AML-02: Omacetaxine With Standard-of-Care Induction With Cytarabine & Idarubicin in Newly-Diagnosed AML Patients

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Terminated
CT.gov ID
NCT02440568
Collaborator
Teva Pharmaceuticals USA (Industry)
22
1
4
41.9
0.5

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Cytarabine
  • Drug: Idarubicin
  • Drug: Omacetaxine mepesuccinate
  • Drug: Omacetaxine mepesuccinate
  • Drug: Omacetaxine mepesuccinate
  • Drug: Omacetaxine mepesuccinate
Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
AML-02: Study of the Activity and Safety of the Addition of Omacetaxine to the Standard-of-Care Induction Therapy Regimen of Cytarabine and Idarubicin in Newly-Diagnosed AML Patients
Actual Study Start Date :
Jun 5, 2015
Actual Primary Completion Date :
Nov 30, 2018
Actual Study Completion Date :
Nov 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: Omacetaxine at Dose level at 0.625mg/m^2

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.

Drug: Cytarabine
Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.
Other Names:
  • Cytosine arabinoside, Ara-C, Cytosar
  • Drug: Idarubicin
    Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3.
    Other Names:
  • Idamycin PFS, Idamycin®
  • Drug: Omacetaxine mepesuccinate
    Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 0.625mg/m^2

    Experimental: Cohort 2: Omacetaxine at Dose level at 1.25mg/m^

    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.

    Drug: Cytarabine
    Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.
    Other Names:
  • Cytosine arabinoside, Ara-C, Cytosar
  • Drug: Idarubicin
    Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3.
    Other Names:
  • Idamycin PFS, Idamycin®
  • Drug: Omacetaxine mepesuccinate
    Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 1.25mg/m^2

    Experimental: Cohort 3: Omacetaxine at Dose level at 2.0mg/m^

    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.

    Drug: Cytarabine
    Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.
    Other Names:
  • Cytosine arabinoside, Ara-C, Cytosar
  • Drug: Idarubicin
    Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3.
    Other Names:
  • Idamycin PFS, Idamycin®
  • Drug: Omacetaxine mepesuccinate
    Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 2.0mg/m^2

    Experimental: Cohort 4: Omacetaxine at Dose level at 3.0mg/m^

    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.

    Drug: Cytarabine
    Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.
    Other Names:
  • Cytosine arabinoside, Ara-C, Cytosar
  • Drug: Idarubicin
    Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3.
    Other Names:
  • Idamycin PFS, Idamycin®
  • Drug: Omacetaxine mepesuccinate
    Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 3.0mg/m^2

    Outcome Measures

    Primary Outcome Measures

    1. Optimally Tolerated Dose [Within 50 days (duration of hematologic recovery)]

      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).

    Secondary Outcome Measures

    1. Toxicity: Describe by the Adverse Events as Assessed by the CTCAE Grading [Up to 6 months after last dose of Omacetaxine]

      Describe the adverse events associated with Omacetaxine when administered in combination with cytarabine and Idarubicin as induction therapy for AML, using CTCAE grading

    2. Time to Hematologic Recovery [Within 6 months of last dose of Omacetaxine]

      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.

    3. Overall Participant Survival [3 years]

      Observed overall survival among participants (days)

    4. Event Free Survival [6 months]

      Observed length of time (days) after which patients remained free of recurrence or death.

    5. Progression Free Survival [3 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. 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.

    2. Patients age 18 to 70 years old who meet diagnostic criteria for AML according to the WHO classification for AML.

    3. 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.

    4. ECOG performance status of 0-3

    5. 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

    1. 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.

    2. Patients must be willing and able to review, understand, and provide written consent before starting therapy.

    Exclusion Criteria:
    1. Acute promyelocytic leukemia.

    2. Investigational drug within 4 weeks of study entry.

    3. Cardiac insufficiency grade III or IV New York Heart Association (NYHA)

    4. Female subjects who are pregnant or breast feeding.

    5. Patients who are HIV positive.

    6. Active uncontrolled infection or severe systemic infection (enrollment is possible after control of infection).

    7. Concurrent malignancy (other than AML) with an estimated life expectancy less than two years and requiring active therapy.

