Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT01186458
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
Study:
NCT01186458
Study Brief:
Protocol Section:
NCT01186458