Trial Outcomes & Findings for Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT NCT02029417)
NCT ID: NCT02029417
Last Updated: 2016-05-09
Results Overview
Defined as recovery of morphologically normal bone marrow (\< 5% blasts) and blood counts (absolute neutrophil count \>= 1x10\^9/L, platelet counts \>= 100x10\^9/LO) and rare circulating leukemic blasts or evidence of extramedullary disease. Analyzed using exact binomial probabilities in a two-stage design. The number of responses will be tabulated.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Up to 4 years
Results posted on
2016-05-09
Participant Flow
Participant milestones
| Measure |
Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
cytarabine: Given SC
omacetaxine mepesuccinate: Given SC
decitabine: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
cytarabine: Given SC
omacetaxine mepesuccinate: Given SC
decitabine: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
n=2 Participants
INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
cytarabine: Given SC
omacetaxine mepesuccinate: Given SC
decitabine: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
75 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsPopulation: Due to the study's early termination and low accrual, data were not collected for this assessment.
Defined as recovery of morphologically normal bone marrow (\< 5% blasts) and blood counts (absolute neutrophil count \>= 1x10\^9/L, platelet counts \>= 100x10\^9/LO) and rare circulating leukemic blasts or evidence of extramedullary disease. Analyzed using exact binomial probabilities in a two-stage design. The number of responses will be tabulated.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 30 days after last dose of study drugsPopulation: All treated and eligible patients.
Maximum grade per participant of any AE.
Outcome measures
| Measure |
Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
n=2 Participants
INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
cytarabine: Given SC
omacetaxine mepesuccinate: Given SC
decitabine: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Frequency of Adverse Events, Graded According to NCI CTCAE v4.0
Grade 1
|
0 participants
|
|
Frequency of Adverse Events, Graded According to NCI CTCAE v4.0
Grade 2
|
0 participants
|
|
Frequency of Adverse Events, Graded According to NCI CTCAE v4.0
Grade 3
|
0 participants
|
|
Frequency of Adverse Events, Graded According to NCI CTCAE v4.0
Grade 4
|
2 participants
|
Adverse Events
Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
n=2 participants at risk
INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
cytarabine: Given SC
omacetaxine mepesuccinate: Given SC
decitabine: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Infections and infestations
Sepsis
|
100.0%
2/2 • Number of events 2
|
Other adverse events
| Measure |
Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
n=2 participants at risk
INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
cytarabine: Given SC
omacetaxine mepesuccinate: Given SC
decitabine: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
1/2 • Number of events 4
|
|
Cardiac disorders
Acute myocardial infarction
|
50.0%
1/2 • Number of events 1
|
|
Cardiac disorders
Atrial flutter
|
50.0%
1/2 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
50.0%
1/2 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Chest pain
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Malaise
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Multi-organ failure
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Oedema
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Pain
|
50.0%
1/2 • Number of events 1
|
|
Hepatobiliary disorders
Jaundice
|
50.0%
1/2 • Number of events 1
|
|
Infections and infestations
Candidiasis
|
50.0%
1/2 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
50.0%
1/2 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
50.0%
1/2 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
50.0%
1/2 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
50.0%
1/2 • Number of events 1
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid overload
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
50.0%
1/2 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
1/2 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
100.0%
2/2 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
100.0%
2/2 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
50.0%
1/2 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
50.0%
1/2 • Number of events 1
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis
|
50.0%
1/2 • Number of events 1
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place