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
Drug: MTD of Velcade, Nipent and Rituxan established in Part 1
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Locations near you
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Full eligibility criteria for NCT01460602
Ages eligible for Study
18 Years to 85 Years
Genders eligible for Study
Accepts Healthy Volunteers
Voluntary written informed consent.
Male or female subject 18 years of age and older
Karnofsky Performance Status (KPS) score of 50%. ECOG Performance Status score greater than 2.
Histologically confirmed follicular Grade 1-3a, marginal zone or mantle cell NHL.
Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment.
Bi-dimensionally measurable disease with at least 1 lesion 2 cm in a single dimension
Hematologic, hepatic, and renal function parameters.
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
Expected survival of 3 months
Accepted birth control methods during treatment and for 12 months after completion of treatment.
Follicular lymphoma Grade 3b
History of allergy to any of the study medications, their analogues, murine proteins, or excipients in the various formulations
Grade 2 peripheral neuropathy or clinical examination within 14 days before enrollment
Serum creatinine 2.5 mg/dL within 14 days before enrollment.
Absolute neutrophil count (ANC) < 1,000/L, platelet count < 70,000/L within 14 days before enrollment
Aspartate transaminase (AST [SGOT]) and alanine transaminase (ALT/SGPT]) > 2 x the upper limit of normal (ULN), total bilirubin > 3 ULN
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)
Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosurea or mytomycin-C)
Prior lymphoma vaccine therapy within 12 months to Study Day 1
Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1
Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1
Known history of hepatitis or hepatic disease.
Presence of central nervous system (CNS) lymphoma
Known history of HIV infection or AIDS
Histologic transformation (Follicular or Marginal zone to diffuse large B cell lymphoma [DLBCL]
Presence of pleural or peritoneal effusion with positive cytology for lymphoma
Another primary malignancy requiring active treatment
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
New York Heart Association Class III or IV (Appendix D) cardiac disease
Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1
Female subject who is pregnant or currently breast-feeding
Received other investigational drugs with 14 days before enrollment
Hypersensitivity to bortezomib, pentostatin, rituximab, boron or mannitol.
All locations for NCT01460602
United States (1)
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71103
View full eligibility
Tris trial is registered with FDA with number: NCT01460602. The sponsor of the trial is Louisiana State University Health Sciences Center Shreveport and it is looking for 0 volunteers for the current phase.
Official trial title: Phase 1/2 Study of VELCADE (Bortezomib), Nipent (Pentostatin), and Rituxan (Rituximab) (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma
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