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Chlorambucil + Lenalidomide and Lenalidomide Maintenance in Untreated Elderly With Chronic Lymphocytic Leukemia (CLL)

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: NCT01403246
Recruitment Status : Terminated (Slow patient enrollment and new molecules for chronic lymphoid leukemia, have importantly reduced the interest of conducting the phase II of this study.)
First Posted : July 27, 2011
Results First Posted : January 23, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Chronic Lymphocytic Leukemia
Intervention Drug: Lenalidomide; Chlorambucil
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide and Chlorambucil
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title Study Group
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
72
(67 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
3
  33.3%
Male
6
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 9 participants
9
1.Primary Outcome
Title Number of Dose Limiting Toxic Events (DLT) of Lenalidomide Given in Combination With Chlorambucil.
Hide Description [Not Specified]
Time Frame At maximum 8 months from induction therapy start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Toxic events
0
Time Frame 3 years and 3 months
Adverse Event Reporting Description The adverse events in the present study report have been classified according to the CTCAE grading. These are included under the Serious Adverse Events, although the fields in the form do not allow to specify grading.
 
Arm/Group Title Study Group
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Study Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Study Group
Affected / at Risk (%) # Events
Total   6/9 (66.67%)    
Blood and lymphatic system disorders   
Neutropenia †  2/9 (22.22%)  5
Anemia †  1/9 (11.11%)  2
Thrombocytopenia †  3/9 (33.33%)  6
†
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Group
Affected / at Risk (%) # Events
Total   0/9 (0.00%)    
[Not Specified]
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.
PIs of participating centres may disclose their centre's results only after the main study publication has been released, so that a single centre experience can be compared to the study overall results and give a more appropriate view of the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alfonso Piciocchi
Organization: GIMEMA
Phone: +393203671224
EMail: a.piciocchi@gimema.it
Layout table for additonal information
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01403246     History of Changes
Other Study ID Numbers: CLL0709
First Submitted: January 13, 2011
First Posted: July 27, 2011
Results First Submitted: February 23, 2016
Results First Posted: January 23, 2019
Last Update Posted: February 12, 2019