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| ID | Type | Description | Link |
|---|---|---|---|
| RV-CLL/SLL-PI-397 | |||
| A534260 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\HEM-ONC | Other Identifier | UW Madison | |
| H-2009-0087 | Other Identifier | Institutional Review Board | |
| NCI-2011-00646 | Registry Identifier | NCI Trial ID |
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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill).
The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction/Maintenance chemotherapy | Experimental | Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine | Drug | 90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007). | 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) |
| Progression-free Survival | Progression-free survival (PFS) is defined as the time from the day of first study drug administration until progression of CLL/SLL or death from any cause. PFS is reported as the proportion of participants with PFS up to 42 months. | 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (Complete + Partial Responses) | Response and progression in cases of SLL were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of CLL were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007). Complete response defined as resolution enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/SLL detectable in the bone marrow. Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count. Progressive disease defined as 50% or more increase in the combined measurements of at least 2 lymph nodes as measured on CT scans or the appearance of new enlarged lymph nodes; 50% of more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Chang, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent Regional Cancer Center | Green Bay | Wisconsin | 54301 | United States | ||
| Bellin Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38856101 | Derived | Chang JE, Wang T, Kim K, Folstad M, Endres M, Howard M, Kenkre V, Fletcher C, Rajguru S. Maintenance low-dose fixed duration lenalidomide and rituximab following bendamustine and rituximab induction in previously untreated chronic lymphocytic leukemia and small lymphocytic lymphoma. Leuk Lymphoma. 2024 Oct;65(10):1456-1464. doi: 10.1080/10428194.2024.2360535. Epub 2024 Jun 10. |
| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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Research subjected from the University of Wisconsin and 7 Wisconsin Oncology Network institutions were enrolled from October 2009 to November 2011. Subjects were enrolled from outpatient hematology clinics at each participating institution.
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| ID | Title | Description |
|---|---|---|
| FG000 | Induction Chemoimmunotherapy + Maintenance Lenalidomide | Induction therapy: Bendamustine 90 mg/m2 IV on days 1 & 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles. Maintenance therapy: Lenalidomide 5-10 mg orally continuously of each 28-day cycles for total of 12 treatment cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Chemoimmunotherapy |
|
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| Rituximab | Drug | 375 mg/m2 Day 1 every 28 days for 6 cycles |
|
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| Lenalidomide | Drug | 5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol. |
|
|
| 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) |
| Toxicities Observed With Induction Chemotherapy and Maintenance Therapy | Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0. | 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) |
| Overall Survival | Overall survival (OS) is defined as the time from the day of first study drug administration until death from any cause. | 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) |
| Green Bay |
| Wisconsin |
| 54313 |
| United States |
| Mercy Health System Heme/Onc | Janesville | Wisconsin | 53548 | United States |
| Gundersen Clinic | La Crosse | Wisconsin | 54601 | United States |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | 53066 | United States |
| Waukesha Memorial Hospital | Waukesha | Wisconsin | 53188 | United States |
| Riverview Hospital | Wisconsin Rapids | Wisconsin | 54494 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| Maintenance Lenalidomide |
|
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Subjects with progressive chronic lymphocytic leukemia/small lymphocytic lymphoma receiving 1-5 prior unique treatment regimens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | Patient population with chronic lymphocytic leukemia/small lymphocytic lymphoma with progressive disease in need of therapy after at least 1 prior chemotherapy regimen, but no more than 5 prior unique chemotherapy regimens (retreatment with identical regimen did not count as a unique regimen). |
| 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 |
| |||||||||||||||||||||||
| ECOG performance status | ECOG performance status (PS) evaluated clinically in all patients on a scale from 0-5, with higher ECOG PS indicating worse functional impairment (i.e., ECOG PS of zero = asymptomatic, fully functional patient; ECOG PS of 5 = death). | Number | participants |
| ||||||||||||||||||||||
| Disease staging | Rai staging is a clinical evaluation taking into account blood counts and physical exam findings, with staging ranging from 0-4 (more advanced staging corresponding with higher numbers). Ann Arbor staging is an evaluation of physical exam finding combined with imaging evaluation (usually CT imaging) to determine extent of lymph node enlargement, with staging ranging from 1-4 (more advanced staging corresponding with higher numbers). | Number | participants |
| ||||||||||||||||||||||
| Median prior therapies | Describes number of unique prior therapies received by subjects, including monoclonal antibody therapy (i.e., single-agent rituximab) or cytotoxic chemotherapy-based therapies. Retreatment with an identical regimen was not counted as a unique therapy. Subjects required at least one cytotoxic chemotherapy-based therapy for eligibility. | Median | Full Range | prior therapies |
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| Prior therapy with fludarabine | Number | participants |
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| Refractory to most recent therapy | Number | participants |
| |||||||||||||||||||||||
| Elevated serum lactate dehydrogenase (LDH) level | Lactate dehydrogenase (LDH) is associated with cell growth and turnover in the body. Higher levels of LDH tend to be associated with more rapid tumor growth and is a marker of higher risk lymphoma/leukemia. | Number | participants |
| ||||||||||||||||||||||
| Baseline cytogenetics | Number | participants |
| |||||||||||||||||||||||
| Prior therapy with rituximab | Number | participants |
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| 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 | Progression Free Survival | The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007). | The study was designed to test the null hypothesis that the median PFS with induction BR and maintenance lenalidomide is at most 18 months versus the alternative hypothesis that median PFS is >18 months, at a one-sided significance level of 0.10 with a power of 80%. | Posted | Median | 95% Confidence Interval | months | 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) |
