Conditions: Lymphoma, Non-Hodgkin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

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

Arms:
arm 1: Fludarabine, Velcade and Rituximab

Interventions: intervention 1: Fludarabine intervention 2: Velcade intervention 3: Rituximab
Intervention descriptions: intervention 1: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy. intervention 2: 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. intervention 3: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy.

Protocol document: