Trial Outcomes & Findings for Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS) (NCT NCT01272245)
NCT ID: NCT01272245
Last Updated: 2018-05-30
Results Overview
Complete response (CR) defined as: Peripheral blood counts, no circulating blasts, neutrophil count ≥ 1.0 ×109/L, platelet count ≥ 100 ×109/L, bone marrow aspirate and biopsy, ≤5% blasts, no detectable auer rods, no extramedulary leukemia
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Up to 4 months
Results posted on
2018-05-30
Participant Flow
Recruitment Period: 7/14/2011through 1/9/2015. All participants recruited at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Omacetaxine and Cytarabine
Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Baseline characteristics by cohort
| Measure |
Omacetaxine and Cytarabine
n=36 Participants
Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
|
|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 Count of Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 monthsComplete response (CR) defined as: Peripheral blood counts, no circulating blasts, neutrophil count ≥ 1.0 ×109/L, platelet count ≥ 100 ×109/L, bone marrow aspirate and biopsy, ≤5% blasts, no detectable auer rods, no extramedulary leukemia
Outcome measures
| Measure |
Omacetaxine and Cytarabine
n=36 Participants
Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
|
|---|---|
|
Percentage of Participants With Complete Remission (CR)
|
44 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.The date of Complete Response to the date of loss of response or last follow-up.
Outcome measures
| Measure |
Omacetaxine and Cytarabine
n=16 Participants
Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
|
|---|---|
|
Evaluation of CR Duration
|
10.6 Months
Interval 1.5 to 64.7
|
SECONDARY outcome
Timeframe: Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.Time from date of treatment start until the date of first objective documentation of disease-relapse.
Outcome measures
| Measure |
Omacetaxine and Cytarabine
n=36 Participants
Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
|
|---|---|
|
Disease-free Survival
|
3.1 Months
Interval 0.2 to 66.9
|
SECONDARY outcome
Timeframe: Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.Time from date of treatment start until date of death due to any cause
Outcome measures
| Measure |
Omacetaxine and Cytarabine
n=36 Participants
Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
|
|---|---|
|
Overall Survival
|
8.1 Months
Interval 0.2 to 66.9
|
SECONDARY outcome
Timeframe: Up to 1 yearDeath within 8 weeks from the start of treatment.
Outcome measures
| Measure |
Omacetaxine and Cytarabine
n=36 Participants
Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
|
|---|---|
|
Induction Mortality
|
4 Participants
|
Adverse Events
Omacetaxine and Cytarabine
Serious events: 20 serious events
Other events: 15 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Omacetaxine and Cytarabine
n=36 participants at risk
Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
|
|---|---|
|
Cardiac disorders
Acute Coronary Syndrome
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Atrial Fibrillation
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Cardiac Arrest
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Heart Failure
|
2.8%
1/36 • Number of events 1
|
|
Eye disorders
Scleral Disorder
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Rectal Bleeding
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Back Pain
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Death
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Fall
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Fever
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Cholecystitis
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Fever/Infection and Infestation
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Joint Infection
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Lung Infection
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
Neutropenic Fever
|
25.0%
9/36 • Number of events 12
|
|
Infections and infestations
Sepsis
|
8.3%
3/36 • Number of events 3
|
|
Infections and infestations
Sinusitis
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Alanine Aminotransferase increased
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Aspartate Aminotransferase increase
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Creatinine increase
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
2/36 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.8%
1/36 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.8%
1/36 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Pleuritic pain
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.8%
1/36 • Number of events 1
|
Other adverse events
| Measure |
Omacetaxine and Cytarabine
n=36 participants at risk
Omacetaxine 1.25 mg/m2 subcutaneously (SQ) every 12 hours for 3 days + Cytarabine 20 mg SQ for 7 days of 4-7 week cycle.
|
|---|---|
|
Metabolism and nutrition disorders
Alanine Aminotransferase increased
|
5.6%
2/36 • Number of events 2
|
|
Metabolism and nutrition disorders
Asparatate Aminotransferase increase
|
5.6%
2/36 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
Neutropenic Fever
|
19.4%
7/36 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.9%
5/36 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
2/36 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
Sepsis
|
5.6%
2/36 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place