Lymphoma, Non-Hodgkin Clinical Trial
Official title:
A Phase II Study of Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma: Hoosier Oncology Group LYM08-134
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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