Clinical trial · Interventional
Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma
A Phase II Study of Bortezomib in Combination With Rituximab, Fludarabine, Mitoxantrone, and Dexamethasone (VR-FND) for Relapsed or Refractory Follicular Lymphoma
NCT00510887CI-TRIAL-00014486terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effectiveness and safety of combining bortezomib (Velcade) with rituximab, fludarabine, mitoxantrone, and dexamethasone in treating patients with follicular cell 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, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VR-FND
- description
- Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum.
- interventionNames
- Drug: Bortezomib
- Drug: Rituximab
- Drug: Fludarabine
- Drug: Mitoxantrone
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Complete and Partial Response
- timeFrame
- 1 year
- description
- * Complete Response: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms and normalization of biochemical abnormalities (eg. LDH) definitely assignable to follicular lymphoma. * Partial Response requires the following: * greater than or equal to 50% decrease in the SPD of the 6 largest dominant nodes of nodal masses. * No increase in size of other nodes, liver, or spleen. * Splenic and hepatic nodes must regress by at least 50% in sum of the products (SPD). * Bone marrow assessment in irrelevant for determination of Partial Response since it is not measurable disease; however, if positive the type of cell should be reported. * No new lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of grade 1-3 follicular lymphoma with persistent, relapsed, or refractory disease to at least one prior regimen. * No prior bortezomib therapy. * Voluntary written informed consent. * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control. * Male subject agrees to use an acceptable method for contraception for the duration of the study therapy. * 18 years of age or older. * aspartate aminotransferase (AST),alanine aminotransferase (ALT), total bilirubin \< 3 times the upper limit of normal unless documented by the treating physician to be secondary to underlying lymphoma. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Exclusion Criteria: * Platelet count of \< 50,000 within 14 days before enrollment unless documented by the treating physician to be due to the disease. * Absolute neutrophil count of \< 1000 within 14 days before enrollment unless documented by the treating physician to be due to disease. * Estimated or measured creatinine clearance of less than 30 ml/min within 14 days before enrollment. * ≥Grade 2 peripheral neuropathy within 14 days before enrollment. * Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia. * Patient has hypersensitivity to boron, mannitol or any drug included in the current protocol. * Female subject is pregnant or lactating. * Received other investigational drugs for this disease within 14 days of enrollment * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Known HIV+ status. * Cardiac ejection fraction less than 35% at study entry measured by echocardiogram, Multigated Acquisition (MUGA) or cardiac MRI.
References
Publications (0)
Data not yet available
No reference posted for this study.