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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00560 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This is a Phase II, single institution open-label, non-randomized monotherapy study to evaluate the clinical efficacy and durable disease control of PCI-32765 administered to patients with relapsed/refractory CLL/SLL/PLL of all risk categories with patients having deletion 17p13 independently evaluated.
This is a clinical trial, a type of research study, involving treatment with an investigational (experimental) drug called PCI-32765 (Ibrutinib), a "kinase inhibitor". "Kinases" are proteins that are inside of cells and help them to live and grow. The specific kinase inhibited or blocked by this study drug is believed to help blood cancer cells grow and live. By inhibiting or "blocking" the activity of this kinase, it is possible that the study drug may be able to kill the cancer cells or stop them from growing. This study will involve treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or B-cell prolymphocytic leukemia (B-PLL) that has not responded to or has relapsed after standard treatment. This trial is studying how effective PCI-32765 is at treating CLL, SLL, or B-PLL and all the effects, good and/or bad, treatment with this drug has on patients and their cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (ibrutinib) | Experimental | Patients will be treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibrutinib | Drug | Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL. | We will summarize our findings for this endpoint independently as well within each cohort (del17p vs other cytogenetic groups). We will evaluate the proportion of patients who are progression-free and alive at two years or have gone on to transplant (treatment successes) over the total number of evaluable patients; eligible patients who received at least one dose of therapy are considered evaluable. Assuming that the number of treatment successes as defined above is binomially distributed, we will also include 95% binomial confidence intervals for the estimates corresponding to each cohort. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response Rate Using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Working Group Guidelines | Responders were subjects who achieved a complete response (CR), partial response (PR) or PR with persistent lymphocytosis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kami Maddocks, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34608724 | Derived | Arrato NA, Valentine TR, Byrd JC, Jones JA, Maddocks KJ, Woyach JA, Andersen BL. Illness representations and psychological outcomes in chronic lymphocytic leukaemia. Br J Health Psychol. 2022 May;27(2):553-570. doi: 10.1111/bjhp.12562. Epub 2021 Oct 4. | |
| 28714866 | Derived | Long M, Beckwith K, Do P, Mundy BL, Gordon A, Lehman AM, Maddocks KJ, Cheney C, Jones JA, Flynn JM, Andritsos LA, Awan F, Fraietta JA, June CH, Maus MV, Woyach JA, Caligiuri MA, Johnson AJ, Muthusamy N, Byrd JC. Ibrutinib treatment improves T cell number and function in CLL patients. J Clin Invest. 2017 Aug 1;127(8):3052-3064. doi: 10.1172/JCI89756. Epub 2017 Jul 17. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Ibrutinib) | Patients were treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy. Patients received ibrutinib orally (PO) once daily(QD)on days 1-28. Courses repeat every 28 days in the absence of disease progression |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 20, 2020 | Jan 30, 2023 |
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| Correlative laboratory samples | Other | Blood samples will be collected and used for pharmacodynamic testing. Samples will be collected pre-dose on Cycle 1 Day 1 and 2 hours post-dose Cycle 1 Day 1, pre-dose on Day 2 and Day 8 of Cycle 1 and pre-dose on Day 1 of Cycles 2 and 3 and then every 3 cycles thereafter for 1 year (Cycle 15 Day 1). Samples will also be collected at the time of relapse and at any time when bone marrow biopsy is performed. |
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| quality of life assessment | Other | During screening, sociodemographic information (e.g., age, race, marital status) and reports of recent (last year) stressful events will be obtained. The assessment will consist of measures of emotional distress, depressive symptoms, and quality of life. Quality of life measures will be administered during screening and on Days 1 (±3), 8 (±3),, 15 (±3),, 22 (±3), of Cycle 1, Day 1 (±3), of Cycle 2 and on day 1 (±7) of Cycles 3, 6, and then every 3 months thru month 24. |
|
| up to 2 years |
| Number of Patients With 6 Month ORR of Single Agent Ibrutinib in Relapsed and Refractory CLL Patients | The 6 month overall response rates overall response rate (ORR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | Up to 6 months |
| Percentage of Patients With Overall Survival (OS) | Time from date of first treatment with ibrutinib until the date of death from any cause or the date of last contact for those alive. | 2 years |
| 2-year Kaplan-Meier Estimate of OS for Relapsed and Refractory CLL Patients Treated With Single Agent PCI-32765 | Time from date of first treatment with ibrutinib until the date of progression or death from any cause. Those alive and progression free are censored at the date of last clinical assessment. | 2 years |
| Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Adverse events grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with the attribution of either definite, possible or probable related. | Up to 2 years post treatment |
| Resistance Studies of Ibrutinib | Percentage of patients with BTK C481S mutation or PLCG2 mutation | Up to 4 years |
| Decrease in Immune Suppression of CLL Cells | up to 3 months |
