Lenalidomide in Combination With Plerixafor in Patients With Previously Treated Chronic Lymphocytic Leukemia
- Histologically confirmed diagnosis of CLL or SLL as established by the NCI Working
Group Response Criteria (NCI 96 Criteria).
- Received one or more prior therapies for CLL.
- Patients must have symptomatic disease requiring therapy as defined by the protocol.
- >/= 4 weeks from prior cancer therapy.
- ECOG performance status of = 2.
- All study participants must be registered into the mandatory RevAssist® program, and
be willing and able to comply with the requirements of RevAssist®.
- Prolymphocytic leukemia (PLL).
- Richter's (large cell) transformation.
- Prior allogeneic transplant within 12 months or prior allogeneic transplant > 12
months currently receiving immunosuppressants.
- Active autoimmune hemolytic anemia.
- CNS involvement.
- Chronic enteral corticosteroids > 10mg prednisone or equivalent.
- Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome
- Use of any other experimental drug or therapy within 28 days of baseline
- Major surgery within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.
- Any prior use of lenalidomide.
- Known seropositive for or active viral infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).