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| ID | Type | Description | Link |
|---|---|---|---|
| P01CA030206 | U.S. NIH Grant/Contract | View source | |
| CHNMC-05149 | |||
| CDR0000579136 | Registry Identifier | NCI PDQ | |
| NCI-2010-01230 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Giving monoclonal antibody therapy, radioimmunotherapy, and chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor that do not exactly match the patient's blood, 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 also make an immune response against the body's normal cells. Giving tacrolimus and sirolimus before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects and how well giving indium In 111 ibritumomab tiuxetan and yttrium y 90 ibritumomab tiuxetan together with rituximab, fludarabine, melphalan, and donor stem cell transplant works in treating patients with B-cell non-Hodgkin lymphoma.
PRIMARY OBJECTIVES: I. To evaluate the safety and efficacy of a preparative regimen of Yttrium-90 (90^Y)- labeled anti-cluster of differentiation (CD)20 monoclonal antibody (MAb) (yttrium Y 90 ibritumomab tiuxetan) in combination with fludarabine (fludarabine phosphate) and melphalan followed by allogeneic hematopoietic stem cell transplant (APBSCT) for treatment of patients with B-cell low-grade non-Hodgkin lymphoma (LG NHL), intermediate-grade non-Hodgkin lymphoma (IG NHL) and mantle cell lymphoma (MCL). II. To evaluate the short- and long-term complications of this new preparative regimen, including rates of engraftment, acute and chronic graft-versus-host-disease (GVHD) and infectious complications. III. To estimate the disease response rate, disease relapse (progression) rate, and non-relapse mortality rate. IV. To perform exploratory studies that seek to measure/characterize the expression of costimulatory molecules and impact of these molecules on the natural killer (NK) and T cells of a subset of lymphoma patients pre- post- allogeneic stem cell transplant (ASCT) and the stem cell product from a portion of sibling donors.
OUTLINE: REDUCED-INTENSITY CONDITIONING: Patients receive rituximab intravenously (IV) followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4.
STEM CELL TRANSPLANTATION: Patients undergo APBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or orally (PO) and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (chemo, monoclonal antibody therapy, transplant) | Experimental | REDUCED-INTENSITY CONDITIONING: Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. STEM CELL TRANSPLANTATION: Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse/Progression Rate at Two Years | The primary endpoint was 2-year cumulative incidence of relapse/progression (RP), defined as time from alloHCT to disease recurrence or progression. Cumulative incidences for RP was generated in a competing-risk setting, given that death events were competing events. | From the initial treatment to the last disease assessment, up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at Two Years | Overall survival (OS) was measured from initial treatment to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. | From the initial treatment to the last disease assessment, up to two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Mei, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010-3000 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37301631 | Derived | Mei M, Palmer J, Tsai NN, Simpson J, O'Hearn J, Stein A, Forman S, Spielberger R, Cai JL, Htut M, Nakamura R, Al Malki MM, Herrera A, Wong J, Nademanee A. Results of a Phase II Trial of Allogeneic Hematopoietic Stem Cell Transplantation Using 90Y-Ibritumomab Tiuxetan (Zevalin) in Combination With Fludarabine and Melphalan in Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma. Clin Lymphoma Myeloma Leuk. 2023 Sep;23(9):e268-e276. doi: 10.1016/j.clml.2023.05.011. Epub 2023 May 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.4 mCi 90Y-Ibritumomab Tiuxetan | Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper. rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV |
| 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 | Dec 11, 2013 |
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| fludarabine phosphate | Drug | Given IV |
|
|
| melphalan | Drug | Given IV |
|
|
| sirolimus | Drug | Given PO |
|
|
| tacrolimus | Drug | Given PO or IV |
|
|
| allogeneic hematopoietic stem cell transplantation | Procedure | Undergo APBSCT |
|
| indium In 111 ibritumomab tiuxetan | Radiation | Given IV |
|
|
| yttrium Y 90 ibritumomab tiuxetan | Radiation | Given IV |
|
|
| laboratory biomarker analysis | Other | Correlative Studies |
|
| Progression-free Survival at Two Years |
Progression-free survival (PFS) was measured from initial treatment to disease progression or death from any cause, whichever came first. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. |
| From the initial treatment to the last disease assessment, up to two years |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.4 mCi 90Y-Ibritumomab Tiuxetan | Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper. rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | 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 | Relapse/Progression Rate at Two Years | The primary endpoint was 2-year cumulative incidence of relapse/progression (RP), defined as time from alloHCT to disease recurrence or progression. Cumulative incidences for RP was generated in a competing-risk setting, given that death events were competing events. | Posted | Number | 95% Confidence Interval | percentage of cumulative incidence | From the initial treatment to the last disease assessment, up to two years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival at Two Years | Overall survival (OS) was measured from initial treatment to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. | Posted | Number | 95% Confidence Interval | percentage of survival probability | From the initial treatment to the last disease assessment, up to two years |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival at Two Years | Progression-free survival (PFS) was measured from initial treatment to disease progression or death from any cause, whichever came first. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. | Posted | Number | 95% Confidence Interval | percentage of survival probability | From the initial treatment to the last disease assessment, up to two years |
|
|
From initial treatment to off study, up to 5 years.
