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Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01349972
First Posted: May 9, 2011
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: September 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
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: alvocidib
Drug: daunorubicin hydrochloride
Drug: mitoxantrone hydrochloride
Drug: cytarabine

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)

Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.

alvocidib: Given IV

mitoxantrone hydrochloride: Given IV

cytarabine: Given IV

Arm II (Cytarabine, Daunorubicin Hydrochloride)

Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.

daunorubicin hydrochloride: Given IV

cytarabine: Given IV


Participant Flow:   Overall Study
    Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)   Arm II (Cytarabine, Daunorubicin Hydrochloride)
STARTED   114   58 
COMPLETED   109   56 
NOT COMPLETED   5   2 



  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.
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Reporting Groups
  Description
Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)

Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.

alvocidib: Given IV

mitoxantrone hydrochloride: Given IV

cytarabine: Given IV

Arm II (Cytarabine, Daunorubicin Hydrochloride)

Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.

daunorubicin hydrochloride: Given IV

cytarabine: Given IV

Total Total of all reporting groups

Baseline Measures
   Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)   Arm II (Cytarabine, Daunorubicin Hydrochloride)   Total 
Overall Participants Analyzed 
[Units: Participants]
 114   58   172 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      79  69.3%      43  74.1%      122  70.9% 
>=65 years      35  30.7%      15  25.9%      50  29.1% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      53  46.5%      27  46.6%      80  46.5% 
Male      61  53.5%      31  53.4%      92  53.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Response Rate   [ Time Frame: 3 years ]

2.  Secondary:   Incidence of Toxicities, Characterized by Number of Events by Treatment and Grade   [ Time Frame: Up to 14 days after completion of study treatment ]

3.  Secondary:   Disease-free Survival   [ Time Frame: Time from randomization until death from any cause or relapse or recurrence, assessed up to 2 years ]

4.  Secondary:   Overall Survival   [ Time Frame: 4 years ]

5.  Secondary:   Number of Patients With Minimal Residual Disease   [ Time Frame: From study start to 14 days after the start of treatment ]

6.  Secondary:   Progression-free Survival   [ Time Frame: 4 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
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  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: Joshua Zeidner
Organization: University of North Carolina, Lineberger Comprehensive Cancer Center
phone: (919) 962-5164
e-mail: Joshua_Zeidner@med.unc.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01349972     History of Changes
Obsolete Identifiers: NCT01413880
Other Study ID Numbers: NCI-2011-02587
NCI-2011-02587 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
JHOC-J1101
CDR0000699421
J1101 ( Other Identifier: Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center )
8972 ( Other Identifier: CTEP )
U01CA070095 ( U.S. NIH Grant/Contract )
N01CM00100 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
First Submitted: May 6, 2011
First Posted: May 9, 2011
Results First Submitted: September 4, 2015
Results First Posted: June 6, 2017
Last Update Posted: July 31, 2017