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This is a phase II open label trial designed to evaluate the efficacy of Tac/MTX/Toc in preventing graft versus host disease (GVHD). Outcomes of patients on this clinical trial will be compared to those of contemporary controls from the CIBMTR.
This is a Phase II open label trial designed to evaluate the efficacy of Tacrolimus (Tac), Methotrexate (MTX) and Tocilizumab (Toc) (combined Tac/MTX/Toc) in preventing graft versus host disease (GVHD) after allogeneic hematopoietic stem cell transplantation compared to a contemporary control cohort selected from the Center for International Bone Marrow Transplant Research (CIBMTR) that is treated with standard methotrexate and tacrolimus for GVHD prevention. The control group of patients will satisfy similar eligibility requirements as the patients enrolled in the clinical trial and they will be matched for relevant clinical variables (age, sex, conditioning regimen, disease, graft source, etc).
Patients enrolled in the clinical trial will receive tacrolimus per institutional guidelines at doses to maintain therapeutic levels and continued until at least Day 90 post transplant. Methotrexate will be dosed at 15 mg/m^2 Day +1 and 10mg/m^2 Days +3, +6 and +11. Tocilizumab will be administered intravenously at a dose of 8 mg/kg at Day -1.
Ancillary Study:
The ancillary study will evaluate whether tocilizumab is effective at positively impacting mood, fatigue, sleep, and pain in a group of individuals undergoing allogeneic hematopoietic stem cell transplantation as compared to individuals not receiving tocilizumab. We will also assess whether tocilizumab alters gene expression and Rap1 prenylation in a manner that may reduce further progression or relapse of cancer after transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus, Methotrexate and Tocilizumab (Tac/MTX/Toc) | Experimental | Patients enrolled in the clinical trial will receive tacrolimus per institutional guidelines at doses to maintain therapeutic levels and continued until at least Day 90 posttransplant. Methotrexate will be dosed at 15 mg/m2 Day +1 and 10mg/m2 Days +3, +6 and +11. Tocilizumab will be administered intravenously at a dose of 8 mg/kg at Day -1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | Patients enrolled in the clinical trial will receive tacrolimus per institutional guidelines at doses to maintain therapeutic levels and continued until at least Day 90 posttransplant. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Not Experiencing Grade II-IV Acute Graph Versus Host Disease (aGVHD) | This measure is the number of subjects who did not experience grade II-IV aGVHD at or before day 180 comparing recipients of tacrolimus (Tac), methotrexate (MTX), and tocilizumab (Toc) to a contemporary control population abstracted from a database maintained by the Center for International Blood and Marrow Transplant Research (CIBMTR). The staging of aGVHD was according to the criteria of Przepiorka, et al., 1995 which assigns a score to the clinical status of multiple organ systems aggregated to determine the clinical stage. A higher stage indicates more severe aGVHD symptoms and poorer clinical outcome. | Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Score of Depressive Symptoms Using General Depressive Subscale of the Inventory of Depression and Anxiety Symptoms (IDAS) Instrument | The measure of depressive symptoms will be determined from the Inventory of Depression and Anxiety Symptoms (IDAS) instrument. The IDAS contains 10 specific symptom scales: Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions (see Watson, 2007). The General Depression subscale of the IDAS and includes a subset of 20 five-item Likert-style questions (1= "Not at All" to 5-= "Extremely") with a scoring range of 20-100. Higher scores indicate more severe symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility for the Control Arm
Patients in the control arm will be identified from patients reported to the CIBMTR from U.S centers. Control patients will be required to satisfy similar eligibility requirements as patients being enrolled in the clinical trial. Patients will need to fulfill the same inclusion criteria for the clinical trial according to Section 2.4.1, plus the following:
Exclusion criteria for the controls:
1. Karnofsky Performance Score < 70%
Data for all eligible patients will be used to constitute the control database for this study
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| Name | Affiliation | Role |
|---|---|---|
| William Drobyski, MD | Medical College of Wisconsin | Principal Investigator |
| Marcelo Pasquini, MD | Medical College of Wisconsin | Principal Investigator |
| Jennifer Knight, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17845118 | Background | Watson D, O'Hara MW, Simms LJ, Kotov R, Chmielewski M, McDade-Montez EA, Gamez W, Stuart S. Development and validation of the Inventory of Depression and Anxiety Symptoms (IDAS). Psychol Assess. 2007 Sep;19(3):253-68. doi: 10.1037/1040-3590.19.3.253. | |
| 28606646 | Background | D'Souza A, Lee S, Zhu X, Pasquini M. Current Use and Trends in Hematopoietic Cell Transplantation in the United States. Biol Blood Marrow Transplant. 2017 Sep;23(9):1417-1421. doi: 10.1016/j.bbmt.2017.05.035. Epub 2017 Jun 9. |
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The populations used for historical controls were not recruited by theses investigators. To obtain matched controls, the number of records analyzed exceeds the number recruited locally for the interventional arm.
