Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter's Syndrome

This is a phase I trial to determine the safety and tolerability of the combination of
obinutuzumab, lenalidomide, and HDMP for patients with RS. There is not a standard of care
for patients with Richter's Syndrome (RS). Ten patients will be enrolled with RS diagnosed by
histology or flow cytometry and CLL, regardless of prior treatment for either condition.

Inclusion Criteria:

- Histologic diagnosis of Richter's Syndrome (RS)

- No requirement nor restriction for prior therapy or stage

- Measurable disease: may include FDG avid lesion, lymph node greater than 1.5 cm in
greatest diameter, or clonal large B-cells in peripheral blood or bone marrow.

- ECOG 0-2

- Adequate organ function

- Adequate bone marrow function

Lenalidomide-related inclusion criteria:

- Able to take aspirin (81mg or 325mg) daily, warfarin, low molecular weight heparin, or
equivalent anticoagulation as prophylactic medication.

- All study participants must be registered into the mandatory REVLIMID REMS® program,
and be willing and able to comply with the requirements of REMS®.

- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
test within 10 - 14 days prior to and again within 24 hours prior to starting
REVLIMID® 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 REVLIMID®. FCBP must also agree to ongoing pregnancy testing.

- Males must agree to use a latex condom during sexual contact with a FCBP even if they
have had a successful vasectomy.

Exclusion Criteria:

- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy

- Known hypersensitivity to any of the study drugs

- Patients with a malignancy that has been treated, but not with curative intent, will
be excluded, unless the malignancy has been in remission without treatment for 2 years
prior to enrollment.

- Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding
fungal infections of nail beds) or any major episode of infection requiring treatment
with IV antibiotics or hospitalization (related to the completion of the course of
antibiotics) within 4 weeks before the start of treatment

- Major surgery within 4 weeks prior to the start of treatment

- Known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus
1 (HTLV-1) seropositive status

- Positive hepatitis serology

- Women who are pregnant or lactating

- Vaccination with a live vaccine a minimum of 28 days prior to the start of treatment

- Uncontrolled diabetes mellitus

- Myocardial infarction within 6 months of starting study drug

- Other clinically significant heart disease