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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-0181 | Other Identifier | University of Illinois at Chicago |
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| Name | Class |
|---|---|
| Teva Pharmaceuticals USA | INDUSTRY |
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This is a dose escalation study to evaluate Omacetaxine when given in combination with a standard induction regimen of "7+3" (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in patients with newly diagnosed acute myelogenous leukemia (AML).
This is a dose escalation study to evaluate Omacetaxine when given in combination with a standard induction regimen of "7+3" (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in patients with newly diagnosed acute myelogenous leukemia (AML). Omacetaxine will be given subcutaneously Q12 hours on Days 1-7. The optimally safe and active dose (OD) will be determined using the EffTox design. EffTox is a Bayesian adaptive design that seeks to determine the optimal dose for further study in Phase II by considering a trade-off between efficacy and toxicity. The EffTox design begins by treating a cohort of three patients at dose level 1. These patients' efficacy and toxicity outcomes are used to update the posterior distributions for the probability of efficacy and toxicity and identify acceptable dose levels. The study terminates if no dose levels are acceptable. Otherwise, the acceptable doses are ranked using the Euclidean distance from (1.0, 0.0) and the next cohort is treated at the dose with the minimum distance under the restriction that we may only escalate or deescalate by one dose level at a time (e.g., the second cohort can only escalate to dose level 2 or deescalate to dose level -1). The second cohort is treated at the dose with the minimum distance and posterior distributions, and the list of acceptable doses and distances are updated as before. This process continues until at least 20 subjects are enrolled in the study. The dose with the minimum distance at study completion is considered the optimal dose for further investigation. If none of the dose levels are acceptable at study completion, an optimal dose level will not be identified and the drug does not warrant further investigation.
Post induction therapy will consist of standard cytarabine consolidation chemotherapy or allogeneic stem cell transplantation based on pretreatment risk assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Omacetaxine at Dose level at 0.625mg/m^2 | Experimental | Patients will receive Omacetaxine at Dose level 0.625mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. |
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| Cohort 2: Omacetaxine at Dose level at 1.25mg/m^ | Experimental | Patients will receive Omacetaxine at Dose level 1.25mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. |
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| Cohort 3: Omacetaxine at Dose level at 2.0mg/m^ | Experimental | Patients will receive Omacetaxine at Dose level 2.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytarabine | Drug | Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Optimally Tolerated Dose | The primary endpoint is determination of the optimally active and safe dose (OD) of Omacetaxine when added to the standard-of-care induction chemotherapy for AML and estimation of the efficacy and response rate. OD will be defined as a dose level at which fewer than 30% of patients experience hematologic toxicity and greater than 50% of patients achieve a CR (50% is an accepted CR rate in AML when using a single induction). | Within 50 days (duration of hematologic recovery) |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity: Describe by the Adverse Events as Assessed by the CTCAE Grading | Describe the adverse events associated with Omacetaxine when administered in combination with cytarabine and Idarubicin as induction therapy for AML, using CTCAE grading | Up to 6 months after last dose of Omacetaxine |
| Time to Hematologic Recovery |
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Inclusion Criteria:
Newly diagnosed, untreated patients with AML according to the WHO classification for AML. Prior short-term therapy (≤7 days) with hydroxyurea, steroids, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors, azacitidine, ATRA), or hematopoietic growth factors is allowed. A single or two-day dose of cytarabine (up to 3 g/m^2) for emergency use is also allowed as prior therapy.
Patients age 18 to 70 years old who meet diagnostic criteria for AML according to the WHO classification for AML.
Previously untreated AML (≥20% blasts). Note that prior short-term therapy (≤7 days) with hydroxyurea, steroids, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors, azacitidine, ATRA), or hematopoietic growth factors is allowed. A single or two-day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
ECOG performance status of 0-3
Adequate organ function, if not suspected to be due to AML, within 14 days of study registration, defined as:
Total bilirubin ≤ 2.0 x ULN (unless due to hemolysis) AST and ALT ≤ 3 X ULN (unless believed to be due to tumor involvement) Serum Creatinine ≤ 1.5 x ULN Creatinine Clearance > 30 ml/min
Negative urine or serum pregnancy test in females. Patients of reproductive potential (males and females) must consent to and practice double-barrier methods of contraception during treatment and for 12 weeks following the last dose of Omacetaxine. Adequate contraception is defined as double-barrier protection (i.e., condom plus spermicide in combination with a diaphragm, cervical/vault cap, or intrauterine device). Birth control pills, birth control patches and/or injections of hormones to prevent pregnancy are not considered an adequate method of preventing pregnancy, and double-barrier protection is required while on study and for 12 weeks after last dose. Patients will be instructed to notify the investigator if pregnancy is discovered either during or within 12 weeks of completing treatment with Omacetaxine. This also applies to male patients whose partners become pregnant while the patient is on study or within the 12 week period after the last dose of study drug.
Patients must be willing and able to review, understand, and provide written consent before starting therapy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Quigley, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Newly Diagnosed AML, Cohort 1 | Patients will receive Omacetaxine 0.625mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2017 |
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| Cohort 4: Omacetaxine at Dose level at 3.0mg/m^ | Experimental | Patients will receive Omacetaxine at Dose level 3.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. |
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| Idarubicin | Drug | Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
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| Omacetaxine mepesuccinate | Drug | Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 0.625mg/m^2 |
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| Omacetaxine mepesuccinate | Drug | Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 1.25mg/m^2 |
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| Omacetaxine mepesuccinate | Drug | Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 2.0mg/m^2 |
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| Omacetaxine mepesuccinate | Drug | Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 3.0mg/m^2 |
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Time to Absolute Neutrophil Count > 1.0 x 10e9/L and Platelet Count > 100 x 10e9/L, whichever was later, for those patients who achieved a remission and achieved these hematologic goals. |
| Within 6 months of last dose of Omacetaxine |
| Overall Participant Survival | Observed overall survival among participants (days) | 3 years |
| Event Free Survival | Observed length of time (days) after which patients remained free of recurrence or death. | 6 months |
| Progression Free Survival | Among the participants who achieved CR,CRi, progression free survival in number of days, i.e. the number of days participants who achieved CR/CRi remained alive and in a remission. | 3 years |
| FG001 | Patients With Newly Diagnosed AML, Cohort 2 | Patients will receive Omacetaxine 1.25mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
| FG002 | Patients With Newly Diagnosed AML, Cohort 3 | Patients will receive Omacetaxine 2.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
| FG003 | Patients With Newly Diagnosed AML, Cohort 4 | Patients will receive Omacetaxine 3.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Newly Diagnosed AML Cohort 1 | Patients will receive Omacetaxine 0.625mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine (at assigned dose level) administered subcutaneously Q12 hours Days 1 to 7. Dose levels include: 0.625, 1.25, 2.0, 3.0, and 4.2 mg/m^2 Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
| BG001 | Patients With Newly Diagnosed AML Cohort 2 | Patients will receive Omacetaxine 1.25mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine (at assigned dose level) administered subcutaneously Q12 hours Days 1 to 7. Dose levels include: 0.625, 1.25, 2.0, 3.0, and 4.2 mg/m^2 Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. |
| BG002 | Patients With Newly Diagnosed AML Cohort 3 | Patients will receive Omacetaxine 2.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine (at assigned dose level) administered subcutaneously Q12 hours Days 1 to 7. Dose levels include: 0.625, 1.25, 2.0, 3.0, and 4.2 mg/m^2 Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. |
| BG003 | Patients With Newly Diagnosed AML Cohort 4 | Patients will receive Omacetaxine 3.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine (at assigned dose level) administered subcutaneously Q12 hours Days 1 to 7. Dose levels include: 0.625, 1.25, 2.0, 3.0, and 4.2 mg/m^2 Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Optimally Tolerated Dose | The primary endpoint is determination of the optimally active and safe dose (OD) of Omacetaxine when added to the standard-of-care induction chemotherapy for AML and estimation of the efficacy and response rate. OD will be defined as a dose level at which fewer than 30% of patients experience hematologic toxicity and greater than 50% of patients achieve a CR (50% is an accepted CR rate in AML when using a single induction). | Number of participants in each cohort | Posted | Number | Participants treated with OD | Within 50 days (duration of hematologic recovery) |
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| Secondary | Toxicity: Describe by the Adverse Events as Assessed by the CTCAE Grading | Describe the adverse events associated with Omacetaxine when administered in combination with cytarabine and Idarubicin as induction therapy for AML, using CTCAE grading | All patients enrolled into the study | Posted | Number | Total Adverse Events | Up to 6 months after last dose of Omacetaxine |
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| Secondary | Time to Hematologic Recovery | Time to Absolute Neutrophil Count > 1.0 x 10e9/L and Platelet Count > 100 x 10e9/L, whichever was later, for those patients who achieved a remission and achieved these hematologic goals. | Patients who achieved a CR/CRi when treated with the study medications. | Posted | Median | Full Range | Days | Within 6 months of last dose of Omacetaxine |
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| Secondary | Overall Participant Survival | Observed overall survival among participants (days) | Posted | Median | Inter-Quartile Range | Days | 3 years |
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| Secondary | Event Free Survival | Observed length of time (days) after which patients remained free of recurrence or death. | Posted | Median | Inter-Quartile Range | Days | 6 months |
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| Secondary | Progression Free Survival | Among the participants who achieved CR,CRi, progression free survival in number of days, i.e. the number of days participants who achieved CR/CRi remained alive and in a remission. | Posted | Median | Full Range | Days | 3 years |
