NCT01186458

Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma

A Phase II Study of Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma: Hoosier Oncology Group LYM08-134

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	Fludarabine	Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
DRUG	Velcade	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.
DRUG	Rituximab	Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy.

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2010-08-23
• Last updated: 2016-10-24
• Results posted: 2016-10-24

Locations

11 sites across 1 country: United States