AEG35156-204: A Phase 1-2, Multicenter, Open-Label Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia and Indolent B-Cell Lymphomas

Inclusion Criteria:

- Patients with an histologically confirmed diagnosis of CLL as per NCI-WG criteria or

- Patients with an histologically confirmed diagnosis of one of the following indolent
B-cell lymphomas: (Follicular lymphoma (FL); Small lymphocytic lymphoma (SLL);
Marginal zone lymphoma; Lymphoplasmacytic lymphoma)

- Relapsed or refractory patients who have failed at least 2 prior lines of therapy,
one of which may have been high dose therapy and autologous stem cell
transplantation. Steroids alone when used for autoimmune phenomena do not qualify as
prior therapy

- ECOG performance less or equal than 2

- Life expectancy of at least 3 months

- Age greater or equal than 18 years

- Signed, written IRB-approved informed consent

- A negative serum pregnancy test (if applicable)

- Acceptable liver function:(Bilirubin within normal limit; AST (SGOT) and ALT (SGPT)
less or equal than 2.5 x ULN or less or equal than 5 x ULN if there are liver
lymphomatous involvement)

- Acceptable renal function: (Serum creatinine within normal limits, OR calculated
creatinine clearance greater or equal than 60 mL/min/1.73 m2 for patients with
creatinine levels above institutional normal)

- Acceptable hematologic status: (Granulocyte greater or equal than 1000 cells/uL;
Platelet count greater or equal than 50,000 /uL)

- Acceptable coagulation status:(PT within normal limits; PTT within normal limits)

- For women of child-producing potential, the use of effective contraceptive methods
during the study

- Prior radiotherapy for local disease is allowed provided disease progression has been
documented, and treatment completed at least 4 weeks prior to registration

Exclusion Criteria:

- Uncontrolled autoimmune hemolysis and/or thrombocytopenia

- Richter's transformation

- Histologic transformation

- Patients with peripheral neuropathy

- Active progressive leptomeningeal disease including the presence of any related
symptoms or need for corticosteroids. A CT or MRI scan of the head is necessary in
patients with a history of leptomeningeal disease to document the stability of prior
lesions

- Pregnant or nursing women. NOTE: Women of child-bearing potential must agree to use
adequate contraception (sterile or surgically sterile; hormonal or barrier method of
birth control; or abstinence) prior to study entry and for the duration of study
participation. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately

- Men who are unwilling to use acceptable forms of birth control when engaging in
sexual contact with women of child bearing potential

- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
therapy

- Known infection with HIV, hepatitis B, or hepatitis C

- Serious nonmalignant disease that could compromise protocol objectives in the opinion
of the investigator and/or the sponsor

- Patients who are currently receiving any other investigational agent. Subjects who
have used a previous antisense oligonucleotide in the last 90 days will be excluded

- Unwillingness or inability to comply with procedures required in this protocol