Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL
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|ClinicalTrials.gov Identifier: NCT00772668|
Recruitment Status : Terminated (Funding)
First Posted : October 15, 2008
Results First Posted : February 21, 2013
Last Update Posted : December 11, 2017
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving rituximab together with cyclophosphamide, bortezomib, and prednisone may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving rituximab together with cyclophosphamide, bortezomib, and prednisone works as first-line therapy in treating patients with stage III or stage IV follicular lymphoma or marginal zone lymphoma.
|Condition or disease||Intervention/treatment|
|Lymphoma Follicular Lymphoma Marginal Zone Lymphoma||Drug: Rituximab Drug: Bortezomib Drug: Cyclophosphamide Drug: Prednisone|
- Induction therapy: Patients receive rituximab IV and cyclophosphamide IV over 30 minutes on day 1, bortezomib IV on days 1 and 8, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance therapy.
- Maintenance therapy: Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL)|
|Actual Study Start Date :||September 25, 2009|
|Primary Completion Date :||December 2010|
|Study Completion Date :||February 2011|
Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):
Administered intravenously during induction and maintenance therapy per protocol.
Other Name: RituxanDrug: Bortezomib
Administered intravenously per protocol.
Other Name: VelcadeDrug: Cyclophosphamide
Administered intravenously per protocol.
Other Name: CytoxanDrug: Prednisone
Administered orally (PO) per protocol.
Other Name: Deltasone
- Overall Response Rate, According to the International Workshop Criteria (IWC) for Non-Hodgkin's Lymphoma (NHL) [ Time Frame: Post cycles 2,4,6,8 and then every 3 months, about 2 years ]
Rate of overall response (CR, CRu, PR) to protocol therapy according to International Workshop Criteria (IWC):
- Complete Response (CR) includes complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL;
- Complete Response Unconfirmed (CRu) includes above CR criteria but a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the product of the perpendicular diameters (SPD), or indeterminate bone marrow;
- Partial Response (PR) includes >= 50% decrease in SPD of the six largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen.
- Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]Progression free-survival will be assessed according to according to the International Workshop Criteria (IWC). Progression-free survival will be measured as the time from date of enrollment to relapse, progression or death due to follicular lymphoma (FL) or marginal zone lymphoma (MZL), whichever occurs first. Participants who do not experience relapse or progression, and those who die from causes other than cancer, will be censored at the date of last contact.
- Overall Survival (OS) [ Time Frame: Up to 5 years ]Overall survival (OS) will be measured as the time from date of enrollment to death from any cause. For patients who remain alive, survival time will be censored at the date of last contact.
- Rate of Toxicity in Study Participants [ Time Frame: Up to 5 years ]Safety and tolerance to protocol therapy as evidenced by the rate of toxicity (serious adverse events and study-related adverse events) in study participants
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): NCT00772668
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Denise Pereira, MD||University of Miami Sylvester Comprehensive Cancer Center|