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| |||||||||||||||||||||||||
| Primary | Progression-free Survival | Progression-free survival (PFS) is defined as the time from the day of first study drug administration until progression of CLL/SLL or death from any cause. PFS is reported as the proportion of participants with PFS up to 42 months. | Posted | Median | 95% Confidence Interval | Proportion of participants | 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) |
|
| |||||||||||||||||||||||||||
| Secondary | Objective Response Rate (Complete + Partial Responses) | Response and progression in cases of SLL were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of CLL were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007). Complete response defined as resolution enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/SLL detectable in the bone marrow. Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count. Progressive disease defined as 50% or more increase in the combined measurements of at least 2 lymph nodes as measured on CT scans or the appearance of new enlarged lymph nodes; 50% of more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count. | Posted | Number | participants | 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) |
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| Secondary | Toxicities Observed With Induction Chemotherapy and Maintenance Therapy | Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0. | Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0. | Posted | Number | participants | 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) |
|
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| Secondary | Overall Survival | Overall survival (OS) is defined as the time from the day of first study drug administration until death from any cause. | Overall survival (OS) was measured for all enrolled subjects as the time from the day of first study drug administration until death from any cause. | Posted | Median | 95% Confidence Interval | months | 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) |
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Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
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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 | Induction Chemoimmunotherapy | Bendamustine 90 mg/m2 IV on days 1 & 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles. | 14 | 34 | 34 | 34 | ||
| EG001 | Maintenance | Lenalidomide 5-10 mg administered orally daily as continuous therapy for up to 12 treatment cycles (28-day treatment cycles) in patients without disease progression or treatment-related toxicities that would prohibit ongoing treatment. | 8 | 19 | 19 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 4 neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | SAEs included any grade 2-3 unexpected event with at least probable attribution, grade 4-5 toxicity regardless of attribution. Number of events includes worst grade toxicity per patient. |
|
| Grade 3 neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Includes all events of grade 3 neutropenia, regardless of whether or not resulted in hospitalization of other definition of SAE. |
|
| Grade 4 thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Includes all events of grade 4 thrombocytopenia, as required by definition of SAE per protocol. |
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| Grade 3 thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Includes all events of grade 3 thrombocytopenia, regardless of whether or not resulted in hospitalization of other definition of SAE. |
|
| Grade 4 leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Includes all events of grade 4 leukopenia, as defined by SAE reporting per protocol. |
|
| Grade 3 leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Includes all events of grade 3 leukopenia, regardless of whether or not resulted in hospitalization of other definition of SAE. |
|
| Grade 4 febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Grade 3 febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Grade 5 infections | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Grade 4 infections | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Grade 3 tumor lysis syndrome | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Grade 3 thrombosis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Second primary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | Includes events that occurred during treatment and during long-term follow-up phase of treatment. |
|
| Grade 3 prolonged QTc interval | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Grade 5 heart failure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 3 Infections | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 3 fatigue | General disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
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| Grade 1-2 fatigue | General disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 3 emesis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
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| Grade 1-2 nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 3 diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 3 hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 3 elevated AST/ALT | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 1-2 AST/ALT | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 1-2 night sweats | General disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 1-2 rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 1-2 cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 1-2 headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Grade 1-2 musculoskeletal pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 3 pain NOS | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 1-2 hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 1-2 emesis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
| Grade 2 stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie E. Chang, MD | University of Wisconsin | 608-262-3970 | jc2@medicine.wisc.edu |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| 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 |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| 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 |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D054833 | Isoindoles |
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|
| Ann Arbor stage 1/2 (SLL) |
|
| Ann Arbor 3/4 (SLL) |
|
| Trisomy 12 |
|
| Normal |
|
| Unknown |
|
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| OG002 | Stable Disease | Stable disease includes cases where there has been objective improvement in blood counts and lymph node size, but does not meet criteria for either a complete or partial response. |
| OG003 | Overall Response Rate | Includes complete and partial responses. |
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