Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01253070
First received: December 2, 2010
Last updated: January 13, 2016
Last verified: December 2015
Results First Received: January 13, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Myeloid Leukemia (Megakaryoblastic) With t(1;22)(p13;q13); RBM15-MKL1
Acute Myeloid Leukemia With a Variant RARA Translocation
Acute Myeloid Leukemia With Inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN1-EVI1
Acute Myeloid Leukemia With t(6;9)(p23;q34); DEK-NUP214
Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
Acute Myeloid Leukemia With Variant MLL Translocations
Untreated Adult Acute Myeloid Leukemia
Interventions: Drug: Daunorubicin Hydrochloride
Drug: Sorafenib Tosylate
Drug: Cytarabine
Procedure: Bone Marrow Aspiration
Procedure: Biopsy
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 54 participants were recruited from April 2011 to August 2013.

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 (Daunorubicin, Cytarabine, Sorafenib Tosylate)

INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.

CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.


Participant Flow:   Overall Study
    Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)  
STARTED     54  
COMPLETED     54  
NOT COMPLETED     0  



  Baseline Characteristics
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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 (Daunorubicin, Cytarabine, Sorafenib Tosylate)

INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.

CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.


Baseline Measures
    Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)  
Number of Participants  
[units: participants]
  54  
Age  
[units: years]
Median (Full Range)
  67.4   (60.3 to 82.7)  
Gender  
[units: participants]
 
Female     24  
Male     30  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     47  
Unknown or Not Reported     5  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     51  
More than one race     0  
Unknown or Not Reported     2  
Region of Enrollment  
[units: participants]
 
United States     54  
FLT3 Mutation [1]
[units: participants]
 
ITD     39  
TKD     15  
[1] FLT3 (FMS-like tyrosine kinase-3) mutation testing at baseline was performed centrally for all patients. Participants were eligible for the study if they had an ITD (internal tandem duplication) or TKD (tyrosine kinase domain) mutation.



  Outcome Measures
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1.  Primary:   Overall Survival (OS) Rate   [ Time Frame: 1 year ]

2.  Secondary:   OS   [ Time Frame: Time from registration to death (up to 10 years) ]

3.  Secondary:   Event-free Survival   [ Time Frame: Time from registration to death or relapse (up to 10 years) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Geoffrey Uy, MD
Organization: Washington University School of Medicine
e-mail: guy@dom.wustl.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01253070     History of Changes
Other Study ID Numbers: NCI-2011-02618
NCI-2011-02618 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000689593
CALGB 11001 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-11001 ( Other Identifier: CTEP )
U10CA180821 ( US NIH Grant/Contract Award Number )
U10CA031946 ( US NIH Grant/Contract Award Number )
Study First Received: December 2, 2010
Results First Received: January 13, 2016
Last Updated: January 13, 2016
Health Authority: United States: Food and Drug Administration