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Trial record 11 of 179 for:    LENALIDOMIDE AND Leukemia

Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic 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: NCT01465230
Recruitment Status : Terminated (This study was unsuccessful in enrolling the target number of subjects during the funding period.)
First Posted : November 4, 2011
Results First Posted : October 23, 2014
Last Update Posted : October 23, 2014
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Lymphocytic Leukemia
Intervention Drug: Maintenance lenalidomide
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide
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Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.

Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide

Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Lenalidomide
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Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.

Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
2
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
1.Primary Outcome
Title Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants withdrew from study before primary outcome could be measured
Arm/Group Title Lenalidomide
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Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.

Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide
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Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.

Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide

All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%)
Total   1/2 (50.00%) 
Vascular disorders   
Deep Vein Thrombosis * 1  1/2 (50.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC Version 4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lenalidomide
Affected / at Risk (%)
Total   1/2 (50.00%) 
Blood and lymphatic system disorders   
Decreased Platlets  1  1/2 (50.00%) 
Decreased ANC  1  1/2 (50.00%) 
Anemia  1  1/2 (50.00%) 
Decreased Calcium  1  1/2 (50.00%) 
Hypokalemia  1  1/2 (50.00%) 
Decreased Neutrophil Count  1  1/2 (50.00%) 
General disorders   
Syncope  1  1/2 (50.00%) 
Musculoskeletal and connective tissue disorders   
Sciatica Pain  1  1/2 (50.00%) 
Bilateral Hand Spasticity  1  1/2 (50.00%) 
Right Groin Pain  1  1/2 (50.00%) 
Respiratory, thoracic and mediastinal disorders   
Upper Respiratory Infection  1  1/2 (50.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC Version 4
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: Dr. Terri Parker
Organization: Yale University
Phone: 203-737-5312
EMail: terri.parker@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01465230     History of Changes
Other Study ID Numbers: 1105008515
First Submitted: October 28, 2011
First Posted: November 4, 2011
Results First Submitted: August 26, 2014
Results First Posted: October 23, 2014
Last Update Posted: October 23, 2014