Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MPD-RC 114 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Myeloproliferative Disorders-Research Consortium | NETWORK |
| National Cancer Institute (NCI) | NIH |
| Incyte Corporation | INDUSTRY |
| Novartis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to find out if giving the study drug Ruxolitinib (INC424) prior to a combination of other chemotherapeutic drugs (Fludarabine and Busulfan) before infusing another person's hematopoietic stem cells (bone marrow transplantation) will be successful in people who have advanced primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF), collectively known as myelofibrosis (MF). MF is a disorder in which bone marrow tissue develops in abnormal sites because the bone marrow itself undergoes fibrosis or scarring. This study plans to evaluate whether adding the drug Ruxolitinib will further aid in reducing pre-transplant spleen size, improve physical performance levels and reduce adverse events (side effects) related to the transplant. Ruxolitinib is a drug that is approved by the FDA for the treatment of patients with advanced forms of myelofibrosis. Using Ruxolitinib prior to stem cell transplantation is experimental.
A two- stage Simon Phase II study will be conducted in each of two groups of patients: related and unrelated donor transplants. In each donor transplant group, the first stage of this design will include 11 patients evaluated for death or graft failure by 100 days post-transplant. In each stratum, we will enroll additional patients (up to 20%) of stratum total to take into account exclusions due to donor failure (such as donor deemed unsuitable for stem cell donation due to medical or other reasons) only. Those patients who have toxicities related to Ruxolitinib and not been able to reach HCT due to these toxicities will be included in the estimation of overall failure rates. Only those patients who are excluded based on donor related issues without any regimen related complications will be excluded from the estimation of failure rates. However, all data on these patients will be reported.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) | Experimental | Ruxolitinib (INC424) tablets will be started 62 days (day -67) prior to start of conditioning chemotherapy. The starting dose of Ruxolitinib will be determined according to baseline platelet count and will be modified according to platelet count at follow-up. The drug will be given in the maximum tolerated dose as defined in the protocol for 56 days, followed by 4 days of taper, and will be stopped completely at the planned start of conditioning therapy (starting on day -5) i.e. 5 days prior to stem cell infusion. The drug will be supplied as 5 mg tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) | Drug | Ruxolitinib (INC424) tablets will be started 60 days (day -65) prior to start of conditioning chemotherapy. The starting dose of Ruxolitinib will be determined according to baseline platelet count and will be modified according to platelet count at follow-up. The drug will be given in the maximum tolerated dose as defined in the protocol for 56 days, followed by 4 days of taper, and will be stopped completely at the planned start of conditioning therapy (starting on day -5) i.e. 5 days prior to stem cell infusion. The drug will be supplied as 5 mg tablets. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With 100-day Survival Without Graft Failure | The feasibility of combining Ruxolitinib (INC424) with a Reduced intensity conditioning (RIC) regimen likely to produce success post transplantation, success being defined as patient being alive, and without graft failure at day 100-post allogeneic stem cell transplantation (in patients who receive (a) related donor transplant and in those who receive (b) an unrelated donor transplant. | Day 100-post allogeneic stem cell transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Neutrophil Recovery | Neutrophil recovery will be defined as first of the three consecutive days with neutrophil count ≥0.5 x 109/l. | up to 4 years |
| Platelet Recovery | Platelet recovery will be defined as first of the 7 days with platelet count ≥20 x 109/l, without platelet transfusion support and both maintained for 30 days without transfusion support or myeloid cytokine support. |
Not provided
Inclusion Criteria:
Documented diagnosis of primary myelofibrosis according to WHO criteria or post PV myelofibrosis or post ET myelofibrosis as per IWG-MRT criteria
Age 18-70 years
Intermediate-2/ high-risk disease as per Dynamic IPSS (DIPSS) criteria OR Intermediate-1 risk disease with one of the following additional unfavorable features known to impact the survival adversely
Blasts in the PB and BM ≤10% prior to study enrollment
Availability of a suitable matched related (6/6 or 5/6) or unrelated donor (10/10 or 9/10 antigen or allele matched).
Able to give informed written consent
ECOG Performance status of 0-2.
