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Trial record 93 of 495 for:    LENALIDOMIDE AND every 28 days

Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01401322
Recruitment Status : Terminated (low accrual)
First Posted : July 25, 2011
Results First Posted : November 10, 2014
Last Update Posted : November 28, 2016
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Bruno C. Medeiros, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Relapsed Adult Acute Lymphocytic Leukemia
Intervention Drug: Lenalidomide
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide 50 mg/Day x 28 Days
Hide Arm/Group Description Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
Period Title: Overall Study
Started 5
Completed 3
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Physician Decision             1
Arm/Group Title Lenalidomide 50 mg/Day x 28 Days
Hide Arm/Group Description Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
Relapsed or refractory ALL (at least 1 failed prior treatment regimen)
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
39.7
(32.4 to 69.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
0
   0.0%
Male
5
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Time-to-Progression (TTP)
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide 50 mg/Day x 28 Days
Hide Arm/Group Description:

Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.

Lenalidomide: 50 mg; po

Overall Number of Participants Analyzed 3
Median (Full Range)
Unit of Measure: Days
20
(19 to 21)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide 50 mg/Day x 28 Days
Hide Arm/Group Description Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
All-Cause Mortality
Lenalidomide 50 mg/Day x 28 Days
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide 50 mg/Day x 28 Days
Affected / at Risk (%) # Events
Total   3/5 (60.00%)    
Blood and lymphatic system disorders   
Anemia * 1  1/5 (20.00%)  1
Febrile neutropenia * 1  2/5 (40.00%)  2
Blood and lymphatic system disorders-Other, Pancytopenia * 1  1/5 (20.00%)  2
General disorders   
General disorders and administration site conditions - Other, failure to thrive * 1  1/5 (20.00%)  1
Hepatobiliary disorders   
Hepatobiliary disorders - Other, abnormal liver function * 1  1/5 (20.00%)  1
Infections and infestations   
Lung infection * 1  1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide 50 mg/Day x 28 Days
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bruno C. Medeiros
Organization: Stanford University
Phone: 650-498-6000
Layout table for additonal information
Responsible Party: Bruno C. Medeiros, Stanford University
ClinicalTrials.gov Identifier: NCT01401322     History of Changes
Other Study ID Numbers: IRB-19607
SU-01142011-7364 ( Other Identifier: Stanford University )
RV_ALL_PI_0616 ( Other Identifier: Celgene Corporation )
HEMALL0006 ( Other Identifier: OnCore )
First Submitted: July 20, 2011
First Posted: July 25, 2011
Results First Submitted: October 27, 2014
Results First Posted: November 10, 2014
Last Update Posted: November 28, 2016