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This was an exploratory Phase 2, open label, randomized, multicenter, parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, "7+3") and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.
The primary efficacy endpoint was to assess whether dociparstat in conjunction with standard induction therapy for AML increased the complete remission rate based on the International Working Group AML response criteria.
A total of 75 subjects were to be randomized in a 1:1:1 ratio to 1 of the following treatment groups:
Subjects received up to 2 induction cycles and up to 2 consolidation cycles and participated in the study for up to 18 months. Clinical laboratory tests were conducted routinely, and bone marrow aspirates and biopsies were performed during the induction cycles. Safety was monitored through adverse events and clinical laboratory results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (idarubicin+cytarabine) | Active Comparator | Induction:
Re-induction:
Consolidation: • Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5) |
|
| Dociparstat 0.125 mg/kg | Experimental | Induction:
Re-induction:
Consolidation:
|
|
| Dociparstat 0.25 mg/kg | Experimental | Induction:
Re-induction:
Consolidation:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dociparstat sodium | Drug | Subjects received 4 mg/kg dociparstat intravenous (IV) bolus followed by doses of 0.125 or 0.25 mg/kg/hr dociparstat given on Days 1 through 7 with standard induction therapy, on Days 1 through 5 or 7 with standard re-induction therapy, and on Days 1, 3, and 5 with standard consolidation therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Achieved Morphologic Complete Remission | Morphologic complete remission (CR) was evaluated by International Working Group (IWG) criteria and defined as absolute neutrophil count (ANC) >1000/microliter; platelet count >100,000, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. | During induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Event-free Survival | Event-free survival was measured as date of randomization until treatment failure. Treatment failure was defined as failure to achieve composite completed morphological remission during the induction and re-induction phase of the study lasting up to 60 days, relapse from complete response, or death from any cause, whichever occurred first. | Randomization up to 30 months |
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Inclusion Criteria:
Subjects had to meet all the following criteria to be eligible for enrollment in this study:
Exclusion Criteria:
Subjects who met any of the following criteria were not eligible for enrollment in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Marcus, MD | Cantex Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego, Moores Cancer Center | La Jolla | California | 92093 | United States | ||
Note that 2 randomized subjects did not receive study treatment: 1 subject in the control group and 1 subject in the dociparstat 0.25 mg/kg group. Therefore, these 2 subjects are not included in the safety analysis, but are included in the efficacy analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (Idarubicin+Cytarabine) | Induction:
Reinduction:
Consolidation: • Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, 5) |
| 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 | Yes | No | No | Study Protocol | Jan 13, 2017 | Aug 23, 2021 |
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|
|
|
| Idarubicin | Drug | Subjects received 12 mg/m2/day idarubicin by slow (10 to 15 minutes) intravenous (IV) injection daily on Days 1, 2 and 3 of induction therapy, and on Days 1 and 2 of re-induction therapy. |
|
|
| Cytarabine | Drug | Subjects received 100 mg/m2/day cytarabine by continuous intravenous (IV) infusion on Days 1 through 7 of induction therapy and on Days 1 through 5 of re-induction therapy. During consolidation therapy, subjected received 1.0 g/m2 cytarabine IV infusion given over 3 hours every 12 hours on Days 1, 3, and 5. |
|
| Time to Leukemia-free Survival | Leukemia-free survival was assessed as a secondary endpoint only in subjects who achieved composite complete remission and was measured from randomization until disease relapse or death from any cause, whichever occurred first. Assessments were performed every 3 months until death or 18 months after the last subject was randomized, whichever occurred first. | Randomization until disease relapse or patient death from any cause, whichever occurs first, assessed up to 30 months |
| Number of Subjects Who Achieved Overall Survival | Overall survival was measured from the date of randomization until death from any cause. Assessments were performed every 3 months and continued until death or 18 months after the last patient was randomized, whichever came first. | Randomization to end of study (18 months) |
| Number of Subjects Who Achieved Composite Complete Remission | The composite complete remission (CR) rate included CR, CR without recovery of platelets (CRp), and CR without recovery of neutrophils and/or platelets (CRi), as defined by the International Working Group criteria during the induction and re-induction phases of treatment. CR was defined as an Absolute Neutrophil Count (ANC) >1000/μL, platelet count >100,000/μL, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. CRi was defined as an ANC <1000/μL and/or platelet count <100,000/, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. | Up to 60 days after the start of each treatment cycle |
| Duration of Morphologic Complete Remission | The duration of morphologic complete remission was assessed only in subjects who had achieved morphologic complete remission and was defined as the time from achievement of complete response to the detection or relapse. Relapse was defined as the reappearance of leukemia blasts in the peripheral blood, >5% blasts in the bone marrow not attributable to another cause, or appearance/reappearance of extramedullary disease and with a bone marrow blast percentage of >5% but ≤20%. If the latter, a repeat bone marrow examination was performed at least 7 days after the first marrow examination; documentation of the bone marrow blast percentage of >5% was necessary to establish relapse. Assessments were performed every 3 months and continued until death or 18 months after the last subject was randomized, whichever occurred first. Duration of morphologic complete remission (time from the achievement of complete response to the detection of relapse) | Randomization to end of study (18 months) |