| Effectiveness of Ibrutinib Bridging Patients to Allogeneic Stem Cell Transplant and Outcome of Patients Following This Intervention | The number of participants with successful Allogenic Stem Cell Transplant | Up to 2 years |
| Cancer-Specific Stress as Measured by the Impact of Event Scale-Revised (IES-R) | Cancer-Specific Stress was measured by the Impact of Event Scale-Revised Participants rated the intensity of these feelings using a five-point Likert scale ranging from 0=not at all to 4=extremely. Patients rated the frequency of their feelings or events for the previous week before treatment. The items were summed for a total score that ranged from 0 to 64 | Up to 2 years |
| Cognitive-Affective Depressive Symptoms as Measured by the Beck Depression Inventory-2nd Edition (BDI-II) | The Beck Depression Inventory-2nd edition is a 21-item measure of depressive symptoms. Scores were calculated representing the cognitive-affective and the somatic symptoms associated with depression (e.g. sadness, pessimism, loss of pleasure) during past month on scale from 0 to 3. Items were summed, with higher scores indicating more depressive symptoms. The scores on the scale from range from 0 to 42. | at 5 months |
| Negative Mood Quality of Life Measured by a 37-item Questionnaire | The Profile of Mood States-Short Form (POMS-SF) yields six subscales, Tension, Depression, Anger, Vigor, Fatigue, and Confusion. A total mood disturbance score is found by summing the six subscales. Total Mood Disturbance (TMD) scores range from -24 to 124 with higher scores indicating greater mood disturbance. | at 5 months |
| Mental Health Quality of Life Was Measured by the Mental Component Summary Score of the Medical Outcomes Study | SF-12 assesses aspects of quality of life including physical functioning, role functioning-physical, bodily pain, general health perceptions, vitality, social functioning, role functioning-emotional, and mental health. Subscale raw scores are transformed to put each subscale on a 0-100 range with higher scores indicative of greater functioning. Subscale scores are standardized based on US General Population norms and aggregated based on factor score coefficients into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Component scores are norm-based t-scores meaning scores above 50 indicate better functioning than average functioning while scores below 50 indicate worse functioning. | at 5 months |
| Fatigue Symptom Inventory (FSI) Interference Quality of Life as Measured by a 11-item Total Disruption Index Sub Scale of Fatigue Symptoms Inventory | The Fatigue Interference quality of life measures is a 11-item self reported questionnaire used to measure frequency, severity and daily pattern of fatigue Symptoms as well as impact of QOL in the past week. The Total Disruption Index (TDI) an 7 item subset of FSI was used. Items were rated on a 11-point Likert scale from 0=no interference to 10=extreme interference. Total scores could range from 0 to 70, with higher scores indicating greater fatigue interference. | at 5 months |
| Sleep Through Quality of Life as Measured by a Medical Outcomes Study-Sleep Scale | Sleep problems quality of life measures is a six-item sleep problems index I of the Medical Outcomes Study-Sleep Scale used to assess sleep problems. Participants reported how often they experience six specific difficulties with sleep on a 6-point Likert scale (1=All of the time to 6=None of the time). Scores transformed into a 0-100 scale with higher scores indicating greater sleep problems. | at 5 months |
| Physical Health Quality of Life as Measured by a 12 Item Short-Form Health Survey | Physical Health Quality of life measures were administered during screening and on Days 1 (±3), of Cycle 1, Day 1 (±3), of Cycle 2 and on day 1 (±7) of Cycles 3, 6, and then every 3 months thru Cycle 24 and at time of progression and /or end of treatment. SF-12 assesses aspects of quality of life including physical functioning, role functioning-physical, bodily pain, general health perceptions, vitality, social functioning, role functioning-emotional, and mental health. Subscale raw scores are transformed to put each subscale on a 0-100 range with higher scores indicative of greater functioning. Subscale scores are standardized based on US General Population norms and aggregated based on factor score coefficients into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Component scores are norm-based t-scores meaning scores above 50 indicate better functioning than average functioning while scores below 50 indicate worse functioning. | up to 5 months |
| 26182309 | Derived | Maddocks KJ, Ruppert AS, Lozanski G, Heerema NA, Zhao W, Abruzzo L, Lozanski A, Davis M, Gordon A, Smith LL, Mantel R, Jones JA, Flynn JM, Jaglowski SM, Andritsos LA, Awan F, Blum KA, Grever MR, Johnson AJ, Byrd JC, Woyach JA. Etiology of Ibrutinib Therapy Discontinuation and Outcomes in Patients With Chronic Lymphocytic Leukemia. JAMA Oncol. 2015 Apr;1(1):80-7. doi: 10.1001/jamaoncol.2014.218. |
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| Del17p patients |
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| Non-Del17p patients |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Ibrutinib) | Patients were treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy. Patients received ibrutinib orally (PO) once daily(QD)on days 1-28. Courses repeat every 28 days in the absence of disease progression |
| Units | Counts |
|---|---|
| Participants |
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| 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 | patients |
