Status:
COMPLETED
Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Lead Sponsor:
Celgene
Conditions:
Relapsed or Refractory Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
Eligibility Criteria
Inclusion
- Age ≥ 18 years at the time of signing the informed consent form
- Must be able to adhere to the study visit schedule and other protocol requirements
- Must have a documented diagnosis of B-cell CLL
- Must be relapsed or refractory to at least 1 regimen for treatment of CLL. At least one of the prior treatments must have included a purine analog-based or bendamustine-based regimen
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.
Exclusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- Active infections requiring systemic antibiotics
- Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide treatment
- Alemtuzumab therapy within 120 days of initiating lenalidomide treatment
- Prior therapy with lenalidomide
- History of grade 4 rash due to prior thalidomide treatment
- Planned autologous or allogeneic bone marrow transplantation
- Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
- Uncontrolled hyperthyroidism or hypothyroidism
- Venous thromboembolism within 12 months
- ≥ Grade 2 neuropathy
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Disease transformation \[i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia\]
- Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy
Key Trial Info
Start Date :
October 19 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2017
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00963105
Start Date
October 19 2009
End Date
September 5 2017
Last Update
October 31 2018
Active Locations (52)
Enter a location and click search to find clinical trials sorted by distance.
1
UCSD Moores Cancer Center
La Jolla, California, United States, 92093-0820
2
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States, 92270
3
Stanford University School of Medicine
Stanford, California, United States, 94305-5821
4
Cancer Center of Central Connecticut
Southington, Connecticut, United States, 06489