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| ID | Type | Description | Link |
|---|---|---|---|
| 2P50CA171963-06 | U.S. NIH Grant/Contract | View source |
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Not provided
Low accrual
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| Name | Class |
|---|---|
| The Leukemia and Lymphoma Society | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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The outcome of patients with relapsed or refractory adult T-acute lymphoblastic leukemia (T-ALL) and the related disease T-lymphoblastic lymphoma (T-LBL) is extremely poor with 30% of the patients responding to first salvage therapy and long-term survival of only 10%. Therefore, novel therapies for patients with relapsed/refractory T-ALL/LBL represent an unmet clinical need.
Recent data provide strong evidence that CXCR4 signaling plays a major role in T-cell leukemia cell maintenance and leukemia initiating activity, and targeting CXCR4 signaling in T-ALL cells reduces tumor growth in an animal model. In this study, the investigators propose that the addition of BL-8040 to nelarabine as a salvage therapy for patients with relapsed/refractory T-ALL/LBL will result in a higher complete remission (CR) rate than nelarabine alone without an increase in toxicity and will allow patients to proceed to a potentially curative allogeneic hematopoietic cell transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BL-8040 and Nelarabine | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL-8040 | Drug |
| ||
| Nelarabine |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event reporting. | Up to 30 days after completion of treatment (median follow-up of 51.5 days, full range 24-120 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Complete Remission Rate (CRc=CR+CRi) | Complete remission (CR) = an absolute neutrophil count (segs and bands) > 1,000/mcL, no circulating lymphoblasts, platelets ≥ 100,000/mcL; and < 5% marrow leukemia blast cells with complete disappearance of all measurable disease as confirmed by physical examination, CT scan and/or FDG-PET (Deauville criteria score of 1, 2, or 3) -Morphologic complete remission with incomplete blood count recovery (CRi)=Defined as CR with the exception of neutropenia < 1,000/mcL or thrombocytopenia <100,000/mcL |
| Measure | Description | Time Frame |
|---|---|---|
| Interaction of Pretreatment Disease and White Blood Cell Count on Clinical Outcome | Interaction of pretreatment disease and white blood cell count on clinical outcome | Up to 2 years after completion of treatment (approximately 116 weeks) |
| Interaction of Pretreatment Disease and Performance Status on Clinical Outcome |
Inclusion Criteria:
Diagnosis of T-acute lymphoblastic leukemia/ lymphoblastic lymphoma according to WHO criteria which has relapsed or is refractory to chemotherapy.
Peripheral blood lymphoblasts ≤ 50,000 mcL. Hydroxyurea and/or leukapheresis is permitted to reduce the peripheral blast count prior to enrollment and treatment.
Age ≥ 18 years
ECOG performance status ≤ 2.
Adequate organ function defined as:
Women of childbearing potential and men must agree to use adequate contraception with a highly effective method (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Abstinence is acceptable if this is the established and preferred contraception for the subject.
Female subjects must have a negative urine or serum pregnancy test within 72 hours prior to start of study treatment if of childbearing potential or be of non-childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the subject to be eligible. Non-childbearing potential is defined as:
*≥ 45 years of age and has not had menses for > 2 years
Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey L Uy, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States | ||
| The University of Texas MD Anderson Cancer Center |
Not provided
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: BL-8040 and Nelarabine |
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: BL-8040 and Nelarabine |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events | The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event reporting. | Posted | Count of Participants | Participants | Up to 30 days after completion of treatment (median follow-up of 51.5 days, full range 24-120 days) |
|
Adverse events were collected from first dose of study treatment through 30 days after the last study treatment (maximum of 4 cycles of treatment - each cycle is 21 days). All-cause mortality was collected from first dose of study treatment through completion of follow-up (maximum of 2 years following completion of treatment).