Life expectancy >3 months
Off all MF-directed therapy including investigational agents for at least 2 weeks prior to study enrollment and recovered from all toxicities*
Adequate organ function
Adequate renal function - creatinine <1.5 x IULN
Adequate hepatic function - AST/ALT <2.5 x IULN, Total Bilirubin <1.5 x IULN
Adequate hematopoietic function - Platelet ≥50 x 109/l and ANC ≥1.0 x 109/l
LVEF >40% (MUGA or echocardiogram) Normal per Institutional standard
Adequate pulmonary function with DLCO >50%
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Mascarenhas, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Vikas Gupta, MD, FRCP, FRCPath | University of Toronto | Study Chair |
| Adam Mead, MD | University of Oxford, John Radcliffe Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Hospital | Atlanta | Georgia | 30322 | United States | ||
| Northwestern University, Robert h. Lurie Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30205231 | Derived | Gupta V, Kosiorek HE, Mead A, Klisovic RB, Galvin JP, Berenzon D, Yacoub A, Viswabandya A, Mesa RA, Goldberg J, Price L, Salama ME, Weinberg RS, Rampal R, Farnoud N, Dueck AC, Mascarenhas JO, Hoffman R. Ruxolitinib Therapy Followed by Reduced-Intensity Conditioning for Hematopoietic Cell Transplantation for Myelofibrosis: Myeloproliferative Disorders Research Consortium 114 Study. Biol Blood Marrow Transplant. 2019 Feb;25(2):256-264. doi: 10.1016/j.bbmt.2018.09.001. Epub 2018 Sep 8. |
Not provided
Not provided
Not provided
Recruitment began in February 2013, with first enrollment in November 2013.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ruxolitinib Pre- Hematopoietic Cell Transplantation (HCT) | Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) in Patients With Myelofibrosis. Ruxolitinib (INC424) tablets started 60 days (day -65) prior to start of conditioning chemotherapy. The starting dose of Ruxolitinib was determined according to baseline platelet count and modified according to platelet count at follow-up. The drug was given in the maximum tolerated dose as defined in the protocol for 56 days, followed by 4 days of taper, and stopped completely at the planned start of conditioning therapy (starting on day -5) i.e. 5 days prior to stem cell infusion. The drug was supplied as 5 mg tablets. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 8, 2016 |
| INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| up to 4 years |
| Percent of Participants With Non-relapse Mortality (NRM) | NRM will be defined as death in first 30 days due to any cause, and subsequently death due to any cause without the recurrence or progression of myelofibrosis. Cumulative incidence of NRM will be calculated taking relapse/progression as competing event. | 100 days |
| Percent of Participants With Non-relapse Mortality (NRM) | NRM will be defined as death in first 30 days due to any cause, and subsequently death due to any cause without the recurrence or progression of myelofibrosis. Cumulative incidence of NRM will be calculated taking relapse/progression as competing event. | 1-year post transplant |
| Percent of Participants With Graft Versus Host Disease (GvHD) | Acute and chronic GvHD. GvHD is a potentially serious complication of allogeneic stem cell transplantation. Stage Skin Liver (bilirubin) Gut (stool output/day) 0 No GVHD rash < 2 mg/dl < 500 ml/day or persistent nausea.
| 1-year post transplant |
| Chimerism Studies | Will check percentage of donor versus recipient blood cells to determine efficacy of donor engraftment | 30 days post transplant |
| Chimerism Studies | Will check percentage of donor versus recipient blood cells to determine efficacy of donor engraftment | 60 days post transplant |
| Chimerism Studies | Will check percentage of donor versus recipient blood cells to determine efficacy of donor engraftment | 100 days post transplant |
| Number of Participants With Remission Status According to IWG-MRT Criteria | Remission status according to International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria Remission defined as: Bone marrow:* Age-adjusted normocellularity; <5% blasts; ≤grade 1 MF and Peripheral blood: Hemoglobin ≥100 g/L and \ | Day 100 post transplant |
| Number of Participants With Remission Status at 6 Months Post Transplant | Remission defined as: Bone marrow:* Age-adjusted normocellularity; <5% blasts; ≤grade 1 MF†and Peripheral blood: Hemoglobin ≥100 g/L and \ | 6 months post transplant |
| Number of Participants With Remission Status at 12 Months Post Transplant | Remission defined as: Bone marrow:* Age-adjusted normocellularity; <5% blasts; ≤grade 1 MF†and Peripheral blood: Hemoglobin ≥100 g/L and \ | 12 months post transplant |
| Number of Participants With Relapse/Progression (Defined as Per IWG-MRT Criteria) | Relapse/progression defined as: Peripheral blood: Hemoglobin ≥100 g/L and \ | 1-year post transplant |
| Number of Participants With Progression-free Survival | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 1-year post transplant |
| Number of Overall Survival | 1-year post transplant |
