Clinical trial · Interventional
Bortezomib in Treating Patients With Lymphoproliferative Disorders
Phase II Study of PS-341 in Low Grade Lymphoproliferative Disorders
NCT00023764CI-TRIAL-00020111completedPhase 2Results postedClinicalTrials.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)
Phase II trial to study the effectiveness of bortezomib in treating patients who have low-grade lymphoproliferative disorders. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Grade 1 Follicular Lymphoma | Grade 1 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Grade 2 Follicular Lymphoma | Grade 2 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Grade 3 Follicular Lymphoma | Grade 3 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive an infusion of bortezomib (dose of 1.8 mg/m2) over 3-5 seconds once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
- interventionNames
- Drug: bortezomib
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- Up to 3 years
- description
- The response probability will be estimated. The 95% confidence interval will be provided.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed lymphoproliferative disorder of 1 of the following subtypes: * \* Relapsed or refractory grade I, II, or III follicular center cell lymphoma * Relapsed or refractory mantle cell lymphoma * Measurable disease for non-Hodgkin's lymphoma (NHL) only * At least 1 unidimensionally measurable lesion * At least 2 cm by conventional techniques OR at least 1 cm by spiral CT scan * Lymph nodes no greater than 1 cm in short axis considered normal * Absolute lymphocytosis greater than 5,000/mm\^3 with B-cell phenotype (CD19, 20,or 23 positive) with more than 30% bone marrow lymphocytes for CLL or other leukemic forms of NHL * No known brain metastases * Performance status - Karnofsky 70-100% * At least 3 months * See Disease Characteristics * Absolute neutrophil count greater than 1,500/mm\^3 (500/mm\^3 if lymphomatous involvement of bone marrow) * Platelet count greater than 50,000/mm\^3 * Bilirubin less than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN (4 times ULN in case of liver metastases) * Creatinine less than 1.5 times ULN * No symptomatic congestive heart failure * No New York Heart Association class III or IV heart disease * No unstable angina pectoris * No cardiac arrhythmia * No myocardial infarction within the past 6 months * No cerebrovascular accident or transient ischemic attack within the past 6 months * No history of orthostatic hypotension * No evidence of acute ischemia or significant conduction abnormality (left anterior hemiblock in the presence of right bundle branch block or second or third degree atrioventricular blocks) on electrocardiogram * No uncontrolled hypertension requiring antihypertensive medication * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Febrile episodes up to 38.5°C allowed if no evidence of active infection * No other uncontrolled concurrent illness * No known or active HIV infection * No ongoing or active infection * No psychiatric illness or social situation that would preclude study entry * At least 3 months since prior monoclonal antibody therapy (e.g., rituximab) * No more than 3 prior regimens of conventional cytotoxic chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * At least 1 week since prior steroid therapy * At least 4 weeks since prior radiotherapy and recovered * At least 4 weeks since prior major surgery * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.