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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 | Arm 1: BL-8040 and Nelarabine |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy worsening | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Geoffrey L. Uy, M.D. | Washington University School of Medicine | 314-747-8439 | guy@wustl.edu |
Not provided
| 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 | Jan 17, 2023 | Oct 2, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C477728 | 4-fluorobenzoyl-TN-14003 |
| C104457 | nelarabine |
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|
|
| Completion of treatment (approximately 12 weeks) |
| Overall Response Rate (CR, CRi + PR) |
| Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days) |
| Time to Response |
| Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days) |
| Duration of Response | Defined as the interval from the date CR/CRi is documented to the date of recurrence or completion of follow-up if recurrence has not occurred. | Through date of recurrence or completion of follow-up (maximum of 2 years after completion of treatment) |
| Event-free Survival (EFS) | EFS is defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, of death due to any cause. | Through completion of follow-up (maximum of 2 years after completion of treatment) |
| Overall Survival | Defined as the date of first dose of study drug to the date of death from any cause. | Through completion of follow-up (maximum of 2 years after completion of treatment) |
| Rate of Patients Who Proceed to alloHCT After Treatment | Estimate rate of patients who proceed to alloHCT after treatment | Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days) |
Interaction of pretreatment disease and performance status on clinical outcome |
| Up to 2 years after completion of treatment (approximately 116 weeks) |
| Interaction of Pretreatment Disease and Immunophenotype on Clinical Outcome | Interaction of pretreatment disease and immunophenotype on clinical outcome | Up to 2 years after completion of treatment (approximately 116 weeks) |
| Interaction of Pretreatment Disease and Cytogenetics on Clinical Outcome | Interaction of pretreatment disease and cytogenetics on clinical outcome | Up to 2 years after completion of treatment (approximately 116 weeks) |
| Interaction of Pretreatment Disease and CXCR4 Expression on Lymphoblasts on Clinical Outcome | Interaction of pretreatment disease and CXCR4 expression on lymphoblasts on clinical outcome | Up to 2 years after completion of treatment (approximately 116 weeks) |
| Interaction of Pretreatment Disease and Morphology on Clinical Outcome | Interaction of pretreatment disease and morphology on clinical outcome | Up to 2 years after completion of treatment (approximately 116 weeks) |
| Pharmacodynamic Effects of BL-8040 on T-lymphoblasts as Measured by Alterations in Lymphoblast Cell Cycle Status | Pharmacodynamic effects of BL-8040 on T-lymphoblasts as measured by alterations in lymphoblast cell cycle status | Completion of treatment (approximately 12 weeks) |
| Pharmacodynamic Effects of BL-8040 on T-lymphoblasts as Measured by Induction of Apoptosis in Lymphoblasts | Pharmacodynamic effects of BL-8040 on T-lymphoblasts as measured by induction of apoptosis in lymphoblasts | Completion of treatment (approximately 12 weeks) |
| Pharmacodynamic Effects of BL-8040 on T-lymphoblasts as Measured by Mobilization of Lymphoblasts Into the Peripheral Circulation | Pharmacodynamic effects of BL-8040 on T-lymphoblasts as measured by mobilization of lymphoblasts into the peripheral circulation | Completion of treatment (approximately 12 weeks) |
| Pharmacodynamic Effects of BL-8040 on T-lymphoblasts as Measured by Inhibition of CXCR4 Signaling on Lymphoblasts | Pharmacodynamic effects of BL-8040 on T-lymphoblasts as measured by inhibition of CXCR4 signaling on lymphoblasts | Completion of treatment (approximately 12 weeks) |
| Houston |
| Texas |
| 77030 |
| United States |
| 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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Composite Complete Remission Rate (CRc=CR+CRi) | Complete remission (CR) = an absolute neutrophil count (segs and bands) > 1,000/mcL, no circulating lymphoblasts, platelets ≥ 100,000/mcL; and < 5% marrow leukemia blast cells with complete disappearance of all measurable disease as confirmed by physical examination, CT scan and/or FDG-PET (Deauville criteria score of 1, 2, or 3) -Morphologic complete remission with incomplete blood count recovery (CRi)=Defined as CR with the exception of neutropenia < 1,000/mcL or thrombocytopenia <100,000/mcL | 2 participants were not evaluable for this outcome measure because they stopped treatment prior to disease response assessment. | Posted | Count of Participants | Participants | Completion of treatment (approximately 12 weeks) |
|
|
|
| Secondary | Overall Response Rate (CR, CRi + PR) |
| 2 participants were not evaluable for this outcome measure because they stopped treatment prior to disease response assessment. | Posted | Count of Participants | Participants | Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days) |
|
|
|
| Secondary | Time to Response |
| Posted | Median | Full Range | days | Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days) |
|
|
|
| Secondary | Duration of Response | Defined as the interval from the date CR/CRi is documented to the date of recurrence or completion of follow-up if recurrence has not occurred. | Posted | Median | Full Range | days | Through date of recurrence or completion of follow-up (maximum of 2 years after completion of treatment) |
|
|
|
