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Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT01831232
Recruitment Status : Completed
First Posted : April 15, 2013
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mazyar Shadman, Fred Hutchinson Cancer Research Center

Study Type: Interventional
Study Design: Intervention Model: Single Group 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 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)
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Refractory Anemia With Excess Blasts
Untreated Adult Acute Myeloid Leukemia
Interventions: Drug: pravastatin sodium
Drug: idarubicin
Drug: cytarabine
Other: laboratory biomarker analysis

  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 (Pravastatin Sodium, Idarubicin, and Cytarabine)

Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

pravastatin sodium: Given PO

idarubicin: Given IV

cytarabine: Given IV

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)
STARTED   24 
COMPLETED   24 
NOT COMPLETED   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
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)

Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

pravastatin sodium: Given PO

idarubicin: Given IV

cytarabine: Given IV

laboratory biomarker analysis: Correlative studies


Baseline Measures
   Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Years]
Median (Full Range)
 57 
 (35 to 72) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  62.5% 
Male      9  37.5% 
Diagnosis 
[Units: Participants]
Count of Participants
 
Acute Myeloid Leukemia (AML)   21 
Myelodysplastic Syndrome (MDS)   2 
Chronic Myelomonocytic Leukemia (CMML)   1 


  Outcome Measures

1.  Primary:   Number of Participants With Good Complete Remission (CR)   [ Time Frame: 35 days ]

2.  Primary:   Number of Participants With TRM.   [ Time Frame: 28 days ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: 1 year after treatment with IAP ]

4.  Secondary:   Overall Survival   [ Time Frame: 1 year after treatment with IAP ]

5.  Secondary:   Number of Biomarker-positive Participants With Clinical Responses   [ Time Frame: 38 days after dosing ]

6.  Secondary:   Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR)   [ Time Frame: 35 days ]


  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 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: Dr, Mazyar Shadman
Organization: Fred Hutchinson Cancer Research Ctr
phone: 206-667-5467
e-mail: mshadman@fredhutch.org



Responsible Party: Mazyar Shadman, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01831232     History of Changes
Other Study ID Numbers: 2674.00
NCI-2013-00743 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2674.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: April 8, 2013
First Posted: April 15, 2013
Results First Submitted: April 14, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017