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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01942 | Registry Identifier | NCI CTRP |
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The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of bendamustine, combined with fludarabine and rituximab, that can be given to patients who have CLL that has been treated before.
The goal of Phase 2 of this study is to find out if this drug combination can help to control the disease. The safety of this drug combination will also be studied.
The Study Drugs:
Fludarabine and bendamustine are designed to damage the DNA (genetic material) of cancer cells, which may cause the cancer cells to die.
Rituximab is designed to attach to cancer cells and damage them, which may cause the cancer cells to die. It is also designed to cause the immune system to attack cancer cells.
Study Drug Dose Levels:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. One (1) to 8 groups with 3-6 participants will be enrolled in the Phase 1 portion of the study, and up to 58 participants will be enrolled in Phase 2.
If you are enrolled in Phase 1, the dose of bendamustine you receive will depend on when you joined this study. The first group will receive the lowest dose. The next group will receive a higher dose, if the number and type of side effects was low or none. The dose of bendamustine will be increased for each new group until the highest tolerable dose is found.
If you are enrolled in Phase 2, you will receive bendamustine at the highest dose that was tolerated in Phase 1.
All participants in both phases of the study will start out with the same dose levels of fludarabine and rituximab.
If side effects occur, the study doctor may decide to lower your doses of study therapy. If you have side effects during a dose, the study staff will observe you for any other problems for 2 hours after the dose.
Study Drug Administration:
Cycles in this study are 4 weeks. All 3 study drugs are given by vein.
Cycle 1:
Cycles 2-6:
Other Drugs:
You will be given Tylenol (acetaminophen) and Benadryl (diphenhydramine hydrochloride) to take by mouth 30-60 minutes before every dose of rituximab (Cycles 1-6). These drugs are given to lower the risk of side effects.
Study Visits:
Once a week in Cycle 1 and every 2-4 weeks in Cycles 2-6, blood (about 1 tablespoon) will be drawn for routine tests.
Before Cycles 1-6, you will also have a physical exam, including measurement of your vital signs. You will be asked about any side effects you may have had.
Before Cycle 4, the following tests and procedures will be performed:
Length of Study Participation:
You may receive up to 6 cycles of study treatment. The study treatment will be stopped early if the disease gets worse or you experience any intolerable side effects.
End-of-Treatment Visit:
After Cycle 6 (or earlier if you stop early), the following tests and procedures will be performed:
Follow-Up Visits:
You will have follow-up visits at the end of Month 6 and Year 1 after your last dose of study drugs, and once a year until you start a new cancer treatment. The same tests will be performed as at the end-of-treatment visit. Starting at Year 3, the follow-up tests and procedures can be done by your local doctor if that is more convenient to you.
You should tell your study doctor or staff if you start another cancer treatment after the study. If that occurs, your follow-up in this study will stop.
This is an investigational study. Both fludarabine and bendamustine are commercially available and FDA approved to treat CLL. Rituximab is commercially available and FDA approved to treat lymphoma. The use of these drugs together in this study is investigational.
