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Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00634244
Recruitment Status : Completed
First Posted : March 12, 2008
Results First Posted : July 7, 2015
Last Update Posted : July 7, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: 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 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)
Recurrent Adult Acute Myeloid Leukemia
Interventions: Drug: alvocidib
Drug: mitoxantrone hydrochloride
Drug: carboplatin
Drug: cytarabine
Drug: sirolimus
Drug: etoposide
Drug: topotecan hydrochloride

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was activated on October 16, 2008 and closed on August 2, 2013 with a total of 92 patients accrued. Duration the response evaluation after meeting the first stage accrual goal, Arm C did not meet the criteria to continue onto the second stage and was closed to accrual at that time.

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
Arm A (Carboplatin and Topotecan Hydrochloride)

Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.

carboplatin: Given IV

topotecan hydrochloride: Given IV

Arm B (Alvocidib, Mitoxantrone Hydrochloride, Cytarabine)

Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.

alvocidib: Given IV

mitoxantrone hydrochloride: Given IV

cytarabine: Given IV

Arm C (Mitoxantrone Hydrochloride, Cytarabine, Sirolimus)

Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)

mitoxantrone hydrochloride: Given IV

cytarabine: Given IV

sirolimus: Given PO

etoposide: Given IV


Participant Flow:   Overall Study
    Arm A (Carboplatin and Topotecan Hydrochloride)   Arm B (Alvocidib, Mitoxantrone Hydrochloride, Cytarabine)   Arm C (Mitoxantrone Hydrochloride, Cytarabine, Sirolimus)
STARTED   35   37   20 
Eligible and Treated   35   36   20 
COMPLETED   34   24   20 
NOT COMPLETED   1   13   0 
Never started treatment                0                1                0 
Death                1                6                0 
Adverse Event                0                2                0 
Withdrawal by Subject                0                1                0 
Physician Decision                0                1                0 
Disease progression/relapse                0                1                0 
Other complicating disease                0                1                0 



  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.
Eligible and treated patients

Reporting Groups
  Description
Arm A (Carboplatin+Topotecan Hydrochloride) Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
Arm B (Alvocidib+Cytarabine+Mitoxantrone) Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine) Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
Total Total of all reporting groups

Baseline Measures
   Arm A (Carboplatin+Topotecan Hydrochloride)   Arm B (Alvocidib+Cytarabine+Mitoxantrone)   Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   36   20   91 
Age 
[Units: Years]
Median (Full Range)
 55 
 (23 to 67) 
 62 
 (19 to 69) 
 52 
 (22 to 68) 
 57 
 (19 to 69) 
Gender 
[Units: Participants]
       
Female   14   14   9   37 
Male   21   22   11   54 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   1   1   2   4 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   1   4   2   7 
White   33   30   14   77 
More than one race   0   0   1   1 
Unknown or Not Reported   0   1   1   2 
Disease status 
[Units: Participants]
       
< 6 months after 1st CR   9   11   6   26 
6-12 mos after 1st CR   8   8   3   19 
Refractory   18   17   10   45 
Unknown/Missing   0   0   1   1 


  Outcome Measures

1.  Primary:   The Rate of Complete Remission (CR+CRi)   [ Time Frame: Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration. ]

2.  Secondary:   The Rate of Treatment Failure   [ Time Frame: Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration. ]


  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: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00634244     History of Changes
Other Study ID Numbers: NCI-2009-00520
NCI-2009-00520 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E1906 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: March 11, 2008
First Posted: March 12, 2008
Results First Submitted: June 10, 2015
Results First Posted: July 7, 2015
Last Update Posted: July 7, 2015