An Open-Label Phase 2 Study of Lenalidomide (Revlimid) in Combination With Oral Dexamethasone in the Treatment of Previously Untreated, Symptomatic Patients With Chronic Lymphocytic Leukemia (CLL)
1. Understand and voluntarily sign an informed consent form.
2. Age >/=18 years at the time of signing the informed consent form.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. A confirmed diagnosis of B-cell CLL by IWCLL 2008 criteria
5. No prior systemic therapy for CLL. Steroid therapy alone for autoimmune cytopenias
(anemia or thrombocytopenia) is NOT considered a prior systemic therapy.
Radiation: Patients may have received prior radiation therapy restricted to = 25%
of functioning bone marrow. Patients must be >/= 4 weeks since last treatment with
Surgery: previous surgery is permissible. Patient must be >/= 4 weeks since any major
6. Patients must have symptomatic disease requiring therapy as per the IWCLL 2008
criteria. One or more of the following must be present to be eligible:
- Massive (>10cm diameter), progressive or symptomatic lymphadenopathy
- Massive (>6 cm below costal margin) or progressive or symptomatic splenomegaly
- Anemia (Hb <110 g/L)
- Thrombocytopenia (platelets <100 x 109/L)
- Constitutional symptoms (one of the following):
- Weight loss >10% or more over previous 6 months
- Significant fatigue
- Fevers >38 degrees Celsius for 2 or more weeks without infection
- Night sweats > 1 month without evidence of infection
- Other constitutional symptoms felt to require treatment as per treating
- Persistent rise in lymphocyte count with doubling time of < 6 months
- Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids
or other standard therapy
7. ECOG performance status of = 2 at study entry
8. Laboratory Requirements: (must be done within 7 days prior to first study drug dose)
Hematology: Absolute granulocytes (AGC)>/= 1000/mm³ Platelets >/= 50,000/mm³
Chemistry: Creatinine clearance>/= 30ml/min (by Cockcroft-Gault calculation, see
Appendix 9) Bilirubin = 1.5 x UNL AST (or ALT if AST not available) = 2.5 x UNL
9. Females of childbearing potential (FCBP)† must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to
and again within 24 hours of starting lenalidomide and must either commit to
continued abstinence from heterosexual intercourse or begin TWO acceptable methods of
birth control, one highly effective method and one additional effective method AT THE
SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also
agree to ongoing pregnancy testing. Men must agree to use a latex condom during
sexual contact with a FCBP even if they have had a successful vasectomy. All
patients must be counseled at a minimum of every 28 days about pregnancy precautions
and risks of fetal exposure.
10. Disease free of prior malignancies for >/= 5 years with exception of currently
treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the
cervix or breast
11. Able to take aspirin 81 mg daily as prophylactic anticoagulation (patients intolerant
to ASA may use warfarin or low molecular weight heparin).
Patients who fulfill any of the following criteria are not eligible for admission to the
1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.
2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed
while taking lenalidomide).
3. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.
4. Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome.
Subjects may be enrolled upon correction of electrolyte abnormalities.
5. Use of any other experimental drug or therapy within 28 days of baseline.
6. Known hypersensitivity to thalidomide.
7. The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.
8. Any prior use of lenalidomide.
9. Concurrent use of other anti-cancer agents or treatments.
10. Known positive for HIV or infectious hepatitis, type B or C.
11. Known intolerance to steroids (i.e. poorly controllable hyperglycemia or
hypertension, significant mood disturbances, steroid-related myopathy, etc.)