Up to 82 patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 20 mg/m^2 | Experimental | Bendamustine, Fludarabine + Rituximab |
|
| Phase 2 | Experimental | Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab |
|
| Phase 1 30 mg/m^2 | Experimental | Bendamustine, Fludarabine + Rituximab |
|
| Phase 1 40 mg/m^2 | Experimental | Bendamustine, Fludarabine + Rituximab |
|
| Phase 1 50 mg/m^2 | Experimental | Bendamustine, Fludarabine + Rituximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine | Drug | Phase 1: Starting Dose of 20 mg/m2 IV on Days 1,2,3 (after fludarabine) Phase 2: 30 mg/m2 by vein (fixed) on Days 1,2,3 (after fludarabine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR) | MTD defined as highest dose level in which 6 participants have been treated with </= to 1 patient experiencing dose limiting toxicity (DLT). MTD exceeded if 2 or more of 6 patients experience grade 3 or higher, non-hematologic, non-infusion related toxicity a major organ system. DLT defined as treatment-related, grade >/= 3 non-hematologic toxicity. Hematologic toxicity grade >/= 3 that lasts longer than 42 days considered a DLT. Hematologic toxicity graded according to the 2008 IWCLL criteria for grading. Tumor lysis not considered a DLT. | After 4 week cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR) | Overall Response is Complete response (CR) + Partial response (PR). Overall response evaluated by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for complete or partial response and progressive disease. Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; positive or negative minimal residual disease (MRD); Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William G. Wierda, MD, PhD, BS | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Recruitment Period: 4/2010 to 012/2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 20 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 20 mg/m^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 |
| FG001 | Phase 1 30 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 30 mg/m^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 |
| FG002 | Phase 1 40 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 40 mg/m^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 |
| FG003 | Phase 1 50 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 50 mg/m^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 |
| FG004 | Phase 2 | Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab Phase 2: 30 mg/m^2 by vein (fixed) on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 20 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 20 mg/m^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 |
| BG001 |
| 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 |
| 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 | Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR) | MTD defined as highest dose level in which 6 participants have been treated with </= to 1 patient experiencing dose limiting toxicity (DLT). MTD exceeded if 2 or more of 6 patients experience grade 3 or higher, non-hematologic, non-infusion related toxicity a major organ system. DLT defined as treatment-related, grade >/= 3 non-hematologic toxicity. Hematologic toxicity grade >/= 3 that lasts longer than 42 days considered a DLT. Hematologic toxicity graded according to the 2008 IWCLL criteria for grading. Tumor lysis not considered a DLT. | Maximum Tolerated Dose (MTD) was not established as an objective for the phase II portion of this study and was not collected. | Posted | Number | mg/m^2 | After 4 week cycle |
|
Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
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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 | Phase 1 20 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 20 mg/m^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amloidosis | General disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Wierda, MD./Professor | The University of Texas MD Anderson Cancer Center | 713-745-0428 | CR_Study_Registration@mdanderson.org |
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 | Aug 1, 2014 | Apr 6, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Fludarabine | Drug | Course 1: 20 mg/m2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m2 IV, Days 1,2,3 |
|
|
| Rituximab | Drug | Course 1: 375 mg/m2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m2 IV, Day 1 |
|
|
| Overall response assessed 2 months after 6th or last course if participants not able to receive all 6 intended courses of treatment. |
| Phase 1 30 mg/m^2 |
Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 30 mg/m^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 |
| BG002 | Phase 1 40 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 40 mg/m^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 |
| BG003 | Phase 1 50 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 50 mg/m^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 |
| BG004 | Phase 2 | Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab Phase 2: 30 mg/m^2 by vein (fixed) on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Overall Response Rate of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR) | Overall Response is Complete response (CR) + Partial response (PR). Overall response evaluated by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for complete or partial response and progressive disease. Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; positive or negative minimal residual disease (MRD); Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; | Two participants in the phase II portion of the study were not evaluable for response due to loss to follow-up. | Posted | Count of Participants | Participants | Overall response assessed 2 months after 6th or last course if participants not able to receive all 6 intended courses of treatment. |
|
|
|
| 2 |
| 6 |
| 4 |
| 6 |
| 6 |
| 6 |
| EG001 | Phase 1 30 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 30 mg/m^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Phase 1 40 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 40 mg/m^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 | 0 | 6 | 4 | 6 | 6 | 6 |
| EG003 | Phase 1 50 mg/m^2 | Bendamustine, Fludarabine + Rituximab Bendamustine: Phase 1: 50 mg/m^2 IV on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 | 0 | 6 | 5 | 6 | 6 | 6 |
| EG004 | Phase 2 | Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab Phase 2: 30 mg/m^2 by vein (fixed) on Days 1,2,3 (after fludarabine) Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3 Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1 | 1 | 30 | 16 | 30 | 30 | 30 |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Drug Rash | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Fainting | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fall | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemolysis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Nausea and Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenic Fever | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tumor Flare | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Tumor Lysis | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Acites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Allergic Reaction Investigational Product | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Bladder Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Elevated BUN | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Growth Neck | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage Bladder | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
|
| Subdural Hematoma | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tumor Lysis | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009588 |
| Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |