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Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00096122
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : July 15, 2011
Last Update Posted : May 26, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
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)
Childhood Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Refractory Anemia With Excess Blasts
Refractory Anemia With Excess Blasts in Transformation
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Untreated Adult Acute Myeloid Leukemia
Interventions: Drug: cytarabine
Drug: idarubicin
Drug: tipifarnib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 9/16/2004 to 9/22/2006. All patients registered at The University of Texas M.D. Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant enrolled was excluded from the study.

Reporting Groups
  Description
Idarubicin, Cytarabine + Tipifarnib Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.

Participant Flow:   Overall Study
    Idarubicin, Cytarabine + Tipifarnib
STARTED   95 
COMPLETED   95 
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
Idarubicin, Cytarabine + Tipifarnib Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.

Baseline Measures
   Idarubicin, Cytarabine + Tipifarnib 
Overall Participants Analyzed 
[Units: Participants]
 95 
Age 
[Units: Years]
Median (Full Range)
 50 
 (17 to 61) 
Gender 
[Units: Participants]
 
Female   53 
Male   42 
Region of Enrollment 
[Units: Participants]
 
United States   95 


  Outcome Measures

1.  Primary:   Number of Participants With Complete Response   [ Time Frame: 21 Day Cycle ]


  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: Jorge Cortes, MD / Professor
Organization: UT MD Anderson Cancer Center
phone: 713-745-5783
e-mail: eharrison@mdanderson.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096122     History of Changes
Other Study ID Numbers: NCI-2012-02862
2003-0563
6625
N01CM62202 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2004
First Posted: November 9, 2004
Results First Submitted: June 13, 2011
Results First Posted: July 15, 2011
Last Update Posted: May 26, 2014