Proteasome Inhibitor PS-341 Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy

Patients were stratified, based on preclinical data, into arm A (mantle-cell lymphoma) or arm
B (other B-cell lymphomas) without limitation in number of prior therapies. Bortezomib was
administered as an intravenous push (1.5 mg/m2) on days 1, 4, 8, and 11 every 21 days for a
maximum of six cycles.

INCLUSION:

- Relapsed or Refractory B cell lymphoma.

- Zubrod status
- Measurable disease.

- No anti-cancer treatment within past 3 weeks.

- ANC >= 1500/uL, Plt >/= 50,000, Bilirubin <2 mg/dL, SGPT <2.5xULN, creatinine <2.
Patients with ANC>/1000, PLT>/30000 will be eligible if due to massive splenomegaly
and/or BM involvement.

- HIV negative.

- No active CNS lymphoma.

- No serious intercurrent illness, active infections or cancer except basal cell
carcinoma of the skin or in situ cervical carcinoma.

- Not eligible for treatment of a higher priority. Patients may be entered before BMT.

- No pregnancy & age bearing females must be practicing adequate contraception.

- Age > 16.

EXCLUSION:

- Patients with platelets <30x10(9)/L within 14 days before enrollment.

- Patients with ANC<1.0 x10(9)/L within 14 days before enrollment.

- Patients with peripheral neuropathy >/= grade 3 within 14 days before enrollment.