| Mean Change in the Brief Fatigue Inventory Score | Mean change in the Brief Fatigue Inventory score (BFI) from baseline to 48 months to assess impact of allogeneic stem cell transplant on myelofibrosis associated symptoms and overall quality of life. The BFI is a 9 item scored from 0 (no fatigue) -10 (as bad as you can imagine), items are averaged with total score from 0-10, with higher score indicating more fatigue. | baseline and 48 months |
| Expression Profiling and Measurements of Cytokines Prior to Start of Ruxolitinib, Prior to Start of Chemotherapy for Conditioning | 30 days post transplant |
| Expression Profiling and Measurements of Cytokines Prior to Start of Ruxolitinib, Prior to Start of Chemotherapy for Conditioning | 100 days post transplant |
| Association of Cytokines Levels With Acute and Chronic GvHD | 30 days post transplant |
| Association of Cytokines Levels With Acute and Chronic GvHD | 100 days post transplant |
| Chicago |
| Illinois |
| 60611 |
| United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Princess Margaret Cancer Centre, University of Toronto | Toronto | M5G 2M9 | Canada |
| University of Oxford | Oxford | OX3 9DS | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ruxolitinib Pre- Hematopoietic Cell Transplantation (HCT) | Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) in Patients With Myelofibrosis Ruxolitinib (INC424) tablets started 60 days (day -65) prior to start of conditioning chemotherapy. The starting dose of Ruxolitinib was determined according to baseline platelet count and modified according to platelet count at follow-up. The drug was given in the maximum tolerated dose as defined in the protocol for 56 days, followed by 4 days of taper, and stopped completely at the planned start of conditioning therapy (starting on day -5) i.e. 5 days prior to stem cell infusion. The drug was supplied as 5 mg tablets. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Diagnosis | Primary Myelofibrosis Post Polycythemia Vera (Post-PV) Myelofibrosis Post Essential Thrombocythemia (Post-ET) Myelofibrosis | Count of Participants | Participants |
| ||||||||||||||||||||||
| Donor type | Count of Participants | Participants |
| |||||||||||||||||||||||
| ECOG status | The Eastern Cooperative Oncology Group (ECOG) measures level of functioning in terms of daily living abilities: The ECOG measures level of functioning in terms of daily living abilities: 0-Fully active, able to carry on all pre-disease performance without restriction 1-Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg.light house work | Count of Participants | 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 | Percent of Participants With 100-day Survival Without Graft Failure | The feasibility of combining Ruxolitinib (INC424) with a Reduced intensity conditioning (RIC) regimen likely to produce success post transplantation, success being defined as patient being alive, and without graft failure at day 100-post allogeneic stem cell transplantation (in patients who receive (a) related donor transplant and in those who receive (b) an unrelated donor transplant. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 100-post allogeneic stem cell transplantation |
|
|
| ||||||||||||||||||||||||||
| Secondary | Time to Neutrophil Recovery | Neutrophil recovery will be defined as first of the three consecutive days with neutrophil count ≥0.5 x 109/l. | Posted | Median | 95% Confidence Interval | days | up to 4 years |
|
| |||||||||||||||||||||||||||
| Secondary | Platelet Recovery | Platelet recovery will be defined as first of the 7 days with platelet count ≥20 x 109/l, without platelet transfusion support and both maintained for 30 days without transfusion support or myeloid cytokine support. | Posted | Median | 95% Confidence Interval | days | up to 4 years |
|
| |||||||||||||||||||||||||||
| Secondary | Percent of Participants With Non-relapse Mortality (NRM) | NRM will be defined as death in first 30 days due to any cause, and subsequently death due to any cause without the recurrence or progression of myelofibrosis. Cumulative incidence of NRM will be calculated taking relapse/progression as competing event. | Posted | Number | 95% Confidence Interval | percentage of participants | 100 days |
|
| |||||||||||||||||||||||||||
| Secondary | Percent of Participants With Non-relapse Mortality (NRM) | NRM will be defined as death in first 30 days due to any cause, and subsequently death due to any cause without the recurrence or progression of myelofibrosis. Cumulative incidence of NRM will be calculated taking relapse/progression as competing event. | Posted | Number | 95% Confidence Interval | percentage of participants | 1-year post transplant |
|
| |||||||||||||||||||||||||||
| Secondary | Percent of Participants With Graft Versus Host Disease (GvHD) | Acute and chronic GvHD. GvHD is a potentially serious complication of allogeneic stem cell transplantation. Stage Skin Liver (bilirubin) Gut (stool output/day) 0 No GVHD rash < 2 mg/dl < 500 ml/day or persistent nausea.
