Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL
A Phase II Trial of Combination Bortezomib and Rituximab as Front-line Therapy for Low-grade Non-Hodgkin's Lymphoma
2 other identifiers
interventional
42
1 country
4
Brief Summary
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 cancer. 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. Giving bortezomib together with rituximab may kill more cancer cells. This phase II trial is studying how well giving bortezomib together with rituximab works as first-line therapy in treating patients with low-grade B-cell non-Hodgkin's lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2006
Longer than P75 for phase_2
4 active sites
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
Study Start
First participant enrolled
August 9, 2006
CompletedFirst Submitted
Initial submission to the registry
August 24, 2006
CompletedFirst Posted
Study publicly available on registry
August 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2014
CompletedResults Posted
Study results publicly available
October 23, 2018
CompletedSeptember 6, 2019
October 1, 2018
5.8 years
August 24, 2006
August 20, 2018
August 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (Complete Response and Partial Response) After Three Inductions Cycles of Treatment.
The primary objective of this study is to assess the overall response rate. Overall response rate at this time point will be defined as complete response \[CR\] plus partial response \[PR\]) after 3 cycles of bortezomib/rituximab induction therapy for patients with previously untreated low-grade, B-cell NHL. Complete response requires 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 (e.g., lactate dehydrogenase \[LDH\]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present). Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen.
At baseline and at the completion of 3 cycles of treatment where 1 cycle equals 35 days.
Secondary Outcomes (8)
Overall Response Rate After 1 Course of Induction Therapy
At baseline and at the completion of cycle 1 (1 cycle =35 days)
Overall Response Rate After Completion of Maintenance Therapy
At baseline and every 2 months during treatment of up to 3 cycles of induction (1 cycle =35days) and 4 cycles of maintenance (1 cycle =2 months) for up to 12 months.
Duration of Overall Response
Every 2 months for up to 12 months then every 6 months for 2 years and annually for 1 year
Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment
Day 1 of each cycle and at the completion of cycles 1 and 3, during treatment up to 12 months
Tissue Evaluation
At baseline and at response assessment 1 after induction part A, 2, after induction part B and 3, maintenance period.
- +3 more secondary outcomes
Study Arms (1)
Bortezomib and Rituximab
EXPERIMENTALOn days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
Interventions
On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
Eligibility Criteria
You may qualify if:
- Histologically confirmed low-grade B-lymphocyte non-Hodgkins lymphoma
- Life expectancy \> 12 months
You may not qualify if:
- No known history of HIV infection
- No other active infection
- No peripheral neuropathy ≥ grade 2 within the past 14 days
- No uncontrolled hypertension
- None of the following cardiac conditions:
- Myocardial infarction within the past 6 months
- No heart failure
- Uncontrolled angina
- Severe uncontrolled ventricular arrhythmias
- Electrocardiographic evidence of acute ischemia
- Active conduction system abnormalities
- No serious medical or psychiatric illness that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- Robert H. Lurie Cancer Centercollaborator
Study Sites (4)
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136, United States
Hematology-Oncology Associates of Illinois
Chicago, Illinois, 60611-2998, United States
Northwestern University
Chicago, Illinois, 60611, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497, United States
Related Publications (1)
Evens AM, Smith MR, Lossos IS, Helenowski I, Millenson M, Winter JN, Rosen ST, Gordon LI. Frontline bortezomib and rituximab for the treatment of newly diagnosed high tumour burden indolent non-Hodgkin lymphoma: a multicentre phase II study. Br J Haematol. 2014 Aug;166(4):514-20. doi: 10.1111/bjh.12915. Epub 2014 Apr 25.
PMID: 24761968DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Leo Gordon, MD
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew M. Evens, DO, MS
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2006
First Posted
August 29, 2006
Study Start
August 9, 2006
Primary Completion
May 22, 2012
Study Completion
October 10, 2014
Last Updated
September 6, 2019
Results First Posted
October 23, 2018
Record last verified: 2018-10