Clinical trial · Interventional
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
NCT00038571CI-TRIAL-00035549completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PS341 (Bortezomib) | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (mantle-cell lymphoma)
- interventionNames
- Drug: PS341 (Bortezomib)
- type
- EXPERIMENTAL
- label
- Arm B (other B-cell lymphomas)
- interventionNames
- Drug: PS341 (Bortezomib)
Primary outcomes (1)
- measure
- Number of Patients with Response to PS-341
- timeFrame
- Every two 21-day cycles
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTGoy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F, Fayad L, Dang NH, Samaniego F, Wang M, Broglio K, Samuels B, Gilles F, Sarris AH, Hart S, Trehu E, Schenkein D, Cabanillas F, Rodriguez AM. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005 Feb 1;23(4):667-75. doi: 10.1200/JCO.2005.03.108. Epub 2004 Dec 21. PMID 15613697