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Brief Title: Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma
Official Title: A Phase II Study of Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma: Hoosier Oncology Group LYM08-134
Study ID: NCT01186458
Brief Summary: 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.
Detailed Description: 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Community Regional Cancer Center, Indianapolis, Indiana, United States
Arnett Cancer Care, Lafayette, Indiana, United States
Virtua Health Cancer Program, Mount Holly, New Jersey, United States
South Jersey Health Care, Vineland, New Jersey, United States
University of Rochester Medical Center, Rochester, New York, United States
Case Comprehensive Cancer Center - University Hospitals Case Medical Center, Cleveland, Ohio, United States
Seidman Cancer Center, Cleveland, Ohio, United States
Reading Hospital Regional Cancer Center, W. Reading, Pennsylvania, United States
Name: Shivani Srivastava, M.D.
Affiliation: Hoosier Cancer Research Network
Role: STUDY_CHAIR