Clinical trial · Interventional
Velcade, Nipent, Rituxan (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma
Phase 1/2 Study of VELCADE (Bortezomib), Nipent (Pentostatin), and Rituxan (Rituximab) (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma
NCT01460602CI-TRIAL-00046875withdrawnPhase 1 / Phase 2ClinicalTrials.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): Investigator has relocated to MD Anderson
Summary
Brief summary (as posted)
This is a phase 1/2 Study of VELCADE (bortezomib), Nipent (pentostatin), and Rituxan (rituximab) (VNR) in Subjects with Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma.
Conditions
Conditions (3)
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 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MTD of Velcade, Nipent and Rituxan established in Part 1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1: establish MTD
- description
- Part 1 consists of dosing to determine maximum tolerated dose (MTD) and dose limiting toxicity (DLT).
- interventionNames
- Drug: MTD of Velcade, Nipent and Rituxan established in Part 1
- type
- EXPERIMENTAL
- label
- Part 2: The MTD from Part 1
- description
- During the Phase 2 part of the study, approximately 24 additional subjects will be enrolled in order to obtain a total of 30 response-evaluable subjects treated at the maximum tolerated dose.
- interventionNames
- Drug: MTD of Velcade, Nipent and Rituxan established in Part 1
Primary outcomes (2)
- measure
- CR following treatment with VELCADE(bortezomib)/Nipent(pentostatin/Rituxan (rituximab)(VNR) in subjects with follicular lymphoma(FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)relapsed or refractory after at least 1 prior therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntary written informed consent. 2. Male or female subject 18 years of age and older 3. Karnofsky Performance Status (KPS) score of 50%. ECOG Performance Status score greater than 2. 4. Histologically confirmed follicular Grade 1-3a, marginal zone or mantle cell NHL. 5. Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment. 6. Bi-dimensionally measurable disease with at least 1 lesion 2 cm in a single dimension 7. Hematologic, hepatic, and renal function parameters. 8. Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs 9. Expected survival of 3 months 10. Accepted birth control methods during treatment and for 12 months after completion of treatment. Exclusion Criteria: 1. Follicular lymphoma Grade 3b 2. History of allergy to any of the study medications, their analogues, murine proteins, or excipients in the various formulations 3. Grade 2 peripheral neuropathy or clinical examination within 14 days before enrollment 4. Serum creatinine 2.5 mg/dL within 14 days before enrollment. 5. Absolute neutrophil count (ANC) \< 1,000/L, platelet count \< 70,000/L within 14 days before enrollment 6. Aspartate transaminase (AST \[SGOT\]) and alanine transaminase (ALT/SGPT\]) \> 2 x the upper limit of normal (ULN), total bilirubin \> 3 ULN 7. Rituxan refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior Rituxan or prior Rituxan-containing regimen, or a response with a TTP of less than 6 months) 8. Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosurea or mytomycin-C) 9. Prior lymphoma vaccine therapy within 12 months to Study Day 1 10. Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1 11. Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1 12. Known history of hepatitis or hepatic disease. 13. Presence of central nervous system (CNS) lymphoma 14. Known history of HIV infection or AIDS 15. Histologic transformation (Follicular or Marginal zone to diffuse large B cell lymphoma \[DLBCL\] 16. Presence of pleural or peritoneal effusion with positive cytology for lymphoma 17. Another primary malignancy requiring active treatment 18. Serious non-malignant disease (e.g., congestive heart failure \[CHF\], hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions (including psychiatric), which would compromise protocol objectives n the opinion of the Investigator and/or Sponsor 19. New York Heart Association Class III or IV (Appendix D) cardiac disease 20. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1 21. Female subject who is pregnant or currently breast-feeding 22. Received other investigational drugs with 14 days before enrollment 23. Hypersensitivity to bortezomib, pentostatin, rituximab, boron or mannitol.
References
Publications (0)
Data not yet available
No reference posted for this study.