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Phase 1/2 Study of VELCADE (Bortezomib), Nipent (Pentostatin), and Rituxan (Rituximab) (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma


Phase 1/Phase 2
18 Years
85 Years
Not Enrolling
Both
Follicular Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma

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Trial Information

Phase 1/2 Study of VELCADE (Bortezomib), Nipent (Pentostatin), and Rituxan (Rituximab) (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma


Number of Subjects: During the Phase 1 part of the study as many as 15 subjects may be
enrolled, based on the dose escalation scheme; the actual number of subjects enrolled will
depend on the dose level at which the maximum tolerated dose (MTD) is established.

During the Phase 2 part of the study, approximately 15 subjects will be enrolled in order to
obtain a total 30 response-evaluable subjects.

Study Objectives:

The primary objectives of this study are:

• Assess the CR and ORR following treatment with VELCADE (bortezomib), Nipent (pentostatin)
and Rituxan (rituximab) (VNR) in subjects with follicular lymphoma (FL), marginal zone
lymphoma (MZL), and mantle cell lymphoma (MCL) who have relapsed or been refractory after
receiving at least 1 prior therapy.

The secondary objectives of this study are to:

- Determine the MTD of VELCADE and Nipent in combination with Rituxan (VNR) in subjects
with follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma
(MCL) who have relapsed or been refractory after receiving at least 1 prior therapy

- Evaluate the safety and tolerability of VNR

- Determine the time to response

- Determine duration of response

- Determine the time to progression (TTP)

- Determine the progression free survival (PFS) rate

- Determine the 1-year survival

- Determine overall survival (OS)


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome Description:

Study Days 1, 4, 8, 11 of 6 cycles (up to 3 weeks each) and Days 63/126, then Study Months 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48

Outcome Time Frame:

up to 48 months

Safety Issue:

No

Principal Investigator

Francesco Turturro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

LSUHSC-S

Authority:

United States: Institutional Review Board

Study ID:

X05266

NCT ID:

NCT01460602

Start Date:

May 2010

Completion Date:

October 2014

Related Keywords:

  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Mantle Cell Lymphoma
  • Lymphoma
  • Follicular
  • Marginal Zone
  • Mantle Cell
  • Velcade
  • bortezomib
  • Nipent
  • pentastatin
  • Rituxan
  • rituximab
  • Turturro
  • Shreveport
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell

Name

Location

LSU - Shreveport Health Sciences Center, Feist-Weiller Cancer CenterShreveport, Louisiana  71103