| Posted | Number | 95% Confidence Interval | percentage of participants | 1-year post transplant |
|
| |||||||||||||||||||||||||||
| Secondary | Chimerism Studies | Will check percentage of donor versus recipient blood cells to determine efficacy of donor engraftment | This data was not collected because the study ended early. | Posted | 30 days post transplant |
|
| |||||||||||||||||||||||||||||
| Secondary | Chimerism Studies | Will check percentage of donor versus recipient blood cells to determine efficacy of donor engraftment | This data was not collected because the study ended early. | Posted | 60 days post transplant |
|
| |||||||||||||||||||||||||||||
| Secondary | Chimerism Studies | Will check percentage of donor versus recipient blood cells to determine efficacy of donor engraftment | This data was not collected because the study ended early. | Posted | 100 days post transplant |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Remission Status According to IWG-MRT Criteria | Remission status according to International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria Remission defined as: Bone marrow:* Age-adjusted normocellularity; <5% blasts; ≤grade 1 MF and Peripheral blood: Hemoglobin ≥100 g/L and \ | Posted | Count of Participants | Participants | Day 100 post transplant |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Remission Status at 6 Months Post Transplant | Remission defined as: Bone marrow:* Age-adjusted normocellularity; <5% blasts; ≤grade 1 MF†and Peripheral blood: Hemoglobin ≥100 g/L and \ | Posted | Count of Participants | Participants | 6 months post transplant |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Remission Status at 12 Months Post Transplant | Remission defined as: Bone marrow:* Age-adjusted normocellularity; <5% blasts; ≤grade 1 MF†and Peripheral blood: Hemoglobin ≥100 g/L and \ | Posted | Count of Participants | Participants | 12 months post transplant |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Relapse/Progression (Defined as Per IWG-MRT Criteria) | Relapse/progression defined as: Peripheral blood: Hemoglobin ≥100 g/L and \ | Posted | Count of Participants | Participants | 1-year post transplant |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Progression-free Survival | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Posted | Count of Participants | Participants | 1-year post transplant |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Overall Survival | Posted | Count of Participants | Participants | 1-year post transplant |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Change in the Brief Fatigue Inventory Score | Mean change in the Brief Fatigue Inventory score (BFI) from baseline to 48 months to assess impact of allogeneic stem cell transplant on myelofibrosis associated symptoms and overall quality of life. The BFI is a 9 item scored from 0 (no fatigue) -10 (as bad as you can imagine), items are averaged with total score from 0-10, with higher score indicating more fatigue. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline and 48 months |
|
| |||||||||||||||||||||||||||
| Secondary | Expression Profiling and Measurements of Cytokines Prior to Start of Ruxolitinib, Prior to Start of Chemotherapy for Conditioning | This data was not collected because the study ended early. | Posted | 30 days post transplant |
|
| ||||||||||||||||||||||||||||||
| Secondary | Expression Profiling and Measurements of Cytokines Prior to Start of Ruxolitinib, Prior to Start of Chemotherapy for Conditioning | This data was not collected because the study ended early. | Posted | 100 days post transplant |
|
| ||||||||||||||||||||||||||||||
| Secondary | Association of Cytokines Levels With Acute and Chronic GvHD | This data was not collected because the study ended early. | Posted | 30 days post transplant |
|
| ||||||||||||||||||||||||||||||
| Secondary | Association of Cytokines Levels With Acute and Chronic GvHD | This data was not collected because the study ended early. | Posted | 100 days post transplant |
|
|
up to 4 years
Not provided
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 | Ruxolitinib Pre- Hematopoietic Cell Transplantation (HCT) | Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) in Patients With Myelofibrosis Ruxolitinib (INC424) tablets started 60 days (day -65) prior to start of conditioning chemotherapy. The starting dose of Ruxolitinib was determined according to baseline platelet count and modified according to platelet count at follow-up. The drug was given in the maximum tolerated dose as defined in the protocol for 56 days, followed by 4 days of taper, and stopped completely at the planned start of conditioning therapy (starting on day -5) i.e. 5 days prior to stem cell infusion. The drug was supplied as 5 mg tablets. | 4 | 21 | 13 | 21 | 20 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug-induced hyperglycemia | Endocrine disorders | Systematic Assessment |
| ||
| Diverticulitis NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea post chemotherapy | Gastrointestinal disorders | Systematic Assessment |
| ||
| Death sudden | General disorders | Systematic Assessment |
| ||
| Neutropenic fever | General disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Graft failure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Elevated liver enzyme levels | Investigations | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Intracranial hemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Spinal epidural hematoma | Nervous system disorders | Systematic Assessment |
| ||
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Disease Progression | General disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Activated partial thromboplastin time | Investigations | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute myeloid leukemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Agitation | Nervous system disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Allergic rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Alloimmunization | Immune system disorders | Systematic Assessment |
| ||
| Anal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Ankle edema | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain (without radiation) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bloating | Gastrointestinal disorders | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Blurred vision | Eye disorders | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bronchospasm | Immune system disorders | Systematic Assessment |
| ||
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Burning from urination | Renal and urinary disorders | Systematic Assessment |
| ||
| Burning sensation | Nervous system disorders | Systematic Assessment |
| ||
| C.difficile diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| CMV infection | Infections and infestations | Systematic Assessment |
| ||
| Cardiac neoplasm unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
| ||
| Cataract | Eye disorders | Systematic Assessment |