| Time to Recovery of Neutrophils | Neutrophil recovery was assessed from randomization to Absolute Neutrophil Count (ANC) recovery (ANC >500/µL and >1000/µL) for up to 60 days after the start of each treatment cycle. | Randomization to ANC recovery, for up to 60 days after the start of each treatment cycle |
| Time to Platelet Recovery | Platelet recovery was measured from randomization to platelet recovery (platelet count >20,000/µL and >100,000/µL) | Randomization to platelet recovery, for up to 60 days after the start of each treatment cycle |
| Number of Subjects Who Died by Day 30 | Mortality (rate of death) of subjects by Day 30, measured from the first day of induction treatment to 30 days post-induction. | 30 days (from first day of induction treatment to 30 days after) |
| Number of Subjects Who Died by Day 60. | Mortality (rate of death) of subjects by Day 60, measured from the first day of induction treatment to 60 days post-induction. | 60 days (from the first day of induction treatment to 60 days after) |
| Number of Subjects Who Died by Day 90 | Mortality (rate of death) of subjects at Day 90, measured from the first day of induction treatment to 90 days post-induction. | 90 days (from the first day of induction treatment to 90 days after) |
| Colorado Blood Cancer Institute |
| Denver |
| Colorado |
| 80218 |
| United States |
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
| Franciscan St. Francis Health | Indianapolis | Indiana | 46237 | United States |
| June E. Nylen Cancer Center | Sioux City | Iowa | 51101 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| Tulane University/Tulane Cancer Center | New Orleans | Louisiana | 70112 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Allina Health - Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | United States |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | United States |
| New Mexico Cancer Care Alliance | Albuquerque | New Mexico | 87131 | United States |
| Northwell Health, Monter Cancer Center | Lake Success | New York | 11042 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Oregon Health & Science University Knight Cancer Institute | Portland | Oregon | 97239 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Tennessee Oncology/Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Baylor Research Institute/Baylor Sammons Cancer Center/Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Methodist Healthcare System of San Antonio | San Antonio | Texas | 78229 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| FG001 | Dociparstat 0.125 mg/kg | Induction:
Reinduction:
Consolidation:
|
| FG002 | Dociparstat 0.25 mg/kg | Induction:
Reinduction:
Consolidation:
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (Idarubicin+Cytarabine) | Induction:
Re-induction:
Consolidation: • Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5) |
| BG001 | Dociparstat 0.125 mg/kg | Induction:
Re-induction:
Consolidation:
|
| BG002 | Dociparstat 0.25 mg/kg | Induction:
Re-induction:
Consolidation:
|
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Acute myeloid leukemia (AML) subtype | Count of Participants | Participants |
| ||||||||||||||||
| Time since acute myeloid leukemia (AML) diagnosis | Mean | Standard Deviation | weeks |
| |||||||||||||||
| Baseline blasts in bone marrow | Mean | Standard Deviation | percentage |
|
| 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 Who Achieved Morphologic Complete Remission | Morphologic complete remission (CR) was evaluated by International Working Group (IWG) criteria and defined as absolute neutrophil count (ANC) >1000/microliter; platelet count >100,000, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. | Posted | Count of Participants | Participants | During induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle) |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Event-free Survival | Event-free survival was measured as date of randomization until treatment failure. Treatment failure was defined as failure to achieve composite completed morphological remission during the induction and re-induction phase of the study lasting up to 60 days, relapse from complete response, or death from any cause, whichever occurred first. | Note: In the Dociparstat 0.125 mg/kg group, fewer than half of the subjects achieved complete CR, and thus were assessed as having an event on Day 1. | Posted | Median | Full Range | days | Randomization up to 30 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Leukemia-free Survival | Leukemia-free survival was assessed as a secondary endpoint only in subjects who achieved composite complete remission and was measured from randomization until disease relapse or death from any cause, whichever occurred first. Assessments were performed every 3 months until death or 18 months after the last subject was randomized, whichever occurred first. | This analysis only included subjects who achieved composite complete remission. The following number of subjects were censored in each treatment group:
| Posted | Median | Full Range | days | Randomization until disease relapse or patient death from any cause, whichever occurs first, assessed up to 30 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Achieved Overall Survival | Overall survival was measured from the date of randomization until death from any cause. Assessments were performed every 3 months and continued until death or 18 months after the last patient was randomized, whichever came first. | Posted | Count of Participants | Participants | Randomization to end of study (18 months) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Achieved Composite Complete Remission | The composite complete remission (CR) rate included CR, CR without recovery of platelets (CRp), and CR without recovery of neutrophils and/or platelets (CRi), as defined by the International Working Group criteria during the induction and re-induction phases of treatment. CR was defined as an Absolute Neutrophil Count (ANC) >1000/μL, platelet count >100,000/μL, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. CRi was defined as an ANC <1000/μL and/or platelet count <100,000/, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. | Posted | Count of Participants | Participants | Up to 60 days after the start of each treatment cycle |
