Status and phase
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About
The goal of this multi-center Phase II study is to add bortezomib to the highly active regimen of bendamustine and rituximab. In this study, bortezomib will be administered on a weekly schedule (Days 1, 8, 15) and will be added to bendamustine/rituximab given in 4-week cycles. This combination uses the standard bendamustine dosing schedule, and is more convenient than the 5-week regimen of these 3 drugs currently being studied.
Enrollment
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Volunteers
Inclusion criteria
Histologically-confirmed indolent lymphoma by the World Health Organization (WHO) classification. The biopsy must fulfill one of the following criteria:
At least one of the following criteria must be met:
The lymph node biopsy or other lymphoma pathology specimen has CD20+ B-cells.
Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease.
No previous systemic treatment for lymphoma. Patients may have had a single course of radiation therapy to a limited field (i.e., not exceeding two adjacent lymph node regions).
The patient has bidimensionally measurable disease with at least 1 lesion measuring ≥2.0 cm in a single dimension, and the field was not previously radiated.
An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
Adequate hematologic function ≤7 days prior to start of study treatment:
Calculated or measured creatinine clearance ≥30 mL/min ≤7 days of study enrollment (using Cockcroft-Gault method).
Adequate hepatic function (≤2.5 x upper limit of normal [ULN] for alanine aminotransferase [ALT], aspartate aminotransferase [AST], and alkaline phosphatase and total bilirubin within normal limits).
Patients must be ≥18 years of age.
Women of childbearing potential must agree to use a medically acceptable method of birth control (e.g., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 12 months after their last dose of rituximab. Men must use an acceptable method/form of contraception for the duration of treatment and for 3 months after the end of treatment.
Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
55 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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