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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01444 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000393839 | |||
| NCI-6814 | |||
| UCCRC-13327A | |||
| 13327A | Other Identifier | University of Chicago Comprehensive Cancer Center | |
| 6814 | Other Identifier | CTEP | |
| N01CM62201 | U.S. NIH Grant/Contract | View source | |
| N01CM62207 | U.S. NIH Grant/Contract | View source | |
| P30CA014599 | U.S. NIH Grant/Contract | View source |
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This phase II trial studies the side effects and how well decitabine works in treating patients with myelofibrosis, a cancer of the blood system associated with fibrosis (scar tissue) in the bone marrow that is advanced and for which there is no standard therapy. Decitabine may block the actions of some proteins that are responsible for turning certain genes off in various cancers including myelofibrosis.
PRIMARY OBJECTIVES:
I. To determine response rate (complete and partial responses and hematological improvement) to decitabine in patients with myelofibrosis.
II. To determine the safety of decitabine in patients with myelofibrosis.
SECONDARY OBJECTIVES:
I. To determine the effects of decitabine on specific epigenetic changes including methylation status of specific target genes and gene re-expression.
II. To determine the effect of decitabine on hemoglobin F levels and on the absolute numbers of circulating cluster of differentiation (CD) 34+ progenitor cells and to investigate the potential utility of these markers as a surrogate for biologic activity of decitabine in myeloid metaplasia with myelofibrosis (MMM).
OUTLINE:
Patients receive decitabine subcutaneously (SC) on days 1-5 and 8-12. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (decitabine) | Experimental | Patients receive decitabine SC on days 1-5 and 8-12. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine | Drug | Given SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (Complete Response, Partial Response, or Hematologic Improvement. | Complete response is normalization of counts and transfusion-independence. Partial response is hemoglobin increase to normal levels, multilineage improvement including absolute neutrophil count (ANC) and/or platelets. Hematologic improvement is red cell transfusion-independence or >50% increase in platelet levels. | Up to 36 weeks (6 cycles) |
| Incidence of Toxicities, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 | Percentage of patients experiencing any toxicity, any grade level. Additional details on adverse events are reported in Adverse Events section. | Up to 30 days of last dose of decitabine |
| Measure | Description | Time Frame |
|---|---|---|
| CD34+ Cells | CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously. |
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Inclusion Criteria:
Patients must have histologically or cytologically confirmed myeloid metaplasia with myelofibrosis (this includes all subtypes - chronic idiopathic myelofibrosis or angiogenic myeloid metaplasia, post thrombocythemic and post polycythemic myelofibrosis); patients must have anemia (hemoglobin < 11 g/dL) or palpable splenomegaly (measured in cm from costal margin - to be eligible); patients with palpable splenomegaly must have spleen size documented ultrasonographically as well; they must also meet standard diagnostic criteria for MMM
Patients with morphologic evidence of advanced phases of the disease including accelerated (10-19% blasts) phase or with evidence of evolution to acute leukemia (>= 20% blasts) are also eligible for this study
The Italian Diagnostic Criteria for MMM
Necessary criteria
Optional criteria
Diagnosis of MMM is acceptable if the following combinations are present
Patients may have had prior chemotherapy or radiation therapy including splenic irradiation; prior therapy with erythropoietin, granulocyte-colony stimulating factor (GCSF), other growth factors or androgenic steroids is also permitted; there is no limit to the number of prior regimens received; at least 4 weeks must have elapsed since prior chemo or radiation therapy; at least 2 weeks must have elapsed since growth factor (erythropoietin, GCSF, granulocyte-macrophage colony-stimulating factor [GM-CSF]) or other therapy
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Total bilirubin =< 2mg/dL
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal unless due to disease
Serum creatinine =< 2mg/dL
Patients must not be pregnant or nursing; women of child- bearing potential and men must agree to use an effective contraceptive method; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olatoyosi M Odenike | University of Chicago Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States | ||
| Decatur Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39250708 | Derived | Lin C, Patel AA, Huo D, Karrison T, van Besien K, Godwin J, Sher D, Weiner H, Green M, Wade JL 3rd, Klisovic R, Baer MR, Larson RA, Stock W, Odenike O. A multicenter phase 2 clinical trial of low-dose subcutaneous decitabine in myelofibrosis. Blood Adv. 2024 Nov 26;8(22):5735-5743. doi: 10.1182/bloodadvances.2024013215. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Decitabine | Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12. decitabine : Given SC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Cycle 1, Day 1 |
| CD34+ Cells | CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously. | Cycle 1, Day 5 |
| CD34+ Cells | CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously. | Cycle 1, Day 12 |
