Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT01186458
Status:
TERMINATED
Last Update Posted:
2016-10-24
First Post:
2010-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma
Sponsor:
Hoosier Cancer Research Network
Organization:
Study Overview
Official Title:
A Phase II Study of Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma: Hoosier Oncology Group LYM08-134
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: