
| Duration of Remission | Median time to relapse after achieving complete remission (CR). CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following:
Relapse Criteria:
| 1 year |
| Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor | The amount of energy absorbed per unit weight of the organ or tissue is called absorbed dose and is expressed in units of gray (Gy). One gray dose is equivalent to one joule radiation energy absorbed per kilogram of organ or tissue weight. | Approximately day -20 to day -12 prior to transplant |
| Overall Survival | Number of participants who are still alive after transplant with or without disease. | Up to 5 years |
| Rates of Acute GvHD | Number of participants who developed acute GVHD post-transplant, aGVHD stages: Skin: a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death | Up to 84 days post-transplant |
| Rates of Donor Chimerism | Number of participants who has 100% donor chimerism within 100 days after transplant | Up to 100 days post-transplant |
| Rates of Engraftment | Average number of days to ANC >= 500 after transplant | Up to 84 days post-transplant |
| Rates of Non-relapse Mortality | Transplant-related deaths within 100 days after transplant | Within the first 100 days following transplant |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) | Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with ~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose. |
| 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 |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | 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 | The MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS. | The MTD will be defined as the dose that is associated with a true DLT rate of 25%. The highest dose achieved was 28 Gy but none of the patients experienced a DLT. Thus, the MTD was not reached. | Study participants who completed the study regimen. | Posted | Number | Gy | Within the first 30 days following transplant |
|
|
| ||||||||||||||||||||||||||
| Secondary | Achievement of Remission | Number of participants who are in complete remission (CR) 4 weeks after transplant. CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following:
| Study participants who completed the study regimen | Posted | Count of Participants | Participants | 4 weeks after transplant |
| ||||||||||||||||||||||||||||
| Secondary | Disease-free Survival | Number of study participants who are alive and remains in complete remission after transplant. | Study participants who completed study regimen and in CR after transplant. | Posted | Number | participants | 100 days after transplant |
|
| |||||||||||||||||||||||||||
| Secondary | Duration of Remission | Median time to relapse after achieving complete remission (CR). CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following:
Relapse Criteria:
| Study participants who relapsed after achieving complete remission after transplant. | Posted | Median | Full Range | days | 1 year |
| |||||||||||||||||||||||||||
| Secondary | Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor | The amount of energy absorbed per unit weight of the organ or tissue is called absorbed dose and is expressed in units of gray (Gy). One gray dose is equivalent to one joule radiation energy absorbed per kilogram of organ or tissue weight. | All study participants who completed the study regimen. | Posted | Mean | Standard Deviation | Gy | Approximately day -20 to day -12 prior to transplant |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | Number of participants who are still alive after transplant with or without disease. | Posted | Count of Participants | Participants | Up to 5 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Rates of Acute GvHD | Number of participants who developed acute GVHD post-transplant, aGVHD stages: Skin: a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death | Overall number of participants analyzed is 14 because one patient died prior to d+84 after transplant. | Posted | Count of Participants | Participants | Up to 84 days post-transplant |
| ||||||||||||||||||||||||||||
| Secondary | Rates of Donor Chimerism | Number of participants who has 100% donor chimerism within 100 days after transplant | Overall number of participants analyzed is 14 because one patient died prior to d+84 after transplant. | Posted | Count of Participants | Participants | Up to 100 days post-transplant |
|
| |||||||||||||||||||||||||||
| Secondary | Rates of Engraftment | Average number of days to ANC >= 500 after transplant | Study participants with an ANC <= to 500 after transplant | Posted | Mean | Standard Deviation | days | Up to 84 days post-transplant |
|
| ||||||||||||||||||||||||||
| Secondary | Rates of Non-relapse Mortality | Transplant-related deaths within 100 days after transplant | Posted | Count of Participants | Participants | Within the first 100 days following transplant |
|
|
Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician.
Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.
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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 | Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) | PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0. | 5 | 15 | 9 | 15 | 11 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE) Version 4.0 | Systematic Assessment | Cellulitis |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE) Version 4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Mucositis, oral | Gastrointestinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Edema trunk | General disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Coag negative staph infection | Infections and infestations | CTCAE) Version 4.0 | Systematic Assessment |
| |
| CMV reactivation | Infections and infestations | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Upper respiratory infection - Rhinovirus | Infections and infestations | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Upper respiratory infection - Rhinorrea | Infections and infestations | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Upper respiratory infection - Metapneumovirus | Infections and infestations | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Muscle weakness, lower limb | Musculoskeletal and connective tissue disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Muscle weakness, trunk | Musculoskeletal and connective tissue disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE) Version 4.0 | Systematic Assessment |
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| Hallucinations | Psychiatric disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE) Version 4.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE) Version 4.0 | Systematic Assessment |
|
The highest dose achieved was 28 Gy but none of the patients experienced a DLT. Thus, the MTD was not reached.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brenda Sandmaier, MD | Fred Hutchinson Cancer Research Center | (206) 667-4961 | bsandmai@fredhtuch.org |
| Oct 12, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
Not provided
Not provided
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D003524 | Cyclosporins |
| C042382 | fludarabine phosphate |
| D007204 | Indium |
| D009173 | Mycophenolic Acid |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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|
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| Units | Counts |
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| Participants |
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| Participants |
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