Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT01186458|
Recruitment Status : Terminated (Slow accrual)
First Posted : August 23, 2010
Results First Posted : October 24, 2016
Last Update Posted : October 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin||Drug: Fludarabine Drug: Velcade Drug: Rituximab||Phase 2|
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
- 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).
- Total bilirubin ≤1.5 ULN
- Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN
- Creatinine < 1.5 x institutional upper limit (ULN) or creatinine clearance ≥ 50 cc/min
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma: Hoosier Oncology Group LYM08-134|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Fludarabine, Velcade and Rituximab
Fludarabine, Velcade and Rituximab
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.
- Overall Response Rate [ Time Frame: 6 months ]To determine the overall response rate and frequency of complete and partial responses in patients with relapsed or refractory follicular non-Hodgkin lymphoma (NHL) who receive therapy with fludarabine, Velcade, and rituximab administered every 28 days.
- Survival [ Time Frame: 6 months ]To evaluate the progression-free survival and event-free survival in patients who receive therapy with fludarabine, Velcade, and rituximab.
- Toxicity [ Time Frame: 6 months ]To evaluate the toxicity profile of this regimen. Adverse event counts by grade are presented.
- Biologic Interaction [ Time Frame: 6 months ]To explore the biologic interaction between fludarabine and Velcade and determine if Velcade can potentiate the DNA-damaging effect of fludarabine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186458
|United States, Indiana|
|Cancer Care Center of Southern Indiana|
|Bloomington, Indiana, United States, 47403|
|Fort Wayne Oncology & Hematology, Inc|
|Fort Wayne, Indiana, United States, 46815|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Community Regional Cancer Center|
|Indianapolis, Indiana, United States, 46256|
|Arnett Cancer Care|
|Lafayette, Indiana, United States, 47904|
|United States, New Jersey|
|Virtua Health Cancer Program|
|Mount Holly, New Jersey, United States, 08060|
|South Jersey Health Care|
|Vineland, New Jersey, United States, 08360|
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, Ohio|
|Case Comprehensive Cancer Center - University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Seidman Cancer Center|
|Cleveland, Ohio, United States, 44106|
|United States, Pennsylvania|
|Reading Hospital Regional Cancer Center|
|W. Reading, Pennsylvania, United States, 19611|
|Study Chair:||Shivani Srivastava, M.D.||Hoosier Cancer Research Network|