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Spots Global Cancer Trial Database for Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma

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Trial Identification

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

Study Description

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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Shivani Srivastava, M.D.

Affiliation: Hoosier Cancer Research Network

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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