This investigation was conducted jointly by two research teams investigating the clinical effects, and the other investigating behavioral effects.. Each investigational team selected a population of matched historic controls appropriate to its outcome measures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tacrolimus, Methotrexate and Tocilizumab (Tac/MTX/Toc) | Patients enrolled in the clinical trial will receive tacrolimus per institutional guidelines at doses to maintain therapeutic levels and continued until at least Day 90 posttransplant. Methotrexate will be dosed at 15 mg/m^2 Day +1 and 10mg/m^2 Days +3, +6 and +11. Tocilizumab will be administered intravenously at a dose of 8 mg/kg at Day -1 Tacrolimus: Patients enrolled in the clinical trial will receive tacrolimus per institutional guidelines at doses to maintain therapeutic levels and continued until at least Day 90 posttransplant. Methotrexate: Methotrexate will be dosed at 15 mg/m^2 Day +1 and 10mg/m^2 Days +3, +6 and +11. Tocilizumab: Tocilizumab will be administered intravenously at a dose of 8 mg/kg at Day -1. |
| 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 |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2015 |
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|
| Methotrexate | Drug | Methotrexate will be dosed at 15 mg/m2 Day +1 and 10mg/m^2 Days +3, +6 and +11. |
|
|
| Tocilizumab | Drug | Tocilizumab will be administered intravenously at a dose of 8 mg/kg at Day -1. |
|
|
| Baseline, Day 28, Day 100 and Day 180 |
| Score of Anxiety Symptoms Using the Inventory of Depression and Anxiety Symptoms (IDAS) Instrument | Levels of anxiety symptoms will be measured using the Inventory of Depression and Anxiety Symptoms (IDAS) instrument. (see Watson, 2007). Anxiety will be assessed combining two domain categories of the IDAS (panic and traumatic intrusions). There are seven 5-item, Likert-style questions responding symptom severity "during the past 2 weeks, including today ..." ranging from 'Not at all' to 'Extremely.' Scores range from 0 to 28 with higher scores indicating worse symptoms. | Baseline, Day 28, Day 100 and Day 180 |
| Score of Fatigue Symptoms Using the Fatigue Symptom Inventory (FSI) Instrument | Levels of fatigue symptoms will be measured using the Fatigue Symptom Inventory instrument. The FSI comprises 13 eleven-item Likert-style questions ranging from 0 = "Not at all fatigued" to 10 -"Extreme fatigue". The FSI score is the average of the individual question scores. The range of scores is 0 to 10 with higher scores indicate greater fatigue (Hann, 1998). | Baseline, Day 28, Day 100 and Day 180 |
| Score of Sleep Symptoms Using the Pittsburgh Sleep Quality Index (PSQI) Instrument | Levels of sleep symptoms will be measured using the Pittsburgh Sleep Quality Index instrument. The PSQI contains 19 four-item Likert-style questions conducted over a 30-day period and 5 questions rated by the bed partner or roommate. Responses range from 0 = Not in the past month to 3 = Three or more times a week. The bed partner/roommate questions were not assessed. The 19 self-rated questions are grouped into seven component domains including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. See Buysse (1989), for the scoring schema of the component domains. The PSQI score is the sum of the seven component scores and ranges from 0 to 21. Higher scores indicate poorer sleep quality. | Baseline, Day 28, Day 100 and Day 180 |
| Score of Pain Symptoms Using the Brief Pain Inventory (BPI) Instrument (Interference) | Levels of interference in activities due to pain symptoms will be measured using the Brief Pain Inventory (BPI) instrument. The BPI Interference scale is a mean of 7 eleven-item Likert-style questions with a range of 0-10 (0 = Does not interfere to 10 = Completely interferes). Higher scores indicate greater interference in daily activities due to pain symptoms (see Cleeland 1994). | Baseline, Day 28, Day 100 and Day 180 |
| 7581076 | Background | Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995 Jun;15(6):825-8. |
| 25529383 | Background | Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18. |
| 9610214 | Background | Hann DM, Jacobsen PB, Azzarello LM, Martin SC, Curran SL, Fields KK, Greenberg H, Lyman G. Measurement of fatigue in cancer patients: development and validation of the Fatigue Symptom Inventory. Qual Life Res. 1998 May;7(4):301-10. doi: 10.1023/a:1024929829627. |
| 2748771 | Background | Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. |
| 8080219 | Background | Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. |
