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Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

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ClinicalTrials.gov Identifier: NCT00093470
Recruitment Status : Completed
First Posted : October 8, 2004
Results First Posted : November 10, 2015
Last Update Posted : April 19, 2018
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: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Adult Acute Megakaryoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With Minimal Differentiation
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A
Adult Acute Myeloid Leukemia Without Maturation
Adult Acute Myelomonocytic Leukemia
Adult Erythroleukemia
Adult Pure Erythroid Leukemia
Alkylating Agent-Related Acute Myeloid Leukemia
Myelodysplastic Syndrome With Excess Blasts
Recurrent Adult Acute Myeloid Leukemia
Interventions: Procedure: Clinical Observation
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
This study was activated on August 18, 2004, suspended between August 8, 2007 and February 6, 2008 for toxicity and safety evaluation, and closed on December 7, 2009 with a total of 144 patients accrued.

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 (Tipifarnib)

Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Tipifarnib: Given PO

Arm B (Clinical Observation)

Patients undergo observation only.

Clinical Observation: Undergo observation


Participant Flow:   Overall Study
    Arm A (Tipifarnib)   Arm B (Clinical Observation)
STARTED   73   71 
Treated   72   71 
Patients With Toxicity Assessment   72   69 
COMPLETED   0 [1]   71 [2] 
NOT COMPLETED   73   0 
Disease progression                39                0 
Adverse Event                15                0 
Death                2                0 
Withdrawal by Subject                8                0 
Alternative therapy                2                0 
Other complicating disease                3                0 
Physician Decision                2                0 
Never started treatment                1                0 
ANC < 1000 on day 1 of cycle 1                1                0 
[1] Treatment continued until disease progression or unacceptable toxicities.
[2] Patients underwent observation only.



  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.
All randomized patients

Reporting Groups
  Description
Arm A (Tipifarnib)

Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Tipifarnib: Given PO

Arm B (Clinical Observation)

Patients undergo observation only.

Clinical Observation: Undergo observation

Total Total of all reporting groups

Baseline Measures
   Arm A (Tipifarnib)   Arm B (Clinical Observation)   Total 
Overall Participants Analyzed 
[Units: Participants]
 73   71   144 
Age 
[Units: Years]
Median (Full Range)
 70 
 (30 to 86) 
 69 
 (28 to 80) 
 69 
 (28 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      37  50.7%      34  47.9%      71  49.3% 
Male      36  49.3%      37  52.1%      73  50.7% 


  Outcome Measures

1.  Primary:   Disease-free Survival   [ Time Frame: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years. ]

2.  Secondary:   Overall Survival   [ Time Frame: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, 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
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-ACRIN Statistical Office
phone: 617-632-6012



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00093470     History of Changes
Other Study ID Numbers: NCI-2009-00535
NCI-2009-00535 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E2902
E2902 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
E2902 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: October 6, 2004
First Posted: October 8, 2004
Results First Submitted: October 13, 2015
Results First Posted: November 10, 2015
Last Update Posted: April 19, 2018