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Trial record 44 of 188 for:    "Acute megakaryoblastic leukemia"

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)
STARTED   2 
COMPLETED   0 
NOT COMPLETED   2 
Death                1 
Adverse Event                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated and eligible patients

Reporting Groups
  Description
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


Baseline Measures
   Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine) 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Years]
Mean (Standard Deviation)
 75  (1.8) 
Gender 
[Units: Participants]
 
Female   0 
Male   2 


  Outcome Measures

1.  Primary:   Proportion of the Evaluable Population of Interest Who Experience a Complete Response in the Poor and Good Prognosis Groups   [ Time Frame: Up to 4 years ]

2.  Primary:   Frequency of Adverse Events, Graded According to NCI CTCAE v4.0   [ Time Frame: Up to 30 days after last dose of study drugs ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to the study's early termination and low accrual no statistical inference of the primary aims were carried forth.


  More Information

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