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Adverse Events were assessed for 1 year
All-Cause Mortality was assessed for 3 years
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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 | Patients With Newly Diagnosed AML, Cohort 1 | Patients will receive Omacetaxine, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine at Dose level at 0.625mg/m^2 administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. | 2 | 5 | 2 | 5 | 5 | 5 |
| EG001 | Patients With Newly Diagnosed AML, Cohort 2 | Patients will receive Omacetaxine, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine at Dose level at 1.25mg/m^2 administered | 3 | 4 | 3 | 4 | 4 | 4 |
| EG002 | Patients With Newly Diagnosed AML, Cohort 3 | Patients will receive Omacetaxine, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine at Dose level at 2.0mg/m^2 administered | 4 | 10 | 4 | 10 | 10 | 10 |
| EG003 | Patients With Newly Diagnosed AML, Cohort 4 | Patients will receive Omacetaxine, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine at Dose level at 3.0mg/m^2 administered | 2 | 3 | 2 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Progression of disease |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Infusion related reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
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| Multiorgan failure | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Weight gain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Weight loss | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypervolemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Edema to lims | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Facial edema | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Oral mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Anal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Ascities | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Epistaxis | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Acute coronary syndrom | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Paroxysmal atrial tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Septic emboli | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Respiratory infection | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Esophageal infection | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Skin infection | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Vulvlar abscess | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| Rash Maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Erythema multiforne | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Bullous dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphemia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Increased alkaline phosphatse | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Increased alanine aminotransferase | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Increased aspartate aminotransferase | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Increased blood bilirubin | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Increased INR | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Increased PTT | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Decreased urinary output | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bloody stool | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vaginal bleeding | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastric bleeding | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Delirium | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Psychosis | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rentinal tear | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Quigley | University of Illinois at Chicago | 312-413-1300 | seanq@uic.edu |
| Dec 10, 2020 |
| Prot_SAP_000.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 |
|---|---|
| D003561 | Cytarabine |
| D015255 | Idarubicin |
| D000077863 | Homoharringtonine |
| ID | Term |
|---|---|
| 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 |
| 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 |
| D006248 | Harringtonines |
| D000470 | Alkaloids |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Patients With Newly Diagnosed AML, Cohort 3 | Patients will receive Omacetaxine 2.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
| OG003 | Patients With Newly Diagnosed AML, Cohort 4 | Patients will receive Omacetaxine 3.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
|
|
| OG002 | Patients With Newly Diagnosed AML, Cohort 3 | Patients will receive Omacetaxine 2.0g/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
| OG003 | Patients With Newly Diagnosed AML, Cohort 4 | Patients will receive Omacetaxine 3.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
|
|
| OG002 | Patients With Newly Diagnosed AML, Cohort 3 | Patients will receive Omacetaxine 2.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
| OG003 | Patients With Newly Diagnosed AML, Cohort 4 | Patients will receive Omacetaxine 3.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
|
|
| OG002 | Patients With Newly Diagnosed AML, Cohort 3 | Patients will receive Omacetaxine 2.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
| OG003 | Patients With Newly Diagnosed AML, Cohort 4 | Patients will receive Omacetaxine 3.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
|
|
| OG002 | Patients With Newly Diagnosed AML, Cohort 3 | Patients will receive Omacetaxine 2.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
| OG003 | Patients With Newly Diagnosed AML, Cohort 4 | Patients will receive Omacetaxine 3.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Omacetaxine: Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Cytarabine: Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. Idarubicin: Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. |
|
|