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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01690 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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The goal of this clinical research study is to learn if Revlimid (lenalidomide) can help to reduce the level of leukemia in your body. The safety of this drug will also be studied.
The Study Drug:
Lenalidomide is designed to change the body's immune system and may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take lenalidomide by mouth every night each day for up to 12 months. You should swallow lenalidomide capsules whole, with water, at the same time each day. Do not break, chew, or open the capsules. If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss a dose, it should not be made up on another day.
The dose and schedule of lenalidomide may be changed, depending on the side effects you may experience.
Study Visits:
Once a week during the first 4 weeks, blood (about 1 tablespoon) will be drawn for routine tests. Blood may be drawn more often if the dose of lenalidomide needs to be changed or if you experience side effects.
After the first 4 weeks, blood (about 1 tablespoon) will be drawn for routine tests every 2 weeks until the doctor thinks your dose of lenalidomide will not change. After this, blood (about 1 tablespoon) will then be drawn every 4 weeks for routine tests.
On Month 4 and 12 (+14 days), you will have a physical exam and blood (about 2-3 teaspoons) will be drawn to check the status of the disease.
On Month 4 and 12 (+14 days), and then every 3 months after that (unless your study doctor does not think it is necessary), you will have a bone marrow biopsy and aspirate to check the status of the disease.
Length of Study:
You will continue receiving the study drug for up to 12 months. You will continue having study visits for as long as the disease remains stable. You will be taken off study early if the disease gets worse or intolerable side effects occur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomide | Experimental | Lenalidomide 10 mg daily given for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | 10 mg daily given for 12 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Quality of Remission: Number of Participants With Response Versus No Response by NCI Working Group Criteria Disease Status Change at Start/End of Lenalidomide Consolidation | To evaluate ability of lenalidomide to improve quality of remission (e.g. from partial remission (PR) to complete remission (CR)), disease status assessed at start & end of Lenalidomide consolidation. NCI Working Group Response Criteria: Participants who began therapy in PR, improvement of status to nodular partial remission (nPR) or CR; Participants in nPR (otherwise CR, bone marrow nodules identified histologically), improvement of status to CR. Participants in CR, resolution of measurable disease in blood &/or bone marrow per immuno flow cytometry or PCR testing. Progressive Disease (PD): One or more of following: >50% increase in sum of products of =/>2 lymph nodes on 2 consecutive examinations; One+ node must be >2 cm or appearance of new enlarged lymph nodes; >50% increase in liver &/or spleen as determined by physical examination/appearance of splenomegaly not previously present; >50% increase in circulating lymphocytes with absolute count >10,000. | Baseline to 12 Months, Disease status assessed at Start/End of Lenalidomide Consolidation |
| Response Assessments: Disease Status at the End of Lenalidomide Consolidation Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria | 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; Nodular Partial Remission (nPR) is CR with bone marrow nodules identified histologically. Progressive disease (PD), defined as ≥ 50% rise in lymphocyte count to > 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, PR or PD. | 12 Months, Disease status assessed at the End of Lenalidomide Consolidation |
| Time to Progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandra Ferrajoli, M.D, | M.D. Anderson Cancer Center | Principal Investigator |
| 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: February 28, 2008 to January 7, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lenalidomide | Lenalidomide 10 mg daily given for 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lenalidomide | Lenalidomide 10 mg daily given for 12 months. |
| 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 | Improvement in Quality of Remission: Number of Participants With Response Versus No Response by NCI Working Group Criteria Disease Status Change at Start/End of Lenalidomide Consolidation | To evaluate ability of lenalidomide to improve quality of remission (e.g. from partial remission (PR) to complete remission (CR)), disease status assessed at start & end of Lenalidomide consolidation. NCI Working Group Response Criteria: Participants who began therapy in PR, improvement of status to nodular partial remission (nPR) or CR; Participants in nPR (otherwise CR, bone marrow nodules identified histologically), improvement of status to CR. Participants in CR, resolution of measurable disease in blood &/or bone marrow per immuno flow cytometry or PCR testing. Progressive Disease (PD): One or more of following: >50% increase in sum of products of =/>2 lymph nodes on 2 consecutive examinations; One+ node must be >2 cm or appearance of new enlarged lymph nodes; >50% increase in liver &/or spleen as determined by physical examination/appearance of splenomegaly not previously present; >50% increase in circulating lymphocytes with absolute count >10,000. | Of the three participants registered, two were not evaluable for response. | Posted | Number | participants | Baseline to 12 Months, Disease status assessed at Start/End of Lenalidomide Consolidation |
Adverse event collection for 12 months 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 | Lenalidomide | Lenalidomide 10 mg daily given for 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALKALINE PHOSPHATASE INCREASE | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alessandra Ferrajoli, Professor, Leukemia | The University of Texas (UT) MD Anderson Cancer Center | 713-792-7734 | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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Time from the start of study drug therapy to the first documentation of disease progression. Progressive disease characterized by at least one of the following: >50% increase in the sum of products of at least 2 lymph nodes on 2 consecutive examinations. At least one node larger than 2 cm. Or, appearance of new enlarged lymph nodes. >50% increase in size of liver and/or spleen as determined by physical examination or appearance of splenomegaly which was not previously present. >50% increase in number of circulating lymphocytes with absolute count of at least 10,000. |
| From baseline to 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Response Assessments: Disease Status at the End of Lenalidomide Consolidation Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria | 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; Nodular Partial Remission (nPR) is CR with bone marrow nodules identified histologically. Progressive disease (PD), defined as ≥ 50% rise in lymphocyte count to > 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, PR or PD. | Of the 33 participants who were treated, two Participants were not evaluable. | Posted | Number | participants | 12 Months, Disease status assessed at the End of Lenalidomide Consolidation |
|
|
|
| Primary | Time to Progression | Time from the start of study drug therapy to the first documentation of disease progression. Progressive disease characterized by at least one of the following: >50% increase in the sum of products of at least 2 lymph nodes on 2 consecutive examinations. At least one node larger than 2 cm. Or, appearance of new enlarged lymph nodes. >50% increase in size of liver and/or spleen as determined by physical examination or appearance of splenomegaly which was not previously present. >50% increase in number of circulating lymphocytes with absolute count of at least 10,000. | Of the 33 participants treated, two were not evaluable for outcome assessment due to early departure from study. | Posted | Mean | 95% Confidence Interval | Months | From baseline to 12 months |
|
|
|
| 8 |
| 33 |
| 27 |
| 33 |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | THROMBOSIS/THROMBUS/EMBOLISM |
|
| Pulmonary Embolus | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infections, Respiratory syncytial virus (RSV) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| THROMBOSIS/THROMBUS/EMBOLISM | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alanine aminotransferase Increased (ALT, SGPT) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased (AST, SGOT) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| AUDITORY/EAR (OTHER) | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| BILIRUBIN INCREASED | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| CARDIAC ISCHEMIA/INFARCTION | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| CREATININE INCREASED | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| DERMATOLOGY/SKIN (OTHER) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| DIABETES (Hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| DISTENSION/BLOATING | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| ENDOCRINE (OTHER: adrenal difference) | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| ERYTHEMA MULTIFORME | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| FATIGUE | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| FLU-LIKE SYNDROME | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL (OTHER) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| HEARING CHANGE (WITHOUT MONITORING) | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| HEMOGLOBIN INCREASED | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| HEMORRHAGE, Genitourinary | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| HEMORRHAGE, PULMONARY (NOSE) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| HOT FLASHES | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| HYPERGLYCEMIA | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| HYPERNATREMIA | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| HYPERTENSION | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| HYPERURICEMIA | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| HYPOALBUMINEMIA | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| HYPOCALCEMIA | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| HYPOMAGNESEMIA | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| HYPONATREMIA | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| INFECTION | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| MAGNESIUM, SERUM-HIGH | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY (OTHER) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| MOOD ALTERATION (AGITATION) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| MOOD ALTERATION (ANXIETY) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| MOOD ALTERATION (DEPRESSION) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| MOTOR SKILLS, AFFECTED | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| NEUROPATHY: SENSORY | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils, AGC (absolute granulocyte counts) Increased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| OBSTRUCTION, GU (BLADDER) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| OCULAR/VISUAL (OTHER) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| PHLEBITIS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| PULMONARY (OTHER) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| RENAL/GENITOURINARY (OTHER) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| RESPIRATORY SYMPTOMS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| RIGORS/CHILLS | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| SWEATING | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| THROMBOSIS/THROMBUS/EMBOLISM | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| TINNITUS | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| TUMOR FLARE REACTION | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| VOICE CHANGES | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| FEVER | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| INFECTION | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
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| 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 |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|
| PD |
|