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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 | Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL. | We will summarize our findings for this endpoint independently as well within each cohort (del17p vs other cytogenetic groups). We will evaluate the proportion of patients who are progression-free and alive at two years or have gone on to transplant (treatment successes) over the total number of evaluable patients; eligible patients who received at least one dose of therapy are considered evaluable. Assuming that the number of treatment successes as defined above is binomially distributed, we will also include 95% binomial confidence intervals for the estimates corresponding to each cohort. | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | Posted | Number | 95% Confidence Interval | percentage of patients | up to 2 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Best Overall Response Rate Using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Working Group Guidelines | Responders were subjects who achieved a complete response (CR), partial response (PR) or PR with persistent lymphocytosis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | Posted | Number | 95% Confidence Interval | percentage of patients | up to 2 years |
| |||||||||||||||||||||||||||||
| Secondary | Number of Patients With 6 Month ORR of Single Agent Ibrutinib in Relapsed and Refractory CLL Patients | The 6 month overall response rates overall response rate (ORR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | Posted | Number | 95% Confidence Interval | patients | Up to 6 months |
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Overall Survival (OS) | Time from date of first treatment with ibrutinib until the date of death from any cause or the date of last contact for those alive. | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | Posted | Number | 95% Confidence Interval | percent of patients | 2 years |
|
| ||||||||||||||||||||||||||||
| Secondary | 2-year Kaplan-Meier Estimate of OS for Relapsed and Refractory CLL Patients Treated With Single Agent PCI-32765 | Time from date of first treatment with ibrutinib until the date of progression or death from any cause. Those alive and progression free are censored at the date of last clinical assessment. | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | Posted | Number | 95% Confidence Interval | percent of patients | 2 years |
| |||||||||||||||||||||||||||||
| Secondary | Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Adverse events grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with the attribution of either definite, possible or probable related. | Posted | Number | patients | Up to 2 years post treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Resistance Studies of Ibrutinib | Percentage of patients with BTK C481S mutation or PLCG2 mutation | Posted | Number | 95% Confidence Interval | percentage of patients | Up to 4 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Decrease in Immune Suppression of CLL Cells | Data was not collect and analyzed for this outcome measure | Posted | up to 3 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Effectiveness of Ibrutinib Bridging Patients to Allogeneic Stem Cell Transplant and Outcome of Patients Following This Intervention | The number of participants with successful Allogenic Stem Cell Transplant | Posted | Number | participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Cancer-Specific Stress as Measured by the Impact of Event Scale-Revised (IES-R) | Cancer-Specific Stress was measured by the Impact of Event Scale-Revised Participants rated the intensity of these feelings using a five-point Likert scale ranging from 0=not at all to 4=extremely. Patients rated the frequency of their feelings or events for the previous week before treatment. The items were summed for a total score that ranged from 0 to 64 | Data was reported for start of treatment only | Posted | Mean | Standard Deviation | units on a scale | Up to 2 years |
| |||||||||||||||||||||||||||||
| Secondary | Cognitive-Affective Depressive Symptoms as Measured by the Beck Depression Inventory-2nd Edition (BDI-II) | The Beck Depression Inventory-2nd edition is a 21-item measure of depressive symptoms. Scores were calculated representing the cognitive-affective and the somatic symptoms associated with depression (e.g. sadness, pessimism, loss of pleasure) during past month on scale from 0 to 3. Items were summed, with higher scores indicating more depressive symptoms. The scores on the scale from range from 0 to 42. | Data was reported for month 5 from start of treatment | Posted | Mean | Standard Deviation | units on a scale | at 5 months |
| |||||||||||||||||||||||||||||
| Secondary | Negative Mood Quality of Life Measured by a 37-item Questionnaire | The Profile of Mood States-Short Form (POMS-SF) yields six subscales, Tension, Depression, Anger, Vigor, Fatigue, and Confusion. A total mood disturbance score is found by summing the six subscales. Total Mood Disturbance (TMD) scores range from -24 to 124 with higher scores indicating greater mood disturbance. | Data was reported for month 5 from start of treatment | Posted | Mean | Standard Deviation | units on a scale | at 5 months |
| |||||||||||||||||||||||||||||
| Secondary | Mental Health Quality of Life Was Measured by the Mental Component Summary Score of the Medical Outcomes Study | SF-12 assesses aspects of quality of life including physical functioning, role functioning-physical, bodily pain, general health perceptions, vitality, social functioning, role functioning-emotional, and mental health. Subscale raw scores are transformed to put each subscale on a 0-100 range with higher scores indicative of greater functioning. Subscale scores are standardized based on US General Population norms and aggregated based on factor score coefficients into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Component scores are norm-based t-scores meaning scores above 50 indicate better functioning than average functioning while scores below 50 indicate worse functioning. | Posted | Mean | Standard Deviation | units on a scale | at 5 months |
