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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-03094 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HEMALL0008 | Other Identifier | OnCore Number | |
| IRB-25596 | Other Identifier | Stanford IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study evaluates the value of bortezomib in combination with specified chemotherapies for the treatment of patients with relapsed or refractory acute lymphoblastic leukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVE:
Determine the response rate of bortezomib in combination with a chemotherapy backbone of doxorubicin (doxorubicin hydrochloride), vincristine (vincristine sulfate), PEG-asparaginase (pegaspargase), and dexamethasone in patients with relapsed/refractory acute lymphoblastic leukemia.
SECONDARY OBJECTIVES:
OUTLINE:
Patients receive bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11; doxorubicin hydrochloride intravenously (IV) on day 1; pegaspargase IV or intramuscularly (IM) on Days 5 and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) daily on Days 1 to 14; cytarabine intrathecally (IT) on Day 1 and methotrexate intrathecally (IT) on Day 15. Patients with central nervous system disease receive intrathecal treatment per investigator's discretion.
Participants are followed up every 3 months for up to 2 years after completion of study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bortezomib + Chemotherapy | Experimental | Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (RR) | Response Rate (RR) was determined as the sum of complete response (CR) and partial response (PR). Due to overlap, "complete response rate without platelet recovery" (CRp) is not included in Response Rate (RR). The outcome is reported as the total number without dispersion.
| Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) | Complete response (CR) was determined the number of participants who achieved CR by Day 29 after induction treatment. The outcome is reported as the total number without dispersion. CR is defined as:
|
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INCLUSION CRITERIA
Voluntary written informed consent
Female subjects who:
Male subjects, even if surgically sterilized (ie, status post vasectomy) who:
• Relapsed or refractory B or T cell acute lymphoblastic leukemia that has progressed following at least one prior therapy. Ph+ patients are eligible. Relapsed ALL is defined in patients as the reappearance of leukemia cells in the peripheral blood or bone marrow or appearance of extramedullary disease after a complete remission. Refractory ALL is defined in patients as failure to achieve a complete remission after induction therapy. Complete remission is defined by <5% leukemia cells in the bone marrow with recovery of peripheral blood counts. Relapsed disease can be documented by bone marrow biopsy (>5% cells in the bone marrow) or by flow cytometry in the peripheral blood or biopsy of extramedullary disease.
Has received at least 1 line of prior systemic therapy that may NOT have included bortezomib (Velcade); patients who have undergone autologous/allogeneic stem cell transplantation are eligible
Transplant-eligible patients are eligible
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
No poorly-controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, or psychiatric illness that in the opinion of the investigator would limit compliance with study requirements
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 x (ULN unless elevation is deemed due to leukemia infiltration)
Adequate renal function defined as creatinine clearance of ≥ 30 mL/minute by the Cockcroft-Gault method
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Michaela Liedtke, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bortezomib + Chemotherapy | Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Doxorubicin hydrochloride (HCl) | Drug | Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. |
|
|
| PEG-Asparaginase | Drug | Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. |
|
|
| Vincristine sulfate | Drug | Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. |
|
|
| Dexamethasone | Drug | Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. |
|
|
| Cytarabine | Drug | Administered intrathecally (IT) at 100 mg, on Day 1 |
|
|
| Methotrexate | Drug | Administered intrathecally (IT) at 15 mg, on Day 15. |
|
|
| Day 29 |
| Complete Response Without Platelet Recovery (CRp) | Complete response without platelet recovery (CR) was determined as the number of participants who achieved CRp by Day 29 after induction treatment. The outcome is reported as the total number without dispersion. The outcome reflects only those subjects that meet all complete response (CR) criteria except platelet count; participants that meet all criteria including platelet count are not included in this outcome. CR and CRp are defined below.
| Day 29 |
| Progression-free Survival (PFS) | Progression-free survival (PFS) was assessed as survival without progression at 2 years. The outcome is reported as the number (without dispersion) of the participants alive without progression. Progression = More than 25% increase in circulating and/or bone marrow blasts, or the development of extramedullary disease. | 2 years |
| Failure-free Survival (FFS) | Failure-free survival (FFS) was assessed as survival without progression or the addition of another systemic therapy, at or within 2 years. The outcome is reported as the number (without dispersion) of the participants alive without progression. Progression is defined below. Progression = More than 25% increase in circulating and/or bone marrow blasts, or the development of extramedullary disease. | 1 year |
| Overall Survival (OS) | Overall survival (OS) was assessed as participants remaining alive 2 years after induction therapy. The outcome is reported as the number of participants (without dispersion). | 2 years |
| Related Adverse Events (Grade 3, 4, 5) | Toxicity was assessed as related grade 3, 4, or 5 adverse events (AEs) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. The outcome is reported as the total numbers of events (without dispersion) by CTCAE Body System, and whether the event was a hematologic toxicity or non-hematologic toxicity. | 45 days |
| Induction of Reactive Oxygen Species (ROS) | Circulating acute lymphoblastic leukemia (ALL) blast cells were to be evaluated for the presence of reactive oxygen species (ROS). | 2 years |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bortezomib + Chemotherapy | Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15. |
| 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 |
| ||||||||||||||||||||
| Age, Continuous | Median | Standard Deviation | 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 | Response Rate (RR) | Response Rate (RR) was determined as the sum of complete response (CR) and partial response (PR). Due to overlap, "complete response rate without platelet recovery" (CRp) is not included in Response Rate (RR). The outcome is reported as the total number without dispersion.
