Study Stopped
Funding
Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL
Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL)
2 other identifiers
interventional
3
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lymphoma
Started Sep 2009
Shorter than P25 for not_applicable lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2008
CompletedFirst Posted
Study publicly available on registry
October 15, 2008
CompletedStudy Start
First participant enrolled
September 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
February 21, 2013
CompletedDecember 11, 2017
November 1, 2017
1.2 years
October 12, 2008
January 18, 2013
November 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate, According to the International Workshop Criteria (IWC) for Non-Hodgkin's Lymphoma (NHL)
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.
Post cycles 2,4,6,8 and then every 3 months, about 2 years
Secondary Outcomes (3)
Progression-free Survival (PFS)
Up to 5 years
Overall Survival (OS)
Up to 5 years
Rate of Toxicity in Study Participants
Up to 5 years
Study Arms (1)
RCVELP
EXPERIMENTALRituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP): * Rituximab * Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles * Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles * Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles * Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles * Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Interventions
Administered intravenously during induction and maintenance therapy per protocol.
Eligibility Criteria
You may qualify if:
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Histologically confirmed, untreated follicular lymphoma (FL) grade I, II or marginal zone lymphoma (MZL) Stage III or IV
- Presence of measurable or evaluable disease
- Age \>17 years old
- Patients must have normal organ and marrow function as defined below, within 14 days of enrollment:
- Serum bilirubin \< 2.0 mg/dL
- serum creatinine \< 2 mg/dL unless due to lymphoma
- Absolute Neutrophil Count (ANC) \>1000/mm3
- Platelets \>100,000/mm3 unless due to lymphoma
- Aspartate Transaminase (AST), Alanine Aminotransferase (ALT) and Alkaline phosphatase \< 3x the upper limit of normal
- Eastern Cooperative Oncology Group (ECOG) performance status of 1, 2, 3
- No prior therapy for the FL or MZL including chemotherapy, single agent rituximab and radiation therapy
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
You may not qualify if:
- Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 5), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Patient has hypersensitivity to boron or mannitol.
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient has received other investigational drugs with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- History of HIV infection (testing not required)
- Concurrent or previous malignancy whose prognosis is poor (\< 90% probability of survival at 5 years) or those who are actively being treated for a second malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early due to lack of funding. All patients were removed from the study.
Results Point of Contact
- Title
- Denise Pereira MD
- Organization
- UM/Sylvester Comprehensive Cancer
Study Officials
- PRINCIPAL INVESTIGATOR
Denise Pereira, MD
University of Miami Sylvester Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 12, 2008
First Posted
October 15, 2008
Study Start
September 25, 2009
Primary Completion
December 1, 2010
Study Completion
February 1, 2011
Last Updated
December 11, 2017
Results First Posted
February 21, 2013
Record last verified: 2017-11