| ||||||||||||||||||||||||||||||
| Secondary | Fatigue Symptom Inventory (FSI) Interference Quality of Life as Measured by a 11-item Total Disruption Index Sub Scale of Fatigue Symptoms Inventory | The Fatigue Interference quality of life measures is a 11-item self reported questionnaire used to measure frequency, severity and daily pattern of fatigue Symptoms as well as impact of QOL in the past week. The Total Disruption Index (TDI) an 7 item subset of FSI was used. Items were rated on a 11-point Likert scale from 0=no interference to 10=extreme interference. Total scores could range from 0 to 70, with higher scores indicating greater fatigue interference. | Data was reported for month 5 from the start of treatment | Posted | Mean | Standard Deviation | units on a scale | at 5 months |
| |||||||||||||||||||||||||||||
| Secondary | Sleep Through Quality of Life as Measured by a Medical Outcomes Study-Sleep Scale | Sleep problems quality of life measures is a six-item sleep problems index I of the Medical Outcomes Study-Sleep Scale used to assess sleep problems. Participants reported how often they experience six specific difficulties with sleep on a 6-point Likert scale (1=All of the time to 6=None of the time). Scores transformed into a 0-100 scale with higher scores indicating greater sleep problems. | Data was reported for month 5 from start of treatment | Posted | Mean | Standard Deviation | units on a scale | at 5 months |
| |||||||||||||||||||||||||||||
| Secondary | Physical Health Quality of Life as Measured by a 12 Item Short-Form Health Survey | Physical Health Quality of life measures were administered during screening and on Days 1 (±3), of Cycle 1, Day 1 (±3), of Cycle 2 and on day 1 (±7) of Cycles 3, 6, and then every 3 months thru Cycle 24 and at time of progression and /or end of treatment. SF-12 assesses aspects of quality of life including physical functioning, role functioning-physical, bodily pain, general health perceptions, vitality, social functioning, role functioning-emotional, and mental health. Subscale raw scores are transformed to put each subscale on a 0-100 range with higher scores indicative of greater functioning. Subscale scores are standardized based on US General Population norms and aggregated based on factor score coefficients into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Component scores are norm-based t-scores meaning scores above 50 indicate better functioning than average functioning while scores below 50 indicate worse functioning. | Data was reported for month 5 from start of treatment | Posted | Mean | Standard Deviation | units on a scale | up to 5 months |
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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 | Treatment (Ibrutinib) | Patients treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy. ibrutinib: Patients received ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progres | 152 | 152 | 152 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE version 4.0 | Systematic Assessment |
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| Hemolytic Uremic Syndrome | Blood and lymphatic system disorders | CTCAE version 4.0 | Systematic Assessment |
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| Lymph Node Pain | Blood and lymphatic system disorders | CTCAE version 4.0 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | CTCAE version 4.0 | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | CTCAE version 4.0 | Systematic Assessment |
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| Cardiac Disorders-other | Cardiac disorders | CTCAE version 4.0 | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | CTCAE version 4.0 | Systematic Assessment |
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| Ventricular Arrythmia | Cardiac disorders | CTCAE version 4.0 | Systematic Assessment |
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| Blurred Vision | Eye disorders | CTCAE version 4.0 | Systematic Assessment |
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| Colonic Perforation | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Esophageal Ulcer | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Gastric Hemorrhage | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Gastrointestinal Disorders-other | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Jejunal Hemorrhage | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Small Intestinal Obstruction | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Chills | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
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| Death NOS | General disorders and administration site conditions | CTCAE version 4.0 | Systematic Assessment |
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| Edema Limbs | General disorders and administration site conditions | CTCAE version 4.0 | Systematic Assessment |
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| Fatigue | General disorders and administration site conditions | CTCAE version 4.0 | Systematic Assessment |
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| Fever | General disorders and administration site conditions | CTCAE version 4.0 | Systematic Assessment |
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| General Disorders and Administration Site Conditions - Other | General disorders and administration site conditions | CTCAE version 4.0 | Systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders and administration site conditions | CTCAE version 4.0 | Systematic Assessment |
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| Sudden Death NOS | General disorders and administration site conditions | CTCAE version 4.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | CTCAE version 4.0 | Systematic Assessment |