    8. Psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up.

    9. Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or medically relevant active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.

    10. Pregnant or breastfeeding: Omacetaxine is a Pregnancy Category D medication and has caused embryo-fetal death in animals. Confirmation that the subject is not pregnant must be established by a negative urine β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.

    11. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Illinois at Chicago Chicago Illinois United States 60612

    Sponsors and Collaborators

    • University of Illinois at Chicago
    • Teva Pharmaceuticals USA

    Investigators

    • Principal Investigator: John Quigley, MD, University of Illinois at Chicago

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    John Quigley, Principal Investigator, University of Illinois at Chicago
    ClinicalTrials.gov Identifier:
    NCT02440568
    Other Study ID Numbers:
    • 2015-0181
    • 2015-0181
    First Posted:
    May 12, 2015
    Last Update Posted:
    Jul 6, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Patients With Newly Diagnosed AML, Cohort 1 Patients With Newly Diagnosed AML, Cohort 2 Patients With Newly Diagnosed AML, Cohort 3 Patients With Newly Diagnosed AML, Cohort 4
    Arm/Group Description 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. 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. 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. 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.
    Period Title: Overall Study
    STARTED 5 4 10 3
    COMPLETED 1 1 5 1
    NOT COMPLETED 4 3 5 2

    Baseline Characteristics

    Arm/Group Title Patients With Newly Diagnosed AML Cohort 1 Patients With Newly Diagnosed AML Cohort 2 Patients With Newly Diagnosed AML Cohort 3 Patients With Newly Diagnosed AML Cohort 4 Total
    Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
    Overall Participants 5 4 10 3 22
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    5
    100%
    4
    100%
    7
    70%
    2
    66.7%
    18
    81.8%
    >=65 years
    0
    0%
    0
    0%
    3
    30%
    1
    33.3%
    4
    18.2%
    Sex: Female, Male (Count of Participants)
    Female
    2
    40%
    2
    50%
    7
    70%
    2
    66.7%
    13
    59.1%
    Male
    3
    60%
    2
    50%
    3
    30%
    1
    33.3%
    9
    40.9%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    20%
    1
    25%
    4
    40%
    0
    0%
    6
    27.3%
    Not Hispanic or Latino
    4
    80%
    3
    75%
    6
    60%
    3
    100%
    16
    72.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    2
    40%
    0
    0%
    0
    0%
    0
    0%
    2
    9.1%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    20%
    1
    25%
    3
    30%
    1
    33.3%
    6
    27.3%
    White
    2
    40%
    3
    75%
    7
    70%
    2
    66.7%
    14
    63.6%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    5
    100%
    4
    100%
    10
    100%
    3
    100%
    22
    100%

    Outcome Measures

    1. Primary Outcome
    Title Optimally Tolerated Dose
    Description 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).
    Time Frame Within 50 days (duration of hematologic recovery)

    Outcome Measure Data

    Analysis Population Description
    Number of participants in each cohort
    Arm/Group Title Patients With Newly Diagnosed AML, Cohort 1 Patients With Newly Diagnosed AML, Cohort 2 Patients With Newly Diagnosed AML, Cohort 3 Patients With Newly Diagnosed AML, Cohort 4
    Arm/Group Description 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 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. 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 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. 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. 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.
    Measure Participants 5 4 10 3
    Number [Participants treated with OD]
    0
    0%
    0
    0%
    10
    100%
    0
    0%
    2. Secondary Outcome
    Title Toxicity: Describe by the Adverse Events as Assessed by the CTCAE Grading
    Description Describe the adverse events associated with Omacetaxine when administered in combination with cytarabine and Idarubicin as induction therapy for AML, using CTCAE grading
    Time Frame Up to 6 months after last dose of Omacetaxine

    Outcome Measure Data

    Analysis Population Description
    All patients enrolled into the study
    Arm/Group Title Patients With Newly Diagnosed AML, Cohort 1 Patients With Newly Diagnosed AML, Cohort 2 Patients With Newly Diagnosed AML, Cohort 3 Patients With Newly Diagnosed AML, Cohort 4
    Arm/Group Description 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 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. 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 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. 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. 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.
    Measure Participants 5 4 10 3
    Number [Total Adverse Events]
    47
    88
    219
    37
    3. Secondary Outcome
    Title Time to Hematologic Recovery
    Description 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.
    Time Frame Within 6 months of last dose of Omacetaxine

    Outcome Measure Data

    Analysis Population Description
    Patients who achieved a CR/CRi when treated with the study medications.
    Arm/Group Title Patients With Newly Diagnosed AML, Cohort 1 Patients With Newly Diagnosed AML, Cohort 2 Patients With Newly Diagnosed AML, Cohort 3 Patients With Newly Diagnosed AML, Cohort 4
    Arm/Group Description 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 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. 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 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. 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. 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.
    Measure Participants 2 3 4 1
    Median (Full Range) [Days]
    25.5
    35
    33.5
    36
    4. Secondary Outcome
    Title Overall Participant Survival
    Description Observed overall survival among participants (days)
    Time Frame 3 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Patients With Newly Diagnosed AML, Cohort 1 Patients With Newly Diagnosed AML, Cohort 2 Patients With Newly Diagnosed AML, Cohort 3 Patients With Newly Diagnosed AML, Cohort 4
    Arm/Group Description 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 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. 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 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. 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. 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.
    Measure Participants 5 4 10 3
    Median (Inter-Quartile Range) [Days]
    726
    162.5
    792.5
    33
    5. Secondary Outcome
    Title Event Free Survival
    Description Observed length of time (days) after which patients remained free of recurrence or death.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Patients With Newly Diagnosed AML, Cohort 1 Patients With Newly Diagnosed AML, Cohort 2 Patients With Newly Diagnosed AML, Cohort 3 Patients With Newly Diagnosed AML, Cohort 4
    Arm/Group Description 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 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. 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 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. 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. 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.
    Measure Participants 5 4 10 3
    Median (Inter-Quartile Range) [Days]
    66
    90.5
    65.5
    33
    6. Secondary Outcome
    Title Progression Free Survival
    Description 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.
    Time Frame 3 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Patients With Newly Diagnosed AML, Cohort 1 Patients With Newly Diagnosed AML, Cohort 2 Patients With Newly Diagnosed AML, Cohort 3 Patients With Newly Diagnosed AML, Cohort 4
    Arm/Group Description 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 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. 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 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. 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. 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.
    Measure Participants 2 3 4 1
    Median (Full Range) [Days]
    852.5
    100
    1241.5
    1141