| ||
| Catheter site erythema | General disorders | Systematic Assessment |
| ||
| Chest congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chest pain - cardiac | Cardiac disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
| ||
| Clostridium difficile test positive | Infections and infestations | Systematic Assessment |
| ||
| Confusion | Nervous system disorders | Systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Systematic Assessment |
| ||
| Conjunctivitis | Eye disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Contusion | Vascular disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Creatinine increased | Investigations | Systematic Assessment |
| ||
| Cytokine release syndrome | Immune system disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Diaphoresis | General disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Double vision | Eye disorders | Systematic Assessment |
| ||
| Drug-induced liver disease | Eye disorders | Systematic Assessment |
| ||
| Dry eye | Eye disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dysgeusia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Edema extremities | General disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Facial swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fecal incontinence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Fibrinogen decreased | Investigations | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Folliculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Foot injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| GGT Increased | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Gout | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Gynecomastia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| HSV infection | Infections and infestations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hearing impaired | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Hematoma | Vascular disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Hemoglobin decreased | Investigations | Systematic Assessment |
| ||
| Hemolysis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hoarseness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypermagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypertension | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypertriglyceridemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperuricemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| INR increased | Investigations | Systematic Assessment |
| ||
| Increased TSH | Investigations | Systematic Assessment |
| ||
| Infusion site cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Insomnia | Nervous system disorders | Systematic Assessment |
| ||
| Insufficiency adrenal | Endocrine disorders | Systematic Assessment |
| ||
| Iron deficiency anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Irritation lips | Gastrointestinal disorders | Systematic Assessment |
| ||
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Laboratory test abnormal | Investigations | Systematic Assessment |
| ||
| Left lower quadrant pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Lethargy | General disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lightheadedness | Vascular disorders | Systematic Assessment |
| ||
| Lung infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Lymphocyte count increased | Investigations | Systematic Assessment |
| ||
| Maculopapular rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Middle ear inflammation | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Night blindness | Eye disorders | Systematic Assessment |
| ||
| Night sweats | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Open wound of foot except toe(s) alone | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Oral hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Painful urination | Renal and urinary disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Paraplegia | Nervous system disorders | Systematic Assessment |
| ||
| Perianal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Periocular rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Peripheral motor neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Petechiae | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Plasma creatinine increased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Polymyalgia rheumatica | Immune system disorders | Systematic Assessment |
| ||
| Post procedural discomfort | General disorders | Systematic Assessment |
| ||
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pressure sore | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Presyncope | Cardiac disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pseudogout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Rash acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Renal calculi | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory syncytial virus infection | Infections and infestations | Systematic Assessment |
| ||
| Rigors | General disorders | Systematic Assessment |
| ||
| Scleral hemorrhage | Eye disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Skin desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| Skin lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sleep apnea | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Sore throat | Gastrointestinal disorders | Systematic Assessment |
| ||
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Syncope | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Tooth pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection bacterial | Infections and infestations | Systematic Assessment |
| ||
| Urinary incontinence | Nervous system disorders | Systematic Assessment |
| ||
| Urinary hesitancy | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urticaria | Immune system disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Weakness | General disorders | Systematic Assessment |
| ||
| Weight gain | Investigations | Systematic Assessment |
| ||
| Weight loss | Investigations | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| White blood cell decreased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Autoimmune hemolytic anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Edema periorbital | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Edematous weight gain | General disorders | Systematic Assessment |
| ||
| Hypoalbuminemia | Hepatobiliary disorders | Systematic Assessment |
| ||
| Macular Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Petechiae | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| White blood cell count increased | Investigations | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Mascarenhas | Icahn School of Medicine at Mount Sinai | 212-241-3417 | john.mascarenhas@mssm.edu |
| Oct 8, 2018 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540383 | ruxolitinib |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Post-ET myelofibrosis |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
| Participants |
|
|
|
|
|