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| Immune System Disorders - Other | Immune system disorders | CTCAE version 4.0 | Systematic Assessment |
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| Bone Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
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| Bronchial Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
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| Catheter Related Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Enterocolitis Infectious | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
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| Infections and Infestations-other | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
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| Lung Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
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| Otitis Media | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
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| Skin Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
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| Soft Tissue Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
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| Upper Respiratory Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE version 4.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE version 4.0 | Systematic Assessment |
| |
| Injury, Poisoning and Procedural Complications - Other | Injury, poisoning and procedural complications | CTCAE version 4.0 | Systematic Assessment |
| |
| Intestinal Stoma Obstruction | Injury, poisoning and procedural complications | CTCAE version 4.0 | Systematic Assessment |
| |
| Postoperative Hemorrhage | Injury, poisoning and procedural complications | CTCAE version 4.0 | Systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | CTCAE version 4.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Metabolism and Nutrition Disorders - Other | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Muscle Weakness Left Sided | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Musculoskeletal and Connective Tissue Disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Intracranial Hemorrhage | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Memory Impairement | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Nervous System Disorders - Other | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Transient Ischemic Attacks | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Psychiatric Disorders-Other | Psychiatric disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Renal and Urinary Disorders - Other | Renal and urinary disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Reproductive System and Breast Disorders - Other | Reproductive system and breast disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Respiratory, Thoracic, and Mediastinal Disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Surgical and Medical Procedures - Other | Surgical and medical procedures | CTCAE version 4.0 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Superior Vena Cava Syndrom | Vascular disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Thromboembolic Events | Vascular disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Vascular Disorders- Other | Vascular disorders | CTCAE version 4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Ear and Labyrinth disorders | Ear and labyrinth disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Eye Disorders | Eye disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Gastrointestional Disorder | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Oral Hemorrhage | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Stomach Pain | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Edema Limbs | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Flu Like Symptoms | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| General Disorders | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Non-Cardiac chest pain | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Bronchial Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Eye Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Infections and Infestations | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Nail Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Skin Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Upper Respiratory Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE version 4.0 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE version 4.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE version 4.0 | Systematic Assessment |
| |
| Injury, Poisoning and procedural complications | Injury, poisoning and procedural complications | CTCAE version 4.0 | Systematic Assessment | other |
|
| Lymphocyte count decreased | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| White Blood cell decreased | Investigations | CTCAE version 4.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Musculoskeletal and Connective tissue disorder-other | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Pain Extremity | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified-other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 4.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Nervous System Disorders-other | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE version 4.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kami Maddocks, MD | The Ohio State University Comprehensive Cancer Center | 614-293-3507 | Kami.Maddocks@osumc.edu |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D015463 | Leukemia, Prolymphocytic |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| 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 |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C551803 | ibrutinib |
Not provided
Not provided
Not provided
|
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