| Posted | Count of Participants | Participants | Day 29 |
|
|
| |||||||||||||||||||||||||||
| Secondary | Complete Response (CR) | Complete response (CR) was determined the number of participants who achieved CR by Day 29 after induction treatment. The outcome is reported as the total number without dispersion. CR is defined as:
| Posted | Count of Participants | Participants | Day 29 |
|
| ||||||||||||||||||||||||||||
| Secondary | Complete Response Without Platelet Recovery (CRp) | Complete response without platelet recovery (CR) was determined as the number of participants who achieved CRp by Day 29 after induction treatment. The outcome is reported as the total number without dispersion. The outcome reflects only those subjects that meet all complete response (CR) criteria except platelet count; participants that meet all criteria including platelet count are not included in this outcome. CR and CRp are defined below.
| Posted | Count of Participants | Participants | Day 29 |
| |||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | Progression-free survival (PFS) was assessed as survival without progression at 2 years. The outcome is reported as the number (without dispersion) of the participants alive without progression. Progression = More than 25% increase in circulating and/or bone marrow blasts, or the development of extramedullary disease. | Posted | Count of Participants | Participants | 2 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Failure-free Survival (FFS) | Failure-free survival (FFS) was assessed as survival without progression or the addition of another systemic therapy, at or within 2 years. The outcome is reported as the number (without dispersion) of the participants alive without progression. Progression is defined below. Progression = More than 25% increase in circulating and/or bone marrow blasts, or the development of extramedullary disease. | Posted | Count of Participants | Participants | 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival (OS) was assessed as participants remaining alive 2 years after induction therapy. The outcome is reported as the number of participants (without dispersion). | Posted | Count of Participants | Participants | 2 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Related Adverse Events (Grade 3, 4, 5) | Toxicity was assessed as related grade 3, 4, or 5 adverse events (AEs) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. The outcome is reported as the total numbers of events (without dispersion) by CTCAE Body System, and whether the event was a hematologic toxicity or non-hematologic toxicity. | Events specifically defined per protocol as "Hematologic Toxicity" or"Non-hematologic Toxicity" are included under the specific Body System and as a Hematologic or Non-hematologic Toxicity. | Posted | Number | Treatment-related adverse events | 45 days |
| ||||||||||||||||||||||||||||
| Secondary | Induction of Reactive Oxygen Species (ROS) | Circulating acute lymphoblastic leukemia (ALL) blast cells were to be evaluated for the presence of reactive oxygen species (ROS). | Assay development was unsuccessful, and the assessment and analysis were not conducted for any samples. | Posted | 2 years |
|
|
2 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 | Bortezomib + Chemotherapy | Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15. | 13 | 18 | 10 | 18 | 18 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenic fever (febrile neutropenia) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Disseminated intravascular coagulation (DIC) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Colon and caecum inflammation (typhilitis, colitis) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatobilliary Disorders-Other, veno-occlusive disease | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Septic shock (sepsis) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenic fever (febrile neutropenia) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Heart palpitations (tachycardia) | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Heart failure (congestive heart failure) | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Decreased hearing (hearing impaired) | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry eyes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting (nausea) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease (GERD) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Colon and caecum inflammation (typhilitis, colitis) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Perianal pain ( Anal pain) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Swelling (edema) | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatobilliary Disorders-Other, liver abscess | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations-Other,thrush | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory infections | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations-Other, Herpes simplex virus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Septic shock (sepsis) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory syncytial virus (RSV) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations-Other, Herpes simplex virus Line, sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Fibrinogen decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Partial thromboplastin time (PTT) high | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase (AST) elevated | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase (ALT) elevated | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Bilirubin elevated | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline Phosphatase elevated | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Gamma-glutamyl transferase (GGT) elevated | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Amylase high | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lipase high | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine high | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Apetite loss (anorexia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia (Albumin low) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertriglyceridemia (Triglycerides high) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia -Sodium high | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia -Sodium low | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia -Potassium low | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia -Potassium high | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia -Magnesium low | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia -Calcium low | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia -Phosphorus low | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolism and Nutrition Disorders-Other Phosphorus high | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia (Glucose high) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglycemia -Glucose low | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Leg weakness (generalized muscle weakness ) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, musculoskeletal Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Avascular necrosis (Bone infarct) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Seizures | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Restless leg (akathisia) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain during urination (dysuria) | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Scrotal pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Breath shortness (Dyspnea) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest pain (pleuritic pain) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nosebleed (Epistaxis) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin ulceration -Lip lesion | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| High blood pressure (hypertension) | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Low blood pressure (hyportension) | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michaela Liedtke, MD | Stanford University Medical Center | 650-498-6000 | mliedtke@stanford.edu |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D004317 | Doxorubicin |
| C042705 | pegaspargase |
| D014750 | Vincristine |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D003561 | Cytarabine |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
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 |
|
| Participants |
|
|
|
|
|
| Participants |
|
|
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| Units | Counts |
|---|---|
| Participants |
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