Clinical trial · Interventional
Bortezomib in Treating Patients With Diffuse Large B-Cell Lymphoma That Is Refractory To Chemotherapy
A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
NCT00066508CI-TRIAL-00008819completedPhase 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)
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have diffuse large B-cell lymphoma that is refractory to previous chemotherapy.
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 | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall response rate (combined complete response and partial response)
Secondary outcomes (4)
- measure
- Safety
- measure
- Tolerability
- measure
- Time to disease progression
- measure
- Possible mechanism of resistance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed diffuse large B-cell lymphoma, meeting criteria for 1 of the following: * Relapsed after prior high-dose chemotherapy with stem cell support * Relapsed after prior chemotherapy, including at least 1 prior standard non-Hodgkin's chemotherapy regimen, but not a candidate for high-dose chemotherapy with stem cell support * Measurable disease * At least 1 bidimensionally measurable lesion at least 1.5 cm by CT scan * No primary or secondary CNS lymphoma * No HIV-related lymphoma * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * Hemoglobin at least 9 g/dL * Absolute neutrophil count at least 1,000/mm\^3 * No colony-stimulating factors within 4 weeks before obtaining this result * Platelet count at least 50,000/mm\^3 * No platelet transfusion within 4 weeks before obtaining this result Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN * No active hepatitis B or C viral infection Renal * Creatinine no greater than 2 times ULN OR * Creatinine clearance at least 60 mL/min Cardiovascular * No myocardial infarction within the past 6 months * No evidence of acute ischemia or new conduction system abnormalities on EKG * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Sodium greater than 130 mEq/L * HIV negative * No ongoing or active infection * No other concurrent uncontrolled illness that would preclude study participation * No psychiatric illness or social situation that would preclude study compliance * No prior allergic reaction attributable to compounds of similar chemical or biological composition to bortezomib PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * See Chemotherapy * At least 4 weeks since prior immunotherapy Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy * More than 12 weeks since prior high-dose chemotherapy with hematopoietic stem cell support Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * More than 4 weeks since prior major surgery unless fully recovered Other * Recovered from prior therapy * No other concurrent investigational agents * No other concurrent investigational or commercial agents or therapies to treat the malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.