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Entinostat And Imatinib Mesylate In Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT01383447
Recruitment Status : Terminated (This study was halted prematurely by the NCI for low accrual.)
First Posted : June 28, 2011
Results First Posted : August 8, 2017
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
Recurrent Adult Acute Lymphoblastic Leukemia
Interventions: Drug: entinostat
Drug: imatinib mesylate
Other: laboratory biomarker analysis
Other: pharmacological study
Genetic: western blotting
Other: immunohistochemistry staining method
Other: flow cytometry
Genetic: polymerase chain reaction
Other: high performance liquid chromatography
Other: mass spectrometry

  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 (Entinostat and Imatinib Mesylate)

Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

entinostat: Given PO

imatinib mesylate: Given PO

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

western blotting: Correlative studies

immunohistochemistry staining method: Correlative studies

flow cytometry: Correlative studies

polymerase chain reaction: Correlative studies

high performance liquid chromatography: Correlative studies

mass spectrometry: Correlative studies


Participant Flow:   Overall Study
    Treatment (Entinostat and Imatinib Mesylate)
STARTED   2 
COMPLETED   0 
NOT COMPLETED   2 



  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.
No text entered.

Reporting Groups
  Description
Treatment (Entinostat and Imatinib Mesylate)

Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

entinostat: Given PO

imatinib mesylate: Given PO

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

western blotting: Correlative studies

immunohistochemistry staining method: Correlative studies

flow cytometry: Correlative studies

polymerase chain reaction: Correlative studies

high performance liquid chromatography: Correlative studies

mass spectrometry: Correlative studies


Baseline Measures
   Treatment (Entinostat and Imatinib Mesylate) 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      1  50.0% 
>=65 years      1  50.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  50.0% 
Male      1  50.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      2 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   2 


  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) of Entinostat When Given in Combination With Imatinib Mesylate   [ Time Frame: Up to 30 days post-treatment ]

2.  Secondary:   Rate of Complete Response (CR) for Adults With Relapsed/Refractory Ph+ ALL Treated With a Combination of Entinostat (at the Dose Determined in Phase 1) and Imatinib Mesylate   [ Time Frame: Up to 30 days post-treatment ]

3.  Secondary:   Progression Free Survival (PFS) for Adults With Relapsed/Refractory Ph+ ALL Treated With Combination of Entinostat and Imatinib Mesylate   [ Time Frame: At 1 year ]

4.  Secondary:   Comparative Pharmacokinetics (PK) and Pharmacodynamics (PD) of Entinostat Alone vs. Entinostat Plus Imatinib Mesylate   [ Time Frame: Day 4 and 11 ]

5.  Secondary:   Predictive Values of Levels of Flow Cytometric Minimal Residual Disease (MRD) on Duration of Progression Free Survival for the Study Population   [ Time Frame: Day 29 ]


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Patrick Brown
Organization: Johns Hopkins Sidney Kimmel Cancer Center
phone: 410-614-4915
e-mail: pbrown2@jhmi.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01383447     History of Changes
Other Study ID Numbers: NCI-2010-02202
J1023
U01CA070095 ( U.S. NIH Grant/Contract )
First Submitted: May 5, 2011
First Posted: June 28, 2011
Results First Submitted: April 14, 2017
Results First Posted: August 8, 2017
Last Update Posted: August 8, 2017