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Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT02029417
Recruitment Status : Terminated (Major revisions needed in study)
First Posted : January 7, 2014
Results First Posted : May 9, 2016
Last Update Posted : May 9, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Teva Pharmaceutical Industries, Ltd.
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Interventions Drug: cytarabine
Drug: omacetaxine mepesuccinate
Drug: decitabine
Other: laboratory biomarker analysis
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Death             1
Adverse Event             1
Arm/Group Title Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
Hide Arm/Group Description

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 Number of Baseline Participants 2
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants
75  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
1.Primary Outcome
Title Proportion of the Evaluable Population of Interest Who Experience a Complete Response in the Poor and Good Prognosis Groups
Hide Description 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.
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study's early termination and low accrual, data were not collected for this assessment.
Arm/Group Title Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Frequency of Adverse Events, Graded According to NCI CTCAE v4.0
Hide Description Maximum grade per participant of any AE.
Time Frame Up to 30 days after last dose of study drugs
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients.
Arm/Group Title Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
Hide Arm/Group Description:

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 Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
Grade 1 0
Grade 2 0
Grade 3 0
Grade 4 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Infections and infestations   
Sepsis   2/2 (100.00%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Blood and lymphatic system disorders   
Febrile neutropenia   1/2 (50.00%)  4
Cardiac disorders   
Acute myocardial infarction   1/2 (50.00%)  1
Atrial flutter   1/2 (50.00%)  1
Myocardial infarction   1/2 (50.00%)  1
Tachycardia   1/2 (50.00%)  1
Gastrointestinal disorders   
Abdominal pain   1/2 (50.00%)  1
Constipation   1/2 (50.00%)  1
Diarrhoea   1/2 (50.00%)  1
Nausea   1/2 (50.00%)  1
Retroperitoneal haematoma   1/2 (50.00%)  1
General disorders   
Chest pain   1/2 (50.00%)  1
Malaise   1/2 (50.00%)  1
Multi-organ failure   1/2 (50.00%)  1
Oedema   1/2 (50.00%)  1
Pain   1/2 (50.00%)  1
Hepatobiliary disorders   
Jaundice   1/2 (50.00%)  1
Infections and infestations   
Candidiasis   1/2 (50.00%)  1
Cellulitis   1/2 (50.00%)  1
Injury, poisoning and procedural complications   
Fall   1/2 (50.00%)  1
Investigations   
Blood bilirubin increased   1/2 (50.00%)  1
Blood creatinine increased   1/2 (50.00%)  1
Platelet count decreased   1/2 (50.00%)  2
Metabolism and nutrition disorders   
Decreased appetite   1/2 (50.00%)  1
Fluid overload   1/2 (50.00%)  1
Hypoalbuminaemia   1/2 (50.00%)  1
Tumour lysis syndrome   1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders   
Back pain   1/2 (50.00%)  1
Muscular weakness   1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough   1/2 (50.00%)  1
Dyspnoea   1/2 (50.00%)  3
Pleural effusion   1/2 (50.00%)  1
Respiratory distress   1/2 (50.00%)  1
Respiratory failure   2/2 (100.00%)  2
Tachypnoea   2/2 (100.00%)  2
Wheezing   1/2 (50.00%)  1
Vascular disorders   
Deep vein thrombosis   1/2 (50.00%)  1
Hypotension   1/2 (50.00%)  1
Thrombophlebitis   1/2 (50.00%)  1
Indicates events were collected by systematic assessment
Due to the study's early termination and low accrual no statistical inference of the primary aims were carried forth.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT02029417     History of Changes
Other Study ID Numbers: I 245213
NCI-2013-02425 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 245213 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Submitted: January 6, 2014
First Posted: January 7, 2014
Results First Submitted: March 1, 2016
Results First Posted: May 9, 2016
Last Update Posted: May 9, 2016