| CD34+ Cells | CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously. | Cycle 2, Day 1 |
| CD34+ Cells | CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously. | Cycle 2, Day 5 |
| CD34+ Cells | CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously. | Cycle 2, Day 12 |
| CXCR4 | CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL) | Cycle 1, Day 1 |
| CXCR4 | CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL) | Cycle 1, Day 5 |
| CXCR4 | CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL) | Cycle 1, Day 12 |
| CXCR4 | CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL) | Cycle 2, Day 1 |
| CXCR4 | CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL) | Cycle 2, Day 5 |
| CXCR4 | CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL) | Cycle 2, Day 12 |
| Hemoglobin F | Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples. Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker. | Cycle 1, Day 1 |
| Hemoglobin F | Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples. Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker. | Cycle 1, Day 5 |
| Hemoglobin F | Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples. Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker. | Cycle 1, Day 12 |
| Hemoglobin F | Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples. Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker. | Cycle 2, Day 1 |
| Hemoglobin F | Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples. Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker. | Cycle 2, Day 5 |
| Hemoglobin F | Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples. Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker. | Cycle 2, Day 12 |
| Decatur |
| Illinois |
| 62526 |
| United States |
| NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | 60201 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | United States |
| Central Illinois Hematology Oncology Center | Springfield | Illinois | 62702 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Fort Wayne Medical Oncology and Hematology Inc-Parkview | Fort Wayne | Indiana | 46845 | United States |
| Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46628 | United States |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Oncology Care Associates PLLC | Saint Joseph | Michigan | 49085 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I | Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12. decitabine : Given SC |
| 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 |
| ||||||||||||||||||
| 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 | Response Rate (Complete Response, Partial Response, or Hematologic Improvement. | Complete response is normalization of counts and transfusion-independence. Partial response is hemoglobin increase to normal levels, multilineage improvement including absolute neutrophil count (ANC) and/or platelets. Hematologic improvement is red cell transfusion-independence or >50% increase in platelet levels. | Two patients were non-evaluable for response. | Posted | Number | 90% Confidence Interval | percentage of participants | Up to 36 weeks (6 cycles) |
|
|
| |||||||||||||||||||||||||
| Primary | Incidence of Toxicities, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 | Percentage of patients experiencing any toxicity, any grade level. Additional details on adverse events are reported in Adverse Events section. | Posted | Number | 95% Confidence Interval | percentage of patients | Up to 30 days of last dose of decitabine |
|
| |||||||||||||||||||||||||||
| Secondary | CD34+ Cells | CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously. | One patient had missing data. | Posted | Geometric Mean | 95% Confidence Interval | cells x 10^6/L | Cycle 1, Day 1 |
|
| ||||||||||||||||||||||||||
| Secondary | CD34+ Cells | CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously. | One patient had missing data. | Posted | Geometric Mean | 95% Confidence Interval | cells x 10^6/L | Cycle 1, Day 5 |
|
| ||||||||||||||||||||||||||
| Secondary | CD34+ Cells | CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously. | Three patients had missing data. | Posted | Geometric Mean | 95% Confidence Interval | cells x 10^6/L | Cycle 1, Day 12 |
|
| ||||||||||||||||||||||||||
| Secondary | CD34+ Cells | CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously. | Five patients had missing data. | Posted | Geometric Mean | 95% Confidence Interval | cells x 10^6/L | Cycle 2, Day 1 |
|
| ||||||||||||||||||||||||||
| Secondary | CD34+ Cells | CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously. | Six patients had missing data. | Posted | Geometric Mean | 95% Confidence Interval | cells x 10^6/L | Cycle 2, Day 5 |
|
| ||||||||||||||||||||||||||
| Secondary | CD34+ Cells | CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously. | Six patients had missing data. | Posted | Geometric Mean | 95% Confidence Interval | cells x 10^6/L | Cycle 2, Day 12 |
|
| ||||||||||||||||||||||||||
| Secondary | CXCR4 | CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL) | Four patients had missing data. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Cycle 1, Day 1 |
|
| ||||||||||||||||||||||||||
| Secondary | CXCR4 | CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL) | Three patients had missing data. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Cycle 1, Day 5 |
|
| ||||||||||||||||||||||||||
| Secondary | CXCR4 | CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL) | Three patients had missing data. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Cycle 1, Day 12 |
|
| ||||||||||||||||||||||||||
| Secondary | CXCR4 | CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL) | Seven patients had missing data. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Cycle 2, Day 1 |
|
| ||||||||||||||||||||||||||
| Secondary | CXCR4 | CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL) | Seven patients had missing data. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Cycle 2, Day 5 |
|
| ||||||||||||||||||||||||||
| Secondary | CXCR4 | CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL) | Eleven patients had missing data. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Cycle 2, Day 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Hemoglobin F | Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples. Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker. | Four patients had missing data. | Posted | Mean | 95% Confidence Interval | percentage of HbF | Cycle 1, Day 1 |
|
| ||||||||||||||||||||||||||
| Secondary | Hemoglobin F | Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples. Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker. | Three patients had missing data. | Posted | Mean | 95% Confidence Interval | percentage of HbF | Cycle 1, Day 5 |
|
| ||||||||||||||||||||||||||
| Secondary | Hemoglobin F | Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples. Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker. | Three patients had missing data. | Posted | Mean | 95% Confidence Interval | percentage of HbF | Cycle 1, Day 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Hemoglobin F | Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples. Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker. | Nine patients had missing data. | Posted | Mean | 95% Confidence Interval | percentage of HbF | Cycle 2, Day 1 |
|
| ||||||||||||||||||||||||||
| Secondary | Hemoglobin F | Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples. Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker. | Seven patients had missing data. | Posted | Mean | 95% Confidence Interval | percentage of HbF | Cycle 2, Day 5 |
|
| ||||||||||||||||||||||||||
| Secondary | Hemoglobin F | Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples. Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker. | Seven patients had missing data. | Posted | Mean | 95% Confidence Interval | percentage of HbF | Cycle 2, Day 12 |
|
|
Up to 30 days of last dose of decitabine
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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 | Arm I | Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12. decitabine : Given SC | 15 | 21 | 19 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Blood | Infections and infestations | Non-systematic Assessment |
| ||
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Catheter-related | Infections and infestations | Non-systematic Assessment |
| ||
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Lung (pneumonia) | Infections and infestations | Non-systematic Assessment |
| ||
| Splenic infarct vs hemorrhage/rupture | Vascular disorders | Non-systematic Assessment |
| ||
| Sweet's Syndrome | General disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Esophageal varices hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| General disorders and administration site conditions - Other | General disorders | Non-systematic Assessment |
| ||
| Hematoma | Vascular disorders | Non-systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Infections and infestations - Other | Infections and infestations | Non-systematic Assessment |
| ||
| Lung infection | Infections and infestations | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
| ||
| Oesophageal varices | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Vascular disorders - Other | Vascular disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| White blood cell decreased | Investigations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Alkaline phosphatase increased | Investigations | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Non-systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bruising | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| CD4 lymphocytes decreased | Investigations | Non-systematic Assessment |
| ||
| Chills | General disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Creatinine increased | Investigations | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Edema limbs | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypercalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypermagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| INR increased | Investigations | Non-systematic Assessment |
| ||
| Infections and infestations - Other | Infections and infestations | Non-systematic Assessment |
| ||
| Injection site reaction | General disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Non-systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
| ||
| Oral hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Weight loss | Investigations | Non-systematic Assessment |
| ||
| White blood cell decreased | Investigations | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olatoyosi Odenike, MD | University of Chicago | 773-702-3354 | todenike@medicine.bsd.uchicago.edu |
| 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 |
|---|---|
| D000077209 | Decitabine |
| D007267 | Injections |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
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