Status:
COMPLETED
Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Celgene Corporation
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is for patients with chronic lymphocytic leukemia (CLL) who have not yet received any treatment for their disease. Current therapy for this disease includes the use of combination chemothe...
Detailed Description
This is a single institution Phase II study where all enrolled patients with untreated CLL will receive fludarabine and rituximab (FR) combination therapy. Subjects who demonstrate Stable disease or P...
Eligibility Criteria
Inclusion
- Understand and voluntarily sign informed consent form
- No prior therapy for CLL
- Able to adhere to study visit schedule and other protocol requirements
- CLL with any Rai Stage requiring therapy
- ECOG performance status \</= 2
- Absolute neutrophil count \>/= 1.0
- Platelet count \>/= 75
- Serum creatinine \</= 1.5
- Total bilirubin \</= 1.5
- AST and ALT \</= 2 x ULN
- Females of childbearing potential must have negative pregnancy test
- Disease free of prior malignancies for \>/= 5 years
- Able to take aspirin daily as prophylactic anticoagulation
Exclusion
- Any serious medical condition, lab abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- Pregnant or lactating females
- Any condition, including the presence of lab abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Use of any other experimental drug or therapy within 28 days of baseline
- Concurrent use of other anti-cancer agents or treatments
- Known positive for HIV or infectious active hepatitis, type A, B
- Known hypersensitivity to nucleoside analogue or rituximab
- Previous treatment for CLL prior to enrolling in study
- Known hypersensitivity to thalidomide
- The development of erythema nodosum if characterized by desquamating rash while taking thalidomide or similar drugs
- Any prior use of lenalidomide
- Active hemolysis
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00860457
Start Date
February 1 2008
End Date
February 1 2012
Last Update
November 21 2018
Active Locations (1)
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1
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007