Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT01460602
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01460602
Study Brief:
Protocol Section:
NCT01460602