The purpose of this study is to determine the effectiveness of fludarabine, Velcade, and rituximab treatment regimen in patients with relapsed or refractory follicular non-Hodgkin lymphoma.
OUTLINE: This is a multi-center study. * Fludarabine 25 mg/m2 IV over 30 minutes , Days 1, 2, 4 * Velcade(given after fludarabine) 1.3 mg/m2 IV push over 3 to 5 seconds, Days 1, 4, 8, 11 * Rituximab (given after Velcade) 375 mg/m2 IV piggyback, Day 1 * Cycle = 28 days; max 6 cycles ECOG Performance Status: 0-2 Life Expectancy: Not specified Hematopoietic: * Absolute neutrophil count (ANC) ≥ 1.5 K/mm3 (ANC \> 0.5 K/mm3 if known lymphomatous involvement of the bone marrow). * Platelets ≥ 100 K/mm3 (Platelets \>50 K/mm3 if known lymphomatous involvement of the bone marrow). Hepatic: * Total bilirubin ≤1.5 ULN * Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN * Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN Renal: * Creatinine \< 1.5 x institutional upper limit (ULN) or creatinine clearance ≥ 50 cc/min Cardiovascular: * No myocardial infarction within 6 months prior to enrollment * No heart failure per New York Heart Association Classification III or IV * No severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy.
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Overall Response Rate
To determine the overall response rate and frequency of complete and partial responses in patients with relapsed or refractory follicular non-Hodgkin lymphoma (NHL) who receive therapy with fludarabine, Velcade, and rituximab administered every 28 days.
Time frame: 6 months
Survival
To evaluate the progression-free survival and event-free survival in patients who receive therapy with fludarabine, Velcade, and rituximab.
Time frame: 6 months
Toxicity
To evaluate the toxicity profile of this regimen. Adverse event counts by grade are presented.
Time frame: 6 months
Biologic Interaction
To explore the biologic interaction between fludarabine and Velcade and determine if Velcade can potentiate the DNA-damaging effect of fludarabine.
Time frame: 6 months
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