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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 | 0.4 mCi 90Y-Ibritumomab Tiuxetan | Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper. rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV | 24 | 41 | 28 | 41 | 41 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chyle or lymph leakage | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hemorrhage, GI | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thrombosis/embolism (vascular access-related) | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pericardial effusion (non-malignant) | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ascites (non-malignant) | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic) | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Fever | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hepatobiliary/Pancreas - Other (Specify, __) | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Liver dysfunction/failure (clinical) | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pancreatitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Colitis, infectious (e.g., Clostridium difficile) | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection, Bacterial | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection, Fungal | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection, Viral | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Opportunistic infection associated with >=Grade 2 Lymphopenia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Viral hepatitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Acidosis (metabolic or respiratory) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Amylase | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Lipase | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Secondary Malignancy - possibly related to cancer treatment (Specify, __) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Mood alteration | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Obstruction, GU | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Induration/fibrosis (skin and subcutaneous tissue) | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow cellularity | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| DIC (disseminated intravascular coagulation) | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Edema:head and neck | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Edema:limb | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Edema:trunk/genital | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Haptoglobin | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hematoma | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hemorrhage, GI | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hemorrhage, GU | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other (Specify, __) | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| INR (International Normalized Ratio of prothrombin time) | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Iron overload | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Lymphatics - Other (Specify, __) | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| PTT (Partial Thromboplastin Time) | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Phlebitis (including superficial thrombosis) | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thrombosis/embolism (vascular access-related) | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiac General - Other (Specify, __) | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Conduction abnormality/atrioventricular heart block | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Left ventricular diastolic dysfunction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pericardial effusion (non-malignant) | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Prolonged QTc interval | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pulmonary hypertension | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hearing | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cushingoid appearance | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hot flashes/flushes | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neuroendocrine:ADH secretion abnormality (e.g., SIADH or low ADH) | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pancreatic endocrine: glucose intolerance | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thyroid function, low (hypothyroidism) | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nystagmus | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ocular surface disease | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ocular/Visual - Other (Specify, __) | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ophthalmoplegia/diplopia (double vision) | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Proptosis/enophthalmos | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Watery eye (epiphora, tearing) | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ascites (non-malignant) | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dental: teeth | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Distension/bloating, abdominal | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Gastrointestinal - Other (Specify, __) | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic) | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Salivary gland changes/saliva | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Stricture/stenosis (including anastomotic), GI | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Taste alteration (dysgeusia) | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ulcer, GI | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Constitutional Symptoms - Other (Specify, __) | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Fever | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Insomnia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pain - Other (Specify, __) | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Sweating (diaphoresis) | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Weight gain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Weight loss | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Liver dysfunction/failure (clinical) | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pancreatitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Autoimmune reaction | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Colitis, infectious (e.g., Clostridium difficile) | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection - Other (Specify, __) | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection with unknown ANC | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection, Bacterial | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection, Fungal | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection, Viral | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Opportunistic infection associated with >=Grade 2 Lymphopenia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Acidosis (metabolic or respiratory) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Alkalosis (metabolic or respiratory) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Amylase | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Bicarbonate, serum-low | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| CPK (creatine phosphokinase) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Calcium, serum-high (hypercalcemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Cholesterol, serum-high (hypercholesteremia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Creatinine | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| GGT (gamma-Glutamyl transpeptidase) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Glucose, serum-low (hypoglycemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Hemoglobinuria | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Lipase | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Magnesium, serum-high (hypermagnesemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Phosphate, serum-low (hypophosphatemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Proteinuria | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Sodium, serum-high (hypernatremia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Triglyceride, serum-high (hypertriglyceridemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Uric acid, serum-high (hyperuricemia) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Extremity-lower (gait/walking) | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Joint-effusion | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy) | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other (Specify, __) | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Osteonecrosis (avascular necrosis) | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Secondary Malignancy - possibly related to cancer treatment (Specify, __) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Extrapyramidal/involuntary movement/restlessness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Mental status | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Mood alteration | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neurology - Other (Specify, __) | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neuropathy: cranial | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Psychosis (hallucinations/delusions) | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Somnolence/depressed level of consciousness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bladder spasms | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Incontinence, urinary | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Obstruction, GU | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Urine color change | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Libido | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Adult Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Carbon monoxide diffusion capacity (DL(co)) | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Edema, larynx | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| FEV(1) | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nasal cavity/paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, __) | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vital capacity | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Syndromes - Other (Specify, __) | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Burn | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Induration/fibrosis (skin and subcutaneous tissue) | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Injection site reaction/extravasation changes | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Urticaria (hives, welts, wheals) | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Mei | City of Hope Medical Center | 626-359-8111 | mamei@coh.org |
| Nov 23, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008258 | Waldenstrom Macroglobulinemia |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D020522 | Lymphoma, Mantle-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D016393 | Lymphoma, B-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C042382 | fludarabine phosphate |
| D008558 | Melphalan |
| D020123 | Sirolimus |
| D016559 | Tacrolimus |
| D007204 | Indium |
| C422802 | ibritumomab tiuxetan |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D018942 | Macrolides |
| D007783 | Lactones |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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 |
|
|
|