| FG001 | Historical Control Arm (Primary Outcome Measure) | This population was derived from case reports to the Center for International Blood and Marrow Transplant Research® (Milwaukee, WI) comprising patients receiving a first allogeneic transplant at a US site excluding the Medical College of Wisconsin. Additional population details can be found in D'Souza, 2017. (n=130) Race and ethnicity information was not collected for this control population. |
| FG002 | Historical Control Arm (Secondary Outcome Measures) | This population was derived from case reports from individuals participating in a longitudinal study evaluating biobehavioral effects on recovery following allogeneic hematopoietic cell transplantation at the University of Wisconsin-Madison. Patients received prophylaxis for graft versus host disease with methotrexate/tacrolimus. No patients received tocilizumab. (n=204). Patients receiving a second transplant; BCNU/carmustine, etoposide, cytarabine, and melphalan (BEAM) conditioning; total body irradiation; anti-thymocyte globulin, sirolimus; cord blood transplant; or cyclosporine/mycophenolate mofetil prophylaxis for graft versus host disease were excluded. Results presented are further limited to patients with acute myelogenous leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome to match the treatment population (n = 29). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tacrolimus, Methotrexate and Tocilizumab (Tac/MTX/Toc) | Patients enrolled in the clinical trial will receive tacrolimus per institutional guidelines at doses to maintain therapeutic levels and continued until at least Day 90 posttransplant. Methotrexate will be dosed at 15 mg/m2 Day +1 and 10mg/m^2 Days +3, +6 and +11. Tocilizumab will be administered intravenously at a dose of 8 mg/kg at Day -1 Tacrolimus: Patients enrolled in the clinical trial will receive tacrolimus per institutional guidelines at doses to maintain therapeutic levels and continued until at least Day 90 posttransplant. Methotrexate: Methotrexate will be dosed at 15 mg/m^2 Day +1 and 10mg/m^2 Days +3, +6 and +11. Tocilizumab: Tocilizumab will be administered intravenously at a dose of 8 mg/kg at Day -1. |
| BG001 | Historical Control Arm (Primary Outcome Measure) | This population was derived from case reports to the Center for International Blood and Marrow Transplant Research® (Milwaukee, WI) comprising patients receiving a first allogeneic transplant at a US site excluding the Medical College of Wisconsin. Additional population details can be found in D'Souza, 2017. (n=130) Race and ethnicity information was not collected for this control population. |
| BG002 | Historical Control Arm (Secondary Outcome Measures) | This population was derived from case reports from individuals participating in a longitudinal study evaluating biobehavioral effects on recovery following allogeneic hematopoietic cell transplantation at the University of Wisconsin-Madison. Patients received prophylaxis for graft versus host disease with methotrexate/tacrolimus. No patients received tocilizumab. (n=204). Patients receiving a second transplant; BCNU/carmustine, etoposide, cytarabine, and melphalan (BEAM) conditioning; total body irradiation; anti-thymocyte globulin; sirolimus; cord blood transplant; or cyclosporine/mycophenolate mofetil prophylaxis were excluded. Results presented are further limited to patients with acute myelogenous leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome to match the treatment population (n = 29). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||
| Sex: Female, Male | Gender demographics was not collected for the Historical Control Arm (Primary Outcome Measure) population. | Count of Participants | Participants |
| ||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Not Experiencing Grade II-IV Acute Graph Versus Host Disease (aGVHD) | This measure is the number of subjects who did not experience grade II-IV aGVHD at or before day 180 comparing recipients of tacrolimus (Tac), methotrexate (MTX), and tocilizumab (Toc) to a contemporary control population abstracted from a database maintained by the Center for International Blood and Marrow Transplant Research (CIBMTR). The staging of aGVHD was according to the criteria of Przepiorka, et al., 1995 which assigns a score to the clinical status of multiple organ systems aggregated to determine the clinical stage. A higher stage indicates more severe aGVHD symptoms and poorer clinical outcome. | The Historical Control Arm (Secondary Outcome Measures) cohort was included in this study for comparison of the behavioral results (Outcome Measures 2-6). The occurrence of aGVHD was not collected for this population. The Historical Control Arm (Secondary Outcome Measures) cohort has no clinical outcome for comparison and is not included in the analysis of this outcome measure. | Posted | Count of Participants | Participants | Day 180 