| Secondary | Event-free Survival (EFS) | EFS is defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, of death due to any cause. | Posted | Median | Full Range | days | Through completion of follow-up (maximum of 2 years after completion of treatment) |
|
|
|
| Secondary | Overall Survival | Defined as the date of first dose of study drug to the date of death from any cause. | Posted | Median | Full Range | days | Through completion of follow-up (maximum of 2 years after completion of treatment) |
|
|
|
| Secondary | Rate of Patients Who Proceed to alloHCT After Treatment | Estimate rate of patients who proceed to alloHCT after treatment | Posted | Count of Participants | Participants | Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days) |
|
|
|
| Other Pre-specified | Interaction of Pretreatment Disease and White Blood Cell Count on Clinical Outcome | Interaction of pretreatment disease and white blood cell count on clinical outcome | Not Posted | Up to 2 years after completion of treatment (approximately 116 weeks) | Participants |
| Other Pre-specified | Interaction of Pretreatment Disease and Performance Status on Clinical Outcome | Interaction of pretreatment disease and performance status on clinical outcome | Not Posted | Up to 2 years after completion of treatment (approximately 116 weeks) | Participants |
| Other Pre-specified | Interaction of Pretreatment Disease and Immunophenotype on Clinical Outcome | Interaction of pretreatment disease and immunophenotype on clinical outcome | Not Posted | Up to 2 years after completion of treatment (approximately 116 weeks) | Participants |
| Other Pre-specified | Interaction of Pretreatment Disease and Cytogenetics on Clinical Outcome | Interaction of pretreatment disease and cytogenetics on clinical outcome | Not Posted | Up to 2 years after completion of treatment (approximately 116 weeks) | Participants |
| Other Pre-specified | Interaction of Pretreatment Disease and CXCR4 Expression on Lymphoblasts on Clinical Outcome | Interaction of pretreatment disease and CXCR4 expression on lymphoblasts on clinical outcome | Not Posted | Up to 2 years after completion of treatment (approximately 116 weeks) | Participants |
| Other Pre-specified | Interaction of Pretreatment Disease and Morphology on Clinical Outcome | Interaction of pretreatment disease and morphology on clinical outcome | Not Posted | Up to 2 years after completion of treatment (approximately 116 weeks) | Participants |
| Other Pre-specified | Pharmacodynamic Effects of BL-8040 on T-lymphoblasts as Measured by Alterations in Lymphoblast Cell Cycle Status | Pharmacodynamic effects of BL-8040 on T-lymphoblasts as measured by alterations in lymphoblast cell cycle status | Not Posted | Completion of treatment (approximately 12 weeks) | Participants |
| Other Pre-specified | Pharmacodynamic Effects of BL-8040 on T-lymphoblasts as Measured by Induction of Apoptosis in Lymphoblasts | Pharmacodynamic effects of BL-8040 on T-lymphoblasts as measured by induction of apoptosis in lymphoblasts | Not Posted | Completion of treatment (approximately 12 weeks) | Participants |
| Other Pre-specified | Pharmacodynamic Effects of BL-8040 on T-lymphoblasts as Measured by Mobilization of Lymphoblasts Into the Peripheral Circulation | Pharmacodynamic effects of BL-8040 on T-lymphoblasts as measured by mobilization of lymphoblasts into the peripheral circulation | Not Posted | Completion of treatment (approximately 12 weeks) | Participants |
| Other Pre-specified | Pharmacodynamic Effects of BL-8040 on T-lymphoblasts as Measured by Inhibition of CXCR4 Signaling on Lymphoblasts | Pharmacodynamic effects of BL-8040 on T-lymphoblasts as measured by inhibition of CXCR4 signaling on lymphoblasts | Not Posted | Completion of treatment (approximately 12 weeks) | Participants |
| 9 |
| 12 |
| 8 |
| 12 |
| 12 |
| 12 |
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Pain at BL-8040 injection site | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Altered mental status | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infarct | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diffuse pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Injection site reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Injection site reaction (rash) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Localized edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain at CVC site | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in leg | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Transfusion reaction to pRBC | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| "Feeling funny" post transfusion | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Biopsy pain | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Catheter pain, replacement | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Pain at right internal jugular Hohn catheter | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Pain, skin nodule at biopsy site | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Redness at Hohn catheter insertion site | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac troponin T increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| INR increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Serum amylase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell count increased post BL-8040 injection | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Right knee pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Altered mental status | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Irregular menstruation | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cellulitis on hand | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Scalp pain | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |