Combination of Lenalidomide and Obinutuzumab (GA101) in Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive obinutuzumab by
vein over about 3-4 hours on Days 1, 2, 8, and 15 of Cycle 1, and then on Day 1 of Cycles
2-6.

Starting on Day 9 of Cycle 1, you will take lenalidomide capsules by mouth 1 time each day.
You should swallow your dose of lenalidomide whole with a glass (about 8 ounces) of water, at
about the same time each day. Do not break, chew, or open the capsules. If you miss a dose of
lenalidomide, take it as soon as you remember on the same day only. Do not make up any doses
of lenalidomide on the next day.

If the doctor thinks it is needed, you may have to take lenalidomide more or less often and
the dose you are taking may change. Your doctor will discuss this with you.

Study Visits:

Each study cycle is 28 days.

Each week during Cycle 1 and during the first week of Cycle 2, blood (about 2 teaspoons) will
be drawn for routine tests. After Cycle 2, this blood draw will happen every 14 or 28 days,
depending on what the doctor thinks is needed.

If you are able to become pregnant, at the beginning of each week of Cycle 1, blood (about 1
teaspoon) or urine will be collected for a pregnancy test. After Cycle 1, you will have this
pregnancy test every 14 or 28 days, depending on what the doctor thinks is needed.

On Day 1 (+/-10 days) of Cycles 2-6:

- You will have a physical exam.

- Blood (about 2 teaspoons) will be drawn to check the status of the disease and to check
your immune system.

After Cycle 3, 6, 12, and every 6 cycles after that (Cycles 18, 24, 30, and so on), (+/-14
days from Day 1 of subsequent cycle):

- You will have a physical exam

- Blood (about 2 teaspoons) will be drawn to check the status of the disease and to check
your immune system.

- You will have a bone marrow biopsy/aspiration to check the status of the disease, to
check your immune system, for cytogenic testing, biomarker testing (including genetic
biomarkers), and flow cytometry testing.

At any time during the study, if the doctor thinks it is needed, you will have radiographic
testing to check the status of the disease.

Length of Treatment:

You may continue taking lenalidomide for as long as the doctor thinks it is in your best
interest. You may receive up to 6 cycles of obinutuzumab. You will no longer be able to take
the study drugs if the disease gets worse, if intolerable side effects occur, or if you are
unable to follow study directions.

Inclusion Criteria:

1. Age 18 years or older at the time of signing informed consent. Able to understand and
to provide voluntarily informed consent;

2. Have documented CLL/SLL according to NCI criteria;

3. Recurrent or refractory disease according to NCI criteria;

4. Patient are eligible if they have received one or more prior treatment;

5. ECOG performance status of 0-2 (Appendix 1);

6. Life expectancy > 6 months;

7. Adequate renal function indicated by serum creatinine less or equal to 2 mg/dl;

8. Adequate hepatic function indicated as total bilirubin less or equal to 2 mg/dl and
ALT/GPT less or equal to two times the upper normal limit;

9. Disease free of prior malignancies for 3 years with exception of currently treated
basal cell squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
or breast. Patients with malignancies with indolent behavior such as prostate cancer
treated with radiation or surgery can be enrolled in the study as long as they have a
reasonable expectation to have been cured with the treatment modality received

10. No prior history of myelodysplastic syndrome or other myeloid malignancy;

11. All participants must be registered into the mandatory Revlimid REMS® program, and be
willing and able to comply with the requirements of the Revlimid REMS ®;

12. Females of childbearing potential (FCBP) must have a negative serum and/or urine
pregnancy test with a sensitive of at least 50 mIU/mL within 10-14 days and again
within 24 hours prior to prescribe lenalidomide for cycle 1 (prescriptions must be
filled within 7 days as required by Revlimid REMS®) 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.

Exclusion Criteria:

1. Known sensitivity to lenalidomide or other thalidomide derivatives or anti CD20;

2. Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood);

3. Known history of infection with Human immunodeficiency virus (HIV) or Human T Cell
Leukemia Virus 1 (HTLV-1);

4. Serologic status reflecting active hepatitis B or C. Patients with hepatitis B (HBV)
antibody positive but who have positivity for Hepatitis B surface antigen (HBsAg) or
anti Hepatitis B core antibody (anti-HBc) and patients who are positive for anti-HCV
will need to have a negative PCR (viral HBV DNA or HCV RNA) result prior to
enrollment. Those who are HBsAg positive or HBV DNA positive and those who are
positive for HCV (RNA) will be excluded;

5. Pregnant or breast feeding females;

6. History of tuberculosis treated within the last five years or recent exposure to
tuberculosis;

7. Any serious medical condition, laboratory abnormality, or psychiatric illness that
places the subject unacceptable risk if he/she were to participate to the study;

8. Patients with a recent history of deep vein thrombosis or pulmonary embolus, in the
six months prior to enrollment are not eligible for this study.