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:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
NCT ID:
NCT00636792
Eligibility Criteria:
Inclusion Criteria:
* Male or female subject 18 years of age or older
* Pathological diagnosis of follicular lymphoma (any grade)
* Documented relapse or progression following prior antineoplastic therapy
* Have received 4 or more prior doses of rituximab
* At least 1 measurable tumor mass (\>1.5 cm in the long axis and \>1.0 cm in the short axis that has not been previously irradiated, or has grown since previous irradiation
* No clinically significant central nervous system lymphoma
* Karnofsky performance status (KPS) ≥50 (equivalent to Eastern Cooperative Group Oncology Group \[ECOG\] status ≤2
Exclusion Criteria:
* Diagnosed or treated for a malignancy other than non-Hodgkin's lymphoma (NHL) within 2 years of first dose, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Subjects with prostate cancer who were treated with definitive radiotherapy and have a serum prostate-specific antigen (PSA) \<1 ng/mL are not excluded. Subjects are also not excluded if they have had basal cell or squamous cell carcinoma of the skin that was completely resected, or any in situ malignancy that was adequately treated.
* Prior treatment with VELCADE® or bendamustine
* Antineoplastic (including unconjugated therapeutic antibodies and toxin immunoconjugates), experimental, or radiation therapy within 3 weeks before Day 1 of Cycle 1
* Nitrosoureas within 6 weeks before Day 1 of Cycle 1
* Radioimmunoconjugates within 10 weeks before Day 1 of Cycle 1
* Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or prior allogeneic stem cell transplant at any time
* Major surgery within 2 weeks before Day 1 of Cycle 1
* Platelet transfusion within 7 days of Day 1 of Cycle 1 (applies to subjects enrolled in the dose escalation phase only. This does not apply to subjects enrolled in phase 2 of the study).
* Ongoing therapy with corticosteroids. Prednisone ≤15 mg per day or its equivalent is allowed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00636792
Study Brief:
Protocol Section:
NCT00636792