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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT00715208
Eligibility Criteria:
Inclusion Criteria:
* Male or female patient 18 years of age or older
* Pathological diagnosis of follicular lymphoma (any grade) or marginal zone lymphoma. Patients with transformed follicular lymphoma are eligible, provided there has previously been pathologic documentation of follicular lymphoma.
* Documented relapse or progression following prior antineoplastic therapy
* At least 1 measurable tumor mass that is greater than 1.5 cm in the long axis and greater than 1.0 cm in the short axis that has not been previously irradiated, or has grown since previous irradiation
* No clinically significant evidence of active 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. Patients with prostate cancer who were treated with definitive radiotherapy who have a serum prostate-specific antigen \<1 ng/mL are not excluded. Patients are 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.
* Received any of the following treatments or procedures outside of the specified timeframes:
* Prior treatment with VELCADE
* Prior treatment with a cumulative dose of doxorubicin of more than 100 mg/m2, if assigned to Arm A (VELCADE-R-CAP)
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00715208
Study Brief:
Protocol Section:
NCT00715208