    Adverse Events

    Time Frame Adverse Events were assessed for 1 year
    Adverse Event Reporting Description All-Cause Mortality was assessed for 3 years
    Arm/Group Title Patients With Newly Diagnosed AML, Cohort 1 Patients With Newly Diagnosed AML, Cohort 2 Patients With Newly Diagnosed AML, Cohort 3 Patients With Newly Diagnosed AML, Cohort 4
    Arm/Group Description 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. 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 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 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
    All Cause Mortality
    Patients With Newly Diagnosed AML, Cohort 1 Patients With Newly Diagnosed AML, Cohort 2 Patients With Newly Diagnosed AML, Cohort 3 Patients With Newly Diagnosed AML, Cohort 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/5 (40%) 3/4 (75%) 4/10 (40%) 2/3 (66.7%)
    Serious Adverse Events
    Patients With Newly Diagnosed AML, Cohort 1 Patients With Newly Diagnosed AML, Cohort 2 Patients With Newly Diagnosed AML, Cohort 3 Patients With Newly Diagnosed AML, Cohort 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/5 (40%) 3/4 (75%) 4/10 (40%) 2/3 (66.7%)
    Blood and lymphatic system disorders
    Death 2/5 (40%) 2 3/4 (75%) 3 4/10 (40%) 4 2/3 (66.7%) 2
    Other (Not Including Serious) Adverse Events
    Patients With Newly Diagnosed AML, Cohort 1 Patients With Newly Diagnosed AML, Cohort 2 Patients With Newly Diagnosed AML, Cohort 3 Patients With Newly Diagnosed AML, Cohort 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/5 (100%) 4/4 (100%) 10/10 (100%) 3/3 (100%)
    Blood and lymphatic system disorders
    Hypervolemia 0/5 (0%) 0 1/4 (25%) 1 2/10 (20%) 2 0/3 (0%) 0
    Anemia 1/5 (20%) 1 0/4 (0%) 0 5/10 (50%) 5 0/3 (0%) 0
    Edema to lims 1/5 (20%) 1 2/4 (50%) 2 3/10 (30%) 3 0/3 (0%) 0
    Facial edema 1/5 (20%) 1 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Febrile neutropenia 3/5 (60%) 3 4/4 (100%) 4 9/10 (90%) 9 2/3 (66.7%) 2
    Increased INR 0/5 (0%) 0 0/4 (0%) 0 5/10 (50%) 5 1/3 (33.3%) 1
    Increased PTT 0/5 (0%) 0 0/4 (0%) 0 4/10 (40%) 4 0/3 (0%) 0
    Cardiac disorders
    Sinus tachycardia 0/5 (0%) 0 0/4 (0%) 0 6/10 (60%) 6 1/3 (33.3%) 1
    Pericardial effusion 1/5 (20%) 1 0/4 (0%) 0 1/10 (10%) 1 1/3 (33.3%) 1
    Acute coronary syndrom 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Atrial fibrillation 0/5 (0%) 0 1/4 (25%) 1 1/10 (10%) 1 1/3 (33.3%) 1
    Atrial flutter 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Paroxysmal atrial tachycardia 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Syncope 0/5 (0%) 0 0/4 (0%) 0 0/10 (0%) 0 1/3 (33.3%) 1
    Ear and labyrinth disorders
    Epistaxis 1/5 (20%) 1 1/4 (25%) 1 0/10 (0%) 0 0/3 (0%) 0
    Eye disorders
    Blurred vision 0/5 (0%) 0 2/4 (50%) 2 0/10 (0%) 0 0/3 (0%) 0
    Rentinal tear 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Gastrointestinal disorders
    Anorexia 0/5 (0%) 0 2/4 (50%) 2 4/10 (40%) 4 0/3 (0%) 0
    Weight gain 1/5 (20%) 1 0/4 (0%) 0 2/10 (20%) 2 0/3 (0%) 0
    Weight loss 1/5 (20%) 1 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Nausea 3/5 (60%) 3 4/4 (100%) 4 6/10 (60%) 6 1/3 (33.3%) 1
    Vomiting 2/5 (40%) 2 4/4 (100%) 4 6/10 (60%) 6 1/3 (33.3%) 1
    Diarrhea 2/5 (40%) 2 2/4 (50%) 2 6/10 (60%) 6 0/3 (0%) 0