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Score of Depressive Symptoms Using General Depressive Subscale of the Inventory of Depression and Anxiety Symptoms (IDAS) Instrument | The measure of depressive symptoms will be determined from the Inventory of Depression and Anxiety Symptoms (IDAS) instrument. The IDAS contains 10 specific symptom scales: Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions (see Watson, 2007). The General Depression subscale of the IDAS and includes a subset of 20 five-item Likert-style questions (1= "Not at All" to 5-= "Extremely") with a scoring range of 20-100. Higher scores indicate more severe symptoms. | The Historical Control Arm (Primary Outcome Measure) cohort was included in this study for comparison of clinical results (Outcome Measure 1). Behavioral outcomes were not collected for this historical population and this cohort is not included in the analysis of this outcome measure. Ten of the treated subjects in the interventional group did not consent to participate in the biobehavioral phase of the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 28, Day 100 and Day 180 |
| |||||||||||||||||||||||||||||||||
| Secondary | Score of Anxiety Symptoms Using the Inventory of Depression and Anxiety Symptoms (IDAS) Instrument | Levels of anxiety symptoms will be measured using the Inventory of Depression and Anxiety Symptoms (IDAS) instrument. (see Watson, 2007). Anxiety will be assessed combining two domain categories of the IDAS (panic and traumatic intrusions). There are seven 5-item, Likert-style questions responding symptom severity "during the past 2 weeks, including today ..." ranging from 'Not at all' to 'Extremely.' Scores range from 0 to 28 with higher scores indicating worse symptoms. | The Historical Control Arm (Primary Outcome Measure) cohort was included in this study for comparison of clinical results (Outcome Measure 1). Behavioral outcomes were not collected for this historical population and this cohort is not included in the analysis of this outcome measure. Ten of the treated subjects in the interventional group did not consent to participate in the biobehavioral phase of the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 28, Day 100 and Day 180 |
| |||||||||||||||||||||||||||||||||
| Secondary | Score of Fatigue Symptoms Using the Fatigue Symptom Inventory (FSI) Instrument | Levels of fatigue symptoms will be measured using the Fatigue Symptom Inventory instrument. The FSI comprises 13 eleven-item Likert-style questions ranging from 0 = "Not at all fatigued" to 10 -"Extreme fatigue". The FSI score is the average of the individual question scores. The range of scores is 0 to 10 with higher scores indicate greater fatigue (Hann, 1998). | The Historical Control Arm (Primary Outcome Measure) cohort was included in this study for comparison of clinical results (Outcome Measure 1). Behavioral outcomes were not collected for this historical population and this cohort is not included in the analysis of this outcome measure. Ten of the treated subjects in the interventional group did not consent to participate in the biobehavioral phase of the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 28, Day 100 and Day 180 |
| |||||||||||||||||||||||||||||||||
| Secondary | Score of Sleep Symptoms Using the Pittsburgh Sleep Quality Index (PSQI) Instrument | Levels of sleep symptoms will be measured using the Pittsburgh Sleep Quality Index instrument. The PSQI contains 19 four-item Likert-style questions conducted over a 30-day period and 5 questions rated by the bed partner or roommate. Responses range from 0 = Not in the past month to 3 = Three or more times a week. The bed partner/roommate questions were not assessed. The 19 self-rated questions are grouped into seven component domains including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. See Buysse (1989), for the scoring schema of the component domains. The PSQI score is the sum of the seven component scores and ranges from 0 to 21. Higher scores indicate poorer sleep quality. | The Historical Control Arm (Primary Outcome Measure) cohort was included in this study for comparison of clinical results (Outcome Measure 1). Behavioral outcomes were not collected for this historical population and this cohort is not included in the analysis of this outcome measure. Ten of the treated subjects in the interventional group did not consent to participate in the biobehavioral phase of the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 28, Day 100 and Day 180 |
| |||||||||||||||||||||||||||||||||
