A Phase II Study of Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma: Hoosier Oncology Group LYM08-134
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
6 months
No
Shivani Srivastava, M.D.
Study Chair
Hoosier Oncology Group
United States: Institutional Review Board
HOG LYM08-134
NCT01186458
October 2010
July 2012
Name | Location |
---|---|
University of Rochester Medical Center | Rochester, New York 14642 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Arnett Cancer Care | Lafayette, Indiana 47904 |
Cancer Care Center Of Southern Indiana | Bloomington, Indiana 47403 |
Reading Hospital Regional Cancer Center | West Reading, Pennsylvania 19612 |
Community Regional Cancer Center | Indianapolis, Indiana 46256 |
Fort Wayne Oncology & Hematology, Inc | Fort Wayne, Indiana 46815 |
Virtua Health Cancer Program | Mount Holly, New Jersey 08060 |
South Jersey Health Care | Vineland, New Jersey 08360 |
Seidman Cancer Center | Cleveland, Ohio 44106 |
Case Comprehensive Cancer Center - University Hospitals Case Medical Center | Cleveland, Ohio 44106 |