    Abdominal pain 0/5 (0%) 0 3/4 (75%) 3 4/10 (40%) 4 1/3 (33.3%) 1
    Constipation 1/5 (20%) 1 2/4 (50%) 2 2/10 (20%) 2 0/3 (0%) 0
    Oral mucositis 0/5 (0%) 0 1/4 (25%) 1 5/10 (50%) 5 1/3 (33.3%) 1
    Abdominal distension 0/5 (0%) 0 0/4 (0%) 0 2/10 (20%) 2 1/3 (33.3%) 1
    Dyspepsia 1/5 (20%) 1 1/4 (25%) 1 1/10 (10%) 1 0/3 (0%) 0
    Oral pain 1/5 (20%) 1 2/4 (50%) 2 1/10 (10%) 1 0/3 (0%) 0
    Dysphagia 1/5 (20%) 1 1/4 (25%) 1 1/10 (10%) 1 0/3 (0%) 0
    Esophagitis 0/5 (0%) 0 1/4 (25%) 1 2/10 (20%) 2 0/3 (0%) 0
    Anal pain 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Dry mouth 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 1/3 (33.3%) 1
    Esophageal infection 1/5 (20%) 1 0/4 (0%) 0 2/10 (20%) 2 0/3 (0%) 0
    Hypophosphemia 0/5 (0%) 0 0/4 (0%) 0 2/10 (20%) 2 1/3 (33.3%) 1
    Anal hemorrhage 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Bloody stool 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Gastric bleeding 0/5 (0%) 0 0/4 (0%) 0 2/10 (20%) 2 0/3 (0%) 0
    General disorders
    Fatigue 0/5 (0%) 0 2/4 (50%) 2 4/10 (40%) 4 0/3 (0%) 0
    Pain 1/5 (20%) 1 0/4 (0%) 0 2/10 (20%) 2 0/3 (0%) 0
    Multiorgan failure 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Dizziness 0/5 (0%) 0 2/4 (50%) 2 0/10 (0%) 0 0/3 (0%) 0
    Hepatobiliary disorders
    Ascities 0/5 (0%) 0 0/4 (0%) 0 0/10 (0%) 0 1/3 (33.3%) 1
    Cholecystitis 0/5 (0%) 0 2/4 (50%) 2 2/10 (20%) 2 0/3 (0%) 0
    Increased alanine aminotransferase 1/5 (20%) 1 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Increased aspartate aminotransferase 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Increased blood bilirubin 1/5 (20%) 1 0/4 (0%) 0 2/10 (20%) 2 0/3 (0%) 0
    Immune system disorders
    Infusion related reaction 0/5 (0%) 0 1/4 (25%) 1 0/10 (0%) 0 0/3 (0%) 0
    Infections and infestations
    Chills 3/5 (60%) 3 2/4 (50%) 2 2/10 (20%) 2 0/3 (0%) 0
    Sepsis 1/5 (20%) 1 1/4 (25%) 1 3/10 (30%) 3 2/3 (66.7%) 2
    Septic emboli 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Fever 1/5 (20%) 1 2/4 (50%) 2 1/10 (10%) 1 0/3 (0%) 0
    Metabolism and nutrition disorders
    Hyperglycemia 1/5 (20%) 1 2/4 (50%) 2 5/10 (50%) 5 1/3 (33.3%) 1
    Hypernatremia 1/5 (20%) 1 2/4 (50%) 2 5/10 (50%) 5 1/3 (33.3%) 1
    Hyponatremia 0/5 (0%) 0 2/4 (50%) 2 3/10 (30%) 3 1/3 (33.3%) 1
    Hypoalbuminemia 1/5 (20%) 1 0/4 (0%) 0 6/10 (60%) 6 0/3 (0%) 0
    Hypomagnesemia 0/5 (0%) 0 0/4 (0%) 0 2/10 (20%) 2 0/3 (0%) 0
    Hypokalemia 0/5 (0%) 0 0/4 (0%) 0 2/10 (20%) 2 0/3 (0%) 0
    Hypercalcemia 0/5 (0%) 0 0/4 (0%) 0 2/10 (20%) 2 0/3 (0%) 0
    Hypocalcemia 0/5 (0%) 0 0/4 (0%) 0 2/10 (20%) 2 1/3 (33.3%) 1
    Metabolic acidosis 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 2/3 (66.7%) 2
    Increased alkaline phosphatse 1/5 (20%) 1 1/4 (25%) 1 1/10 (10%) 1 0/3 (0%) 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity 1/5 (20%) 1 1/4 (25%) 1 5/10 (50%) 5 0/3 (0%) 0
    Generalized muscle weakness 2/5 (40%) 2 1/4 (25%) 1 0/10 (0%) 0 0/3 (0%) 0
    Back pain 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 1/3 (33.3%) 1
    Non-cardiac chest pain 0/5 (0%) 0 1/4 (25%) 1 3/10 (30%) 3 1/3 (33.3%) 1
    Neck pain 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Nervous system disorders
    Headache 2/5 (40%) 2 1/4 (25%) 1 5/10 (50%) 5 0/3 (0%) 0
    Depressed level of consciousness 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 1/3 (33.3%) 1