| Secondary | Score of Pain Symptoms Using the Brief Pain Inventory (BPI) Instrument (Interference) | Levels of interference in activities due to pain symptoms will be measured using the Brief Pain Inventory (BPI) instrument. The BPI Interference scale is a mean of 7 eleven-item Likert-style questions with a range of 0-10 (0 = Does not interfere to 10 = Completely interferes). Higher scores indicate greater interference in daily activities due to pain symptoms (see Cleeland 1994). | The Historical Control Arm (Primary Outcome Measure) cohort was included in this study for comparison of clinical results (Outcome Measure 1). Behavioral outcomes were not collected for this historical population and this cohort is not included in the analysis of this outcome measure. Ten of the treated subjects in the interventional group did not consent to participate in the biobehavioral phase of the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 28, Day 100 and Day 180 |
|
12 months
Adverse events information was not collected for the historical control groups.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tacrolimus, Methotrexate and Tocilizumab (Tac/MTX/Toc) | Patients enrolled in the clinical trial will receive tacrolimus per institutional guidelines at doses to maintain therapeutic levels and continued until at least Day 90 posttransplant. Methotrexate will be dosed at 15 mg/m2 Day +1 and 10mg/m2 Days +3, +6 and +11. Tocilizumab will be administered intravenously at a dose of 8 mg/kg at Day -1 Tacrolimus: Patients enrolled in the clinical trial will receive tacrolimus per institutional guidelines at doses to maintain therapeutic levels and continued until at least Day 90 posttransplant. Methotrexate: Methotrexate will be dosed at 15 mg/m2 Day +1 and 10mg/m^2 Days +3, +6 and +11. Tocilizumab: Tocilizumab will be administered intravenously at a dose of 8 mg/kg at Day -1. The adverse events reported (serious and non-serious) include only those events experienced by subjects enrolled at the Medical College of Wisconsin site. Adverse events and serious adverse events were not abstracted from the databases for the two historical control populations. | 13 | 35 | 4 | 35 | 35 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain - Cardiac | Cardiac disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE 4.03 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE 4.03 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Drobyski, MD | Froedtert and the Medical college of Wisconsin | 414-456-4941 | wdrobysk@mcw.edu |
| Dec 13, 2022 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 28, 2015 | Dec 13, 2022 | ICF_003.pdf |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D008727 | Methotrexate |
| C502936 | tocilizumab |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
|
|
|
| OG001 | Historical Control Arm (Primary Outcome Measure) | This population was derived from case reports to the Center for International Blood and Marrow Transplant Research® (Milwaukee, WI) comprising patients receiving a first allogeneic transplant at a US site excluding the Medical College of Wisconsin. Additional population details can be found in D'Souza, 2017.05.035. (n=130) Race and ethnicity information was not collected for this control population. |
| OG002 | Historical Control Arm (Secondary Outcome Measures) | This population was derived from case reports from individuals participating in a longitudinal study evaluating biobehavioral effects on recovery following allogeneic hematopoietic cell transplantation at the University of Wisconsin-Madison. Patients received prophylaxis for graft versus host disease with methotrexate/tacrolimus. No patients received tocilizumab. (n=204). Patients receiving a second transplant, BEAM conditioning (BCNU/carmustine, etoposide, cytarabine, and melphalan), total body irradiation, anti-thymocyte globulin, sirolimus, cord blood transplant, or cyclosporine/mycophenolate mofetil GVHD prophylaxis were excluded. Results presented are further limited to patients with acute myelogenous leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome to match the treatment population (n = 29). |
|
|
|
| OG001 | Historical Control Arm (Primary Outcome Measure) | This population was derived from case reports to the Center for International Blood and Marrow Transplant Research® (Milwaukee, WI) comprising patients receiving a first allogeneic transplant at a US site excluding the Medical College of Wisconsin. Additional population details can be found in D'Souza, 2017.05.035. (n=130) Race and ethnicity information was not collected for this control population. |
