Lenalidomide as Chemoprevention in Treating Patients With High-Risk, Early-Stage B-Cell Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Celgene Corporation
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01649791
First received: July 23, 2012
Last updated: January 14, 2014
Last verified: January 2014
Results First Received: December 26, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: B-cell Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Stage 0 Chronic Lymphocytic Leukemia
Stage I Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Interventions: Drug: lenalidomide
Other: laboratory biomarker analysis
Procedure: lymph node biopsy
Procedure: bone marrow aspiration
Other: pharmacological study
Other: flow cytometry

  Participant Flow
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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
Treatment (Lenalidomide as Chemoprevention)

Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

lenalidomide: Given orally

laboratory biomarker analysis: Correlative study

lymph node biopsy: Correlative study

bone marrow aspiration: Correlative study

pharmacological study: Correlative study

flow cytometry: Correlative study


Participant Flow:   Overall Study
    Treatment (Lenalidomide as Chemoprevention)  
STARTED     8  
COMPLETED     5  
NOT COMPLETED     3  
Disease Progression                 2  
Adverse Event                 1  



  Baseline Characteristics
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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 treated and eligible patients.

Reporting Groups
  Description
Treatment (Lenalidomide as Chemoprevention)

Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

lenalidomide: Given orally

laboratory biomarker analysis: Correlative study

lymph node biopsy: Correlative study

bone marrow aspiration: Correlative study

pharmacological study: Correlative study

flow cytometry: Correlative study


Baseline Measures
    Treatment (Lenalidomide as Chemoprevention)  
Number of Participants  
[units: participants]
  8  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 8.8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     5  
Gender  
[units: participants]
 
Female     1  
Male     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Median Progression-free Survival   [ Time Frame: 24 months ]

2.  Secondary:   Overall Response Rate (CR+PR)   [ Time Frame: 24 months ]

3.  Secondary:   Incidence of Immune Mediated Flare Reaction   [ Time Frame: 24 months ]

4.  Secondary:   Expression of B-CLL Co-stimulatory Ligands, Mic-A, and Mic-B Assessed by Flow Cytometry   [ Time Frame: 8 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
This trial did not reach full accrual.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300


No publications provided


Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01649791     History of Changes
Obsolete Identifiers: NCT01003821
Other Study ID Numbers: I 136908, NCI-2009-01327
Study First Received: July 23, 2012
Results First Received: December 26, 2013
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board