Expired Study
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Houston, Texas 77030


Purpose of Phase II study for B-cell lymphoma using PS341: Evaluate efficacy and toxicity of bortezomib in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Study summary:

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 </= 3. - 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.



Primary Contact:

Principal Investigator
Luis Fayad, MD
UT MD Anderson Cancer Center

Backup Contact:


Location Contact:

Houston, Texas 77030
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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