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

Phase II Study of Proteasome Inhibitor PS-341 For Patients With Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00038571

Enrollment

Registered

2002-06-03

Start date

2002-05-31

Completion date

2005-03-31

Last updated

2018-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, B-Cell

Keywords

Cancer, Relapsed, Refractory, B cell lymphoma, Proteasome Inhibitor, PS-341

Brief summary

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.

Detailed description

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.

Interventions

DRUGPS341 (Bortezomib)

1.5 mg/m2 intravenous (IV) bolus push over 3 to 5 seconds on days 1, 4, 8, and 11, followed by a 10-day rest for a 21-day cycle.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Patients with Response to PS-341	Every two 21-day cycles	Patient response evaluated according to criteria of Cheson et al. Endoscopy obtained every two cycles to evaluate response using Complete Response (CR), Partial Response (PR), Progressive Disease, or Stable Disease.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026