- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01029730
Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma
July 20, 2016 updated by: SCRI Development Innovations, LLC
Phase II Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma
The goal of this multi-center Phase II study is to add bortezomib to the highly active regimen of bendamustine and rituximab.
In this study, bortezomib will be administered on a weekly schedule (Days 1, 8, 15) and will be added to bendamustine/rituximab given in 4-week cycles.
This combination uses the standard bendamustine dosing schedule, and is more convenient than the 5-week regimen of these 3 drugs currently being studied.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Jonesboro, Arkansas, United States, 72401
- NEA Baptist Clinic
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Florida
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Ft. Lauderdale, Florida, United States, 33308
- Holy Cross Hospital
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Ft. Myers, Florida, United States, 33916
- Florida Cancer Specialists
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Georgia
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Gainesville, Georgia, United States, 30501
- Northeast Georgia Medical Center
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Illinois
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Skokie, Illinois, United States, 60076
- Hematology Oncology of the North Shore
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Indiana
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Terre Haute, Indiana, United States, 47802
- Providence Medical Group
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Kentucky
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Louisville, Kentucky, United States, 40207
- Baptist Hospital East
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Louisiana
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Baton Rouge, Louisiana, United States, 70806
- Hematology Oncology Clinic, LLP
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Maryland
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Bethesda, Maryland, United States, 20817
- Center for Cancer and Blood Disorders
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Bethesda, Maryland, United States, 20817
- National Capital Clinical Research Consortium
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Grand Rapids Clinical Oncology Program
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Missouri
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Chesterfield, Missouri, United States, 63017
- St. Louis Cancer Care
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New Hampshire
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Portsmouth, New Hampshire, United States, 03801
- Portsmouth Regional Hospital
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New Jersey
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Morristown, New Jersey, United States, 07960
- Hematology-Oncology Associates of Northern NJ
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Ohio
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Cincinnati, Ohio, United States, 45242
- Oncology Hematology Care
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Oklahoma
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Lawton, Oklahoma, United States, 73505
- Cancer Centers of Southwest Oklahoma
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Oncology Hematology Associates
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Nashville, Tennessee, United States, 37023
- Tennessee Oncology, PLLC
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Texas
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Fort Worth, Texas, United States, 76104
- The Center for Cancer and Blood Disorders
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West Virginia
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Wheeling, West Virginia, United States, 26003
- Schiffler Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Histologically-confirmed indolent lymphoma by the World Health Organization (WHO) classification. The biopsy must fulfill one of the following criteria:
- Follicular lymphoma, grade 1 or 2
- Marginal zone lymphoma
- Small lymphocytic lymphoma (circulating lymphocyte count must be <5,000)
- Lymphoplasmacytic lymphoma
At least one of the following criteria must be met:
- Presence of any symptoms related to lymphoma. These can include classic B-symptoms (fever [>38°C] of unclear etiology, night sweats, weight loss of greater than 10% within the prior 6 months) or other lymphoma-related symptoms (fatigue, pain, etc.).
- Large tumor mass (bulky disease) characterized by lymphomas with a diameter of more than 3 cm in three or more regions or by a lymphoma with a diameter >7 cm in one region
- Presence of lymphoma-related complications, including narrowing of ureters or bile ducts, tumor-related compression of a vital organ, lymphoma-induced pain, cytopenias related to lymphoma/leukemia, splenomegaly, pleural effusions, or ascites
- Hyperviscosity syndrome due to monoclonal gammopathy
- The lymph node biopsy or other lymphoma pathology specimen has CD20+ B-cells.
- Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease.
- No previous systemic treatment for lymphoma. Patients may have had a single course of radiation therapy to a limited field (i.e., not exceeding two adjacent lymph node regions).
- The patient has bidimensionally measurable disease with at least 1 lesion measuring ≥2.0 cm in a single dimension, and the field was not previously radiated.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
Adequate hematologic function ≤7 days prior to start of study treatment:
- Hemoglobin ≥10.0 g/dl
- Absolute neutrophil count (ANC) ≥1000/µL
- Platelet count ≥75,000/µL. If low counts are attributable to bone marrow infiltration or hypersplenism due to lymphoma, ANC must be ≥750/µL and platelets ≥50,000/µL.
- Calculated or measured creatinine clearance ≥30 mL/min ≤7 days of study enrollment (using Cockcroft-Gault method).
- Adequate hepatic function (≤2.5 x upper limit of normal [ULN] for alanine aminotransferase [ALT], aspartate aminotransferase [AST], and alkaline phosphatase and total bilirubin within normal limits).
- Patients must be ≥18 years of age.
- Women of childbearing potential must agree to use a medically acceptable method of birth control (e.g., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 12 months after their last dose of rituximab. Men must use an acceptable method/form of contraception for the duration of treatment and for 3 months after the end of treatment.
- Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
Exclusion Criteria:
- The patient has chronic lymphocytic leukemia.
- The patient has transformed lymphoma.
- History of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma.
- The patient has received corticosteroids for treatment of lymphoma. Chronic, low-dose corticosteroids (e.g., prednisone ≤20 mg/day) are allowed for treatment uses other than lymphoma or complications of lymphoma.
- Peripheral neuropathy ≥ CTCAE v3.0 grade 2, ≤14 days of study enrollment.
- Myocardial infarction ≤6 months prior to study enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, ECG abnormalities at screening must be documented as not medically relevant.
- History of solid organ transplantation, or post-transplant lymphoproliferative disorder.
- Patients with known history of hepatitis B or hepatitis C infection. Hepatitis B surface antigen must be tested.
- The patient has known human immunodeficiency virus (HIV) infection.
- Active, clinically serious infection > grade 2. Patients may be eligible upon resolution of the infection.
- Female patient is pregnant or breast-feeding. Confirmation that female patients of childbearing potential are not pregnant must be established by a negative serum pregnancy test ≤7 days prior to the start of treatment.
- Known hypersensitivity to bendamustine, bortezomib, boron, mannitol, or rituximab.
- Concomitant active malignancy requiring therapy.
- Diagnosis or treatment for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- Treatment with other investigational agents ≤14 days prior to study enrollment.
- Any other disease(s), psychiatric condition, metabolic dysfunction, or findings from a physical examination or clinical laboratory test result that would cause reasonable suspicion of a disease or condition, that contraindicates the use of study drugs, that may increase the risk associated with study participation, that may affect the interpretation of the results, or that would make the patient inappropriate for this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Bendamustine/Bortezomib/Rituximab
Treatment for all patients will be given in cycles of 28 days (4 weeks).
All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles.
Rituximab should be administered first.
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Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Other Names:
Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Other Names:
Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response Rate
Time Frame: 18 months
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Percentage of patients experiencing a complete response (CR) per RECIST.
CR = disappearance of all target lesions.
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate
Time Frame: At 3 and 6 months during treatment, then 6 months post-treatment.
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The Percentage of Patients Who Experience an Objective Benefit From Treatment.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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At 3 and 6 months during treatment, then 6 months post-treatment.
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Median Progression-free Survival
Time Frame: at 3 and 6 months, then every 3 months post-treatment for 1 year and every 6 months thereafter until disease progression; projected 2 years.
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The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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at 3 and 6 months, