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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| RC0783 | Registry Identifier | Mayo Clinic Cancer Center | |
| 08-002080 | Other Identifier | Mayo Clinic IRB | |
| AVF4491s | Other Identifier | Genentech protocol | |
| NCI-2009-01225 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving pentostatin and cyclophosphamide together with rituximab is more effective with or without bevacizumab in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
PURPOSE: This randomized phase II trial is studying the side effects of giving pentostatin and cyclophosphamide together with rituximab with or without bevacizumab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to Rai risk group (high [Rai stage III or IV] vs low [Rai stage 0] or intermediate [Rai stage I or II]) and FISH prognosis group (favorable [normal, +12, 13q-, or other] vs unfavorable [17p- or 11q-]). Patients are randomized to 1 of 2 treatment arms.
NOTE: *Course 6 is 56 days in duration
NOTE: *Course 6 is 56 days in duration
Patients undergo blood sample collection and bone marrow biopsy/aspiration periodically for translational research studies. Samples are analyzed by flow cytometry for assessment of minimal residual disease. Molecular prognostic markers (including CD38, ZAP-70, IgVH gene mutation status, and cytogenetic abnormalities by FISH), Tcl-1 and CD49d protein expression, and immunoglobulin heavy chain D and J family gene usage are also analyzed. Plasma samples are stored for future studies evaluating levels of VEGF, bFGF, and thrombospondin by ELISA.
After completion of study therapy, patients are followed periodically for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin | Experimental | Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. |
|
| Arm B: Pentostatin, Cyclophosphamide, and Rituximab | Experimental | Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete and Overall Response Rate | A Complete Response (CR) requires all of the following for 2 months:
Nodular Partial Response (nPR) is defined as a patient qualified for a CR, but regenerative nodules are histologically present on bone marrow samples. A Clinical Complete Response (CCR) is defined as a patient qualified for a CR, but bone marrow samples are not available. A Partial Response (PR) requires 50% reduction in 2 of the following: peripheral blood lymphocytes, or the sum of the products of the maximal perpendicular diameters, or the size of liver and/or spleen; and a 50% increase in neutrophils, platelets, or hemoglobin. Overall response rate is calculated as the number of patients receiving CR, CCR, nPR, or PR as their objective status divided by the total number of evaluable patients. | Evaluated after 6 cycles (up to 196 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The Kaplan-Meier method will be used to estimate overall survival distributions Overall survival is measured as the time from registration to the time of death due to any cause. | Assessed up to 5 years from registration |
| Progression-free Survival |
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Biopsy proven small lymphocytic lymphoma (SLL)
Chronic lymphocytic leukemia (CLL)* as evidenced by the following criteria:
Peripheral blood lymphocyte count > 5,000/mm³ consisting of small to moderate size lymphocytes
Immunophenotyping consistent with CLL, defined by the following:
Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy samples NOTE: *Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
Has ≥ 1 of the following indications** for chemotherapy:
Evidence of progressive marrow failure as manifested by the development of or worsening anemia (hemoglobin ≤ 11 g/dL) and/or thrombocytopenia (platelet count ≤ 100,000/mm³)
Symptomatic or progressive lymphadenopathy, splenomegaly or hepatomegaly
Has ≥ 1 of the following disease-related symptoms:
Progressive lymphocytosis (not due to the effects of corticosteroids) with an increase of > 50% over a 2-month period or an anticipated doubling time of < 6 months NOTE: **Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not sufficient indications for study treatment
PATIENT CHARACTERISTICS:
Eastern Cooperative Oncology Group performance status 0-3
Life expectancy ≥ 12 months
Total bilirubin ≤ 3.0 times upper limit of normal (ULN) (unless due to Gilbert's disease)
Serum glutamate oxaloacetate transaminase ≤ 3.0 times ULN (unless due to hepatic involvement by CLL)
Creatinine ≤ 1.5 times ULN
Urine protein:creatinine ratio < 1.0 OR < 1 g of protein by 24-hour urine collection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 12 months after completion of study treatment
Willing to provide mandatory blood and tissue samples
None of the following cardiovascular conditions:
NYHA class III-IV heart disease
Myocardial infarction within the past 6 months
Unstable angina
Stroke, cerebrovascular accident, or transient ischemic attack within the past 6 months
Arterial thromboembolic events within the past 12 months
Clinically significant peripheral vascular disease
Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg
History of hypertensive crises or hypertensive encephalopathy
Deep venous thromboses or pulmonary embolism within the past 12 months
No evidence of bleeding diathesis or coagulopathy
No uncontrolled or active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment
No active or recent history (within the past 30 days) of hemoptysis (≥ ½ teaspoon of bright red blood per episode)
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
No active peptic ulcer disease
No serious non-healing wound, ulcer, or bone fracture
No significant traumatic injury within the past 28 days
No uncontrolled infection
No active HIV infection
No other active primary malignancy (except nonmelanoma skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting survival to ≤ 2 years
No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude study participation
PRIOR CONCURRENT THERAPY:
Prior corticosteroids allowed
More than 4 weeks since prior radiotherapy
More than 28 days since prior and no concurrent major surgical procedure or open biopsy
More than 7 days since prior minor surgical procedure, fine needle aspiration, or core biopsy (other than bone marrow biopsy)
No concurrent therapeutic doses of coumadin-derivative anticoagulants (e.g., warfarin)
No other concurrent investigational agents for treatment of CLL or SLL
No other concurrent specific anticancer treatment except hormonal therapy
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| Name | Affiliation | Role |
|---|---|---|
| Tait D. Shanafelt, MD | Mayo Clinic | Study Chair |
| Jose F. Francisco, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin | Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| pegfilgrastim | Biological | Given subcutaneously |
|
| rituximab | Biological | Given IV |
|
| cyclophosphamide | Drug | Given IV |
|
| pentostatin | Drug | Given IV |
|
The Kaplan-Meier method will be used to estimate progression-free survival distribution. Progression-free survival is defined as the time from registration to the time of progression or death, whichever occurs first. |
| Assessed up to 5 years from registration |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| FG001 | Arm B: Pentostatin, Cyclophosphamide, and Rituximab | Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin | Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. |
| BG001 | Arm B: Pentostatin, Cyclophosphamide, and Rituximab | Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| 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 | Complete and Overall Response Rate | A Complete Response (CR) requires all of the following for 2 months:
Nodular Partial Response (nPR) is defined as a patient qualified for a CR, but regenerative nodules are histologically present on bone marrow samples. A Clinical Complete Response (CCR) is defined as a patient qualified for a CR, but bone marrow samples are not available. A Partial Response (PR) requires 50% reduction in 2 of the following: peripheral blood lymphocytes, or the sum of the products of the maximal perpendicular diameters, or the size of liver and/or spleen; and a 50% increase in neutrophils, platelets, or hemoglobin. Overall response rate is calculated as the number of patients receiving CR, CCR, nPR, or PR as their objective status divided by the total number of evaluable patients. | One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients. | Posted | Number | percentage of patients | Evaluated after 6 cycles (up to 196 days) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | The Kaplan-Meier method will be used to estimate overall survival distributions Overall survival is measured as the time from registration to the time of death due to any cause. | One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients. | Posted | Median | 95% Confidence Interval | months | Assessed up to 5 years from registration |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | The Kaplan-Meier method will be used to estimate progression-free survival distribution. Progression-free survival is defined as the time from registration to the time of progression or death, whichever occurs first. | One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients. | Posted | Median | 95% Confidence Interval | months | Assessed up to 5 years from registration |
|
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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 A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin | Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV | 11 | 33 | 32 | 33 | ||
| EG001 | Arm B: Pentostatin, Cyclophosphamide, and Rituximab | Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV | 5 | 33 | 30 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Localized edema | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
| |
| Bladder hemorrhage | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Protein urine positive | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Vascular disorder | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 10 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Restrictive cardiomyopathy | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Torsade de pointes | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 10 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 10 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 10 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 10 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 10 | Systematic Assessment |
| |
| Immune system disorder | Immune system disorders | MedDRA 10 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Gallbladder infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Upper aerodigestive tract infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 10 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Serum sodium increased | Metabolism and nutrition disorders | MedDRA 10 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 10 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10 | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Hemorrhage urinary tract | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Protein urine positive | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 10 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 10 | Systematic Assessment |
| |
| Vascular disorder | Vascular disorders | MedDRA 10 | Systematic Assessment |
|
Not provided
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tait Shanafelt, M.D. | Mayo Clinic | shanafelt.tait@mayo.edu |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| 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 |
| 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 |
|---|---|
| D000068258 | Bevacizumab |
| C455861 | pegfilgrastim |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D015649 | Pentostatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| 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 |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003070 | Coformycin |
| D005573 | Formycins |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
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Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV |
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