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Trial record 35 of 188 for:    "Acute megakaryoblastic leukemia"

Decitabine Followed by Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory AML and MDS

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ClinicalTrials.gov Identifier: NCT01607645
Recruitment Status : Terminated (The study was terminated early because there were other competing protocols.)
First Posted : May 30, 2012
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Derek Stirewalt, Fred Hutchinson Cancer Research Center

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 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)
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Myeloid Leukemia
Refractory Anemia With Excess Blasts
Interventions: Drug: decitabine
Drug: idarubicin
Drug: cytarabine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participant were enrolled between 8/23/12 and 5/16/13 at the FHCRC

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 I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV


Participant Flow:   Overall Study
    Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)   Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)
STARTED   4   3 
COMPLETED   4   3 
NOT COMPLETED   0   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.
No text entered.

Reporting Groups
  Description
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)

Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)

Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

decitabine: Given IV

idarubicin: Given IV

cytarabine: Given IV

Total Total of all reporting groups

Baseline Measures
   Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)   Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   3   7 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.75  (16.46)   34.67  (13.01)   43.86  (16.31) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  50.0%      2  66.7%      4  57.1% 
Male      2  50.0%      1  33.3%      3  42.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      4 100.0%      3 100.0%      7 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1  33.3%      1  14.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      4 100.0%      2  66.7%      6  85.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   4   3   7 


  Outcome Measures

1.  Primary:   Number of Participants Who Achieved Morphologic CR   [ Time Frame: Participants were monitored up until the point when they went off study following completion of the treatment (3 months) ]

2.  Secondary:   Resistant Disease Defined as Patient Survives at Least 14 Days After Completion of the Last Dose of Induction or Re-induction But Has Persistent Leukemia in Peripheral Blood (PB) or BM   [ Time Frame: Assessed for up to 90 days ]

3.  Secondary:   Cytogenetic Response Defined as no Detectable Cytogenetic Abnormality in a Subsequent BM Specimen After Induction or Re-induction   [ Time Frame: Assessed for up to 5 years ]

4.  Secondary:   CRMRD- Defined as Morphologic CR Without Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers   [ Time Frame: Assessed for up to 5 years ]

5.  Secondary:   CRi Defined as Meeting All Criteria for a Morphologic CR But ANC Remains Less Than 1,000/μL and/or Platelet Count Less Than 100,000/μL   [ Time Frame: Assessed for up to 5 years ]

6.  Secondary:   CRMRD+ Defined as a Morphologic CR But With Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers   [ Time Frame: Assessed for up to 5 years ]

7.  Secondary:   CRiMRD+ Defined as Meeting All Criteria for a CRi But With Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers   [ Time Frame: Assessed for up to 5 years ]

8.  Secondary:   TRM With Each Course of Decitabine-priming, Idarubicin, and Cytarabine   [ Time Frame: Assessed for up to Day 30 ]

9.  Secondary:   Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0   [ Time Frame: Assessed for up to 3 months after completion study treatment ]

10.  Secondary:   Severe Prolonged Aplasia   [ Time Frame: Assessed for up to 45 days ]

11.  Secondary:   Duration of Severe Neutropenia Defined as an ANC Less Than 500   [ Time Frame: Assessed for up to 5 years ]

12.  Secondary:   Duration of Moderate Neutropenia Defined as an ANC Less Than 1000   [ Time Frame: Assessed for up to 5 years ]

13.  Secondary:   Duration of Thrombocytopenia Defined as Platelet Count Less Than 100,000   [ Time Frame: Assessed for up to 5 years ]


  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
Early termination due to similar competing protocol, which made statistical evaluation of primary endpoint and any meaningful evaluation of secondary time points not feasible.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Derek L. Stirewalt
Organization: FHCRC
phone: 2066675386
e-mail: dstirewa@fhcrc.org



Responsible Party: Derek Stirewalt, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01607645     History of Changes
Other Study ID Numbers: 2588.00
NCI-2012-00769 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2012
First Posted: May 30, 2012
Results First Submitted: October 13, 2016
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017