| |||||||||||||||||||||||||||||||||||
| Secondary | Duration of Morphologic Complete Remission | The duration of morphologic complete remission was assessed only in subjects who had achieved morphologic complete remission and was defined as the time from achievement of complete response to the detection or relapse. Relapse was defined as the reappearance of leukemia blasts in the peripheral blood, >5% blasts in the bone marrow not attributable to another cause, or appearance/reappearance of extramedullary disease and with a bone marrow blast percentage of >5% but ≤20%. If the latter, a repeat bone marrow examination was performed at least 7 days after the first marrow examination; documentation of the bone marrow blast percentage of >5% was necessary to establish relapse. Assessments were performed every 3 months and continued until death or 18 months after the last subject was randomized, whichever occurred first. Duration of morphologic complete remission (time from the achievement of complete response to the detection of relapse) | This analysis only included subjects who had achieved morphologic complete remission. The following number of subjects were censored in each treatment group for this analysis; however the full ranges include censored subjects:
| Posted | Median | Full Range | days | Randomization to end of study (18 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Recovery of Neutrophils | Neutrophil recovery was assessed from randomization to Absolute Neutrophil Count (ANC) recovery (ANC >500/µL and >1000/µL) for up to 60 days after the start of each treatment cycle. | The following number of subjects were censored in each treatment group for both analyses (neutrophil recovery to >500/µL and >1000/µL):
| Posted | Median | Full Range | days | Randomization to ANC recovery, for up to 60 days after the start of each treatment cycle |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Platelet Recovery | Platelet recovery was measured from randomization to platelet recovery (platelet count >20,000/µL and >100,000/µL) | The following number of subjects were censored in each treatment group for each analysis (platelet recovery to >20,000µL and >100,000µL):
| Posted | Median | Full Range | days | Randomization to platelet recovery, for up to 60 days after the start of each treatment cycle |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Died by Day 30 | Mortality (rate of death) of subjects by Day 30, measured from the first day of induction treatment to 30 days post-induction. | Posted | Count of Participants | Participants | 30 days (from first day of induction treatment to 30 days after) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Died by Day 60. | Mortality (rate of death) of subjects by Day 60, measured from the first day of induction treatment to 60 days post-induction. | Posted | Count of Participants | Participants | 60 days (from the first day of induction treatment to 60 days after) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Died by Day 90 | Mortality (rate of death) of subjects at Day 90, measured from the first day of induction treatment to 90 days post-induction. | Posted | Count of Participants | Participants | 90 days (from the first day of induction treatment to 90 days after) |
|
From signing informed consent to end of study (up to 30 months)
Note that all-cause mortality was assessed for all randomized participants and adverse events were monitored for only participants who received at least 1 dose of study drug; 2 participants (1 in the control group and 1 in the 0.25 mg/kg dociparstat group) were randomized but did not receive study drug and were therefore not monitored for adverse events.
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 | Control (Idarubicin+Cytarabine) | Induction:
Re-induction:
Consolidation: • Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5) | 14 | 26 | 7 | 25 | 25 | 25 |
| EG001 | Dociparstat 0.125 mg/kg | Induction:
Re-induction:
Consolidation:
| 14 | 25 | 8 | 25 | 25 | 25 |
| EG002 | Dociparstat 0.25 mg/kg | Induction:
Re-induction:
Consolidation:
| 9 | 24 | 13 | 23 | 23 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Chapped lips | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| International normalised ration increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash follicular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
Details of the Study and its results shall not be publicized or published in any form without prior consent of the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Chimerix, Inc. | 919-806-1074 | 101 | dmoore@chimerix.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2018 | Aug 23, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C520325 | N-desulfated,2-O,3-O-desulfated heparin |
| D015255 | Idarubicin |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Secondary |
|
| OG002 | Dociparstat 0.25 mg/kg | Induction:
Re-induction:
Consolidation:
|
|
|
| OG002 | Dociparstat 0.25 mg/kg | Induction:
Re-induction:
Consolidation:
|
|
|
| OG002 | Dociparstat 0.25 mg/kg | Induction:
Re-induction:
Consolidation:
|
|
|
| OG002 | Dociparstat 0.25 mg/kg | Induction:
Re-induction:
Consolidation:
|
|
|
| OG001 | Dociparstat 0.125 mg/kg | Induction:
Re-induction:
Consolidation:
|
| OG002 | Dociparstat 0.25 mg/kg | Induction:
Re-induction:
Consolidation:
|
|
|
| OG002 | Dociparstat 0.25 mg/kg | Induction:
Re-induction:
Consolidation:
|
|
|
| OG002 | Dociparstat 0.25 mg/kg | Induction:
Re-induction:
Consolidation:
|
|
|
| OG002 | Dociparstat 0.25 mg/kg | Induction:
Re-induction:
Consolidation:
|
|
|
| OG002 | Dociparstat 0.25 mg/kg | Induction:
Re-induction:
Consolidation:
|
|
|
| OG002 | Dociparstat 0.25 mg/kg | Induction:
Re-induction:
Consolidation:
|
|
|