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Cyclosporine, Pravastatin Sodium, Etoposide, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01342887
Recruitment Status : Terminated
First Posted : April 27, 2011
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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)
Recurrent Adult Acute Myeloid Leukemia
Interventions: Drug: cyclosporine
Drug: pravastatin sodium
Drug: mitoxantrone hydrochloride
Drug: etoposide
Procedure: bone marrow aspiration

  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 (Immunosuppression, Enzyme Inhibitor, and Chemo)

Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.

cyclosporine: Given IV

pravastatin sodium: Given PO

mitoxantrone hydrochloride: Given IV

etoposide: Given IV

bone marrow aspiration: Correlative studies


Participant Flow:   Overall Study
    Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)
STARTED   6 
COMPLETED   4 
NOT COMPLETED   2 
Death                2 



  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 (Immunosuppression, Enzyme Inhibitor, and Chemo)

Patients receive cyclosporine IV continuously on days 5-9. Patients also receive pravastatin sodium PO every 6 hours on days 1-10, etoposide IV continuously on days 5-9, and mitoxantrone hydrochloride IV continuously on days 5-9. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/CRi may receive 2 additional courses in the absence of disease progression or unacceptable toxicity.

cyclosporine: Given IV

pravastatin sodium: Given PO

mitoxantrone hydrochloride: Given IV

etoposide: Given IV

bone marrow aspiration: Correlative studies


Baseline Measures
   Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo) 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Years]
Mean (Full Range)
 51 
 (40 to 57) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  66.7% 
Male      2  33.3% 


  Outcome Measures

1.  Primary:   Maximum Tolerated Doses Mitoxantrone Hydrochloride and Etoposide When Combined With Cyclosporine and Pravastatin Sodium   [ Time Frame: After completion of first 2 courses, up to 22 weeks ]

2.  Secondary:   CR/CRi   [ Time Frame: After completion of first 2 courses, up to 22 weeks ]

3.  Secondary:   Disease-free Survival of Patients That Achieve CR/CRi   [ Time Frame: Up to 4.5 years ]

4.  Secondary:   Frequency and Severity of Regimen-associated Toxicities   [ Time Frame: At 28 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Roland B. Walter, MD, PhD, MS
Organization: Fred Hutch Cancer Research Center
e-mail: rwalter@fredhutch.org



Responsible Party: Roland Walter, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01342887     History of Changes
Other Study ID Numbers: 2409.00
NCI-2011-00657 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: April 22, 2011
First Posted: April 27, 2011
Results First Submitted: April 5, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017