| OG002 | Historical Control Arm (Secondary Outcome Measures) | This population was derived from case reports from individuals participating in a longitudinal study evaluating biobehavioral effects on recovery following allogeneic hematopoietic cell transplantation at the University of Wisconsin-Madison. Patients received prophylaxis for graft versus host disease with methotrexate/tacrolimus. No patients received tocilizumab. (n=204). Patients receiving a second transplant, BEAM conditioning (BCNU/carmustine, etoposide, cytarabine, and melphalan), total body irradiation, anti-thymocyte globulin, sirolimus, cord blood transplant, or cyclosporine/mycophenolate mofetil GVHD prophylaxis were excluded. Results presented are further limited to patients with acute myelogenous leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome to match the treatment population (n = 29). |
|
|
|
| OG001 | Historical Control Arm (Primary Outcome Measure) | This population was derived from case reports to the Center for International Blood and Marrow Transplant Research® (Milwaukee, WI) comprising patients receiving a first allogeneic transplant at a US site excluding the Medical College of Wisconsin. Additional population details can be found in D'Souza, 2017.05.035. (n=130) Race and ethnicity information was not collected for this control population. |
| OG002 | Historical Control Arm (Secondary Outcome Measures) | This population was derived from case reports from individuals participating in a longitudinal study evaluating biobehavioral effects on recovery following allogeneic hematopoietic cell transplantation at the University of Wisconsin-Madison. Patients received prophylaxis for graft versus host disease with methotrexate/tacrolimus. No patients received tocilizumab. (n=204). Patients receiving a second transplant, BEAM conditioning (BCNU/carmustine, etoposide, cytarabine, and melphalan), total body irradiation, anti-thymocyte globulin, sirolimus, cord blood transplant, or cyclosporine/mycophenolate mofetil GVHD prophylaxis were excluded. Results presented are further limited to patients with acute myelogenous leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome to match the treatment population (n = 29). |
|
|
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| OG001 | Historical Control Arm (Primary Outcome Measure) | This population was derived from case reports to the Center for International Blood and Marrow Transplant Research® (Milwaukee, WI) comprising patients receiving a first allogeneic transplant at a US site excluding the Medical College of Wisconsin. Additional population details can be found in D'Souza, 2017.05.035. (n=130) Race and ethnicity information was not collected for this control population. |
| OG002 | Historical Control Arm (Secondary Outcome Measures) | This population was derived from case reports from individuals participating in a longitudinal study evaluating biobehavioral effects on recovery following allogeneic hematopoietic cell transplantation at the University of Wisconsin-Madison. Patients received prophylaxis for graft versus host disease with methotrexate/tacrolimus. No patients received tocilizumab. (n=204). Patients receiving a second transplant, BEAM conditioning (BCNU/carmustine, etoposide, cytarabine, and melphalan), total body irradiation, anti-thymocyte globulin, sirolimus, cord blood transplant, or cyclosporine/mycophenolate mofetil GVHD prophylaxis were excluded. Results presented are further limited to patients with acute myelogenous leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome to match the treatment population (n = 29). |
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| OG001 | Historical Control Arm (Primary Outcome Measure) | This population was derived from case reports to the Center for International Blood and Marrow Transplant Research® (Milwaukee, WI) comprising patients receiving a first allogeneic transplant at a US site excluding the Medical College of Wisconsin. Additional population details can be found in D'Souza, 2017.05.035. (n=130) Race and ethnicity information was not collected for this control population. |
| OG002 | Historical Control Arm (Secondary Outcome Measures) | This population was derived from case reports from individuals participating in a longitudinal study evaluating biobehavioral effects on recovery following allogeneic hematopoietic cell transplantation at the University of Wisconsin-Madison. Patients received prophylaxis for graft versus host disease with methotrexate/tacrolimus. No patients received tocilizumab. (n=204). Patients receiving a second transplant, BEAM conditioning (BCNU/carmustine, etoposide, cytarabine, and melphalan), total body irradiation, anti-thymocyte globulin, sirolimus, cord blood transplant, or cyclosporine/mycophenolate mofetil GVHD prophylaxis were excluded. Results presented are further limited to patients with acute myelogenous leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome to match the treatment population (n = 29). |
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