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Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00352365
Recruitment Status : Completed
First Posted : July 14, 2006
Results First Posted : July 4, 2013
Last Update Posted : July 31, 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)
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Intervention: Drug: lenalidomide

  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
Lenalidomide Induction Therapy: Oral lenalidomide once daily on days 1-14, 1-21, or 1-28. Maintenance Therapy: Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)

Participant Flow for 2 periods

Period 1:   Induction Therapy
    Lenalidomide
STARTED   41 
Eligible   38 
Eligible and Began Protocol Therapy   37 
COMPLETED   14 
NOT COMPLETED   27 
Adverse Event                7 
Progression/Relapse                8 
Death                7 
Not protocol specified                1 
Not eligible                3 
Death before starting protocol therapy                1 

Period 2:   Maintenance Therapy
    Lenalidomide
STARTED   12 
Eligible and Began Protocol Therapy   8 
COMPLETED   0 
NOT COMPLETED   12 
Progression/Relapse                3 
Death                2 
Not protocol specified                3 
Not eligible                4 



  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.
Eligible patients who began protocol therapy

Reporting Groups
  Description
Induction Therapy Oral lenalidomide once daily on days 1-14, 1-21, or 1-28

Baseline Measures
   Induction Therapy 
Overall Participants Analyzed 
[Units: Participants]
 37 
Age 
[Units: Years]
Median (Full Range)
 73.7 
 (60.1 to 94) 
Gender 
[Units: Participants]
 
Female   21 
Male   16 
Race/Ethnicity, Customized 
[Units: Participants]
 
Black or African American   3 
White   33 
Unknown or Not Reported   1 
Hispanic 
[Units: Participants]
 
Yes   1 
No   32 
Unknown   4 
Disease Onset 
[Units: Participants]
 
De Novo   16 
Treatment related   2 
MDS related   19 
Performance Status [1] 
[Units: Participants]
 
 7 
 30 
[1] Performance status is graded according to the Zubrod Performance Status Scale. Patients with a performance status of 0 are fully active, able to carry on all pre-disease performance without restriction. Patients with a performance status of 1 are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.


  Outcome Measures

1.  Primary:   Complete Response   [ Time Frame: Up to 5 years ]

2.  Secondary:   Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Up to 5 years ]

3.  Secondary:   Cytogenetic Abnormalities   [ Time Frame: Up to 5 years ]

4.  Secondary:   Total Response   [ Time Frame: 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: SWOG
phone: 206-667-4623


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00352365     History of Changes
Other Study ID Numbers: NCI-2009-00785
NCI-2009-00785 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-S0605
CDR0000484449
S0605 ( Other Identifier: Southwest Oncology Group )
S0605 ( Other Identifier: CTEP )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: July 13, 2006
First Posted: July 14, 2006
Results First Submitted: May 15, 2013
Results First Posted: July 4, 2013
Last Update Posted: July 31, 2014