Clinical trial · Interventional
Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
NCT00850499CI-TRIAL-00008662terminatedPhase 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)
This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).
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 |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludarabine | Drug | Fludarabine | ALIAS |
| rituximab | Drug | Rituximab | ALIAS |
| VELCADE | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VELCADE and fludarabine (Group A)
- description
- VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
- interventionNames
- Drug: fludarabine
- Drug: VELCADE
- type
- ACTIVE_COMPARATOR
- label
- fludarabine and rituximab (Group B)
- description
- fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle
- interventionNames
- Drug: fludarabine
- Drug: rituximab
Primary outcomes (1)
- measure
- Complete Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female subjects 18 years or older * Histologically proven diagnosis of follicular non-Hodgkin's lymphoma grades 1or 2 according to the World Health Organization classification * Subjects must have received at least 12 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject's medical record * Documented relapse or progression following last antineoplastic treatment * At least 1 measurable tumor mass (≥1.5 cm x ≥1.0 cm) Exclusion Criteria: * Subjects with histological or clinical transformation to an aggressive lymphoma * prior treatment with VELCADE or fludarabine. * antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization * nitrosoureas within 6 weeks before randomization * radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization * major surgery within 3 weeks before randomization * chronic use of corticosteroids, such as dexamethasone
References
Publications (0)
Data not yet available
No reference posted for this study.