    Dysarthria 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Neuropathy 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Somnolence 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Seizure 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Stroke 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Confusion 0/5 (0%) 0 1/4 (25%) 1 1/10 (10%) 1 0/3 (0%) 0
    Delirium 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 1/3 (33.3%) 1
    Psychiatric disorders
    Anxiety 0/5 (0%) 0 1/4 (25%) 1 1/10 (10%) 1 0/3 (0%) 0
    Insomnia 0/5 (0%) 0 1/4 (25%) 1 3/10 (30%) 3 0/3 (0%) 0
    Depression 0/5 (0%) 0 1/4 (25%) 1 0/10 (0%) 0 0/3 (0%) 0
    Psychosis 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Renal and urinary disorders
    Urinary tract infection 1/5 (20%) 1 1/4 (25%) 1 0/10 (0%) 0 1/3 (33.3%) 1
    Acute kidney injury 0/5 (0%) 0 1/4 (25%) 1 3/10 (30%) 3 2/3 (66.7%) 2
    Decreased urinary output 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Reproductive system and breast disorders
    Vulvlar abscess 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Breast pain 0/5 (0%) 0 0/4 (0%) 0 0/10 (0%) 0 1/3 (33.3%) 1
    Vaginal bleeding 0/5 (0%) 0 0/4 (0%) 0 3/10 (30%) 3 0/3 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 2/5 (40%) 2 1/4 (25%) 1 2/10 (20%) 2 1/3 (33.3%) 1
    Pulmonary edema 1/5 (20%) 1 1/4 (25%) 1 4/10 (40%) 4 1/3 (33.3%) 1
    Pulmonary hypertension 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Cough 0/5 (0%) 0 2/4 (50%) 2 2/10 (20%) 2 0/3 (0%) 0
    Hypoxia 0/5 (0%) 0 1/4 (25%) 1 2/10 (20%) 2 2/3 (66.7%) 2
    Pleural effusion 0/5 (0%) 0 1/4 (25%) 1 1/10 (10%) 1 0/3 (0%) 0
    Productive cough 0/5 (0%) 0 1/4 (25%) 1 0/10 (0%) 0 0/3 (0%) 0
    Respiratory failure 0/5 (0%) 0 1/4 (25%) 1 1/10 (10%) 1 1/3 (33.3%) 1
    Sore throat 0/5 (0%) 0 2/4 (50%) 2 1/10 (10%) 1 0/3 (0%) 0
    Wheezing 0/5 (0%) 0 0/4 (0%) 0 2/10 (20%) 2 0/3 (0%) 0
    Respiratory infection 0/5 (0%) 0 0/4 (0%) 0 2/10 (20%) 2 1/3 (33.3%) 1
    Skin and subcutaneous tissue disorders
    Skin infection 0/5 (0%) 0 1/4 (25%) 1 1/10 (10%) 1 0/3 (0%) 0
    Rash Maculo-papular 1/5 (20%) 1 1/4 (25%) 1 4/10 (40%) 4 0/3 (0%) 0
    Alopecia 1/5 (20%) 1 0/4 (0%) 0 0/10 (0%) 0 0/3 (0%) 0
    Erythema multiforne 0/5 (0%) 0 1/4 (25%) 1 0/10 (0%) 0 0/3 (0%) 0
    Skin hyperpigmentation 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Skin ulceration 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 1/3 (33.3%) 1
    Bullous dermatitis 0/5 (0%) 0 0/4 (0%) 0 1/10 (10%) 1 0/3 (0%) 0
    Vascular disorders
    Hypertension 1/5 (20%) 1 1/4 (25%) 1 3/10 (30%) 3 0/3 (0%) 0
    Hypotension 0/5 (0%) 0 1/4 (25%) 1 2/10 (20%) 2 1/3 (33.3%) 1
    Hematoma 0/5 (0%) 0 1/4 (25%) 1 1/10 (10%) 1 0/3 (0%) 0
    Thromboembolic event 1/5 (20%) 1 0/4 (0%) 0 2/10 (20%) 2 0/3 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. John Quigley
    Organization University of Illinois at Chicago
    Phone 312-413-1300
    Email seanq@uic.edu
    Responsible Party:
    John Quigley, Principal Investigator, University of Illinois at Chicago
    ClinicalTrials.gov Identifier:
    NCT02440568
    Other Study ID Numbers:
    • 2015-0181
    • 2015-0181
    First Posted:
    May 12, 2015
    Last Update Posted:
    Jul 6, 2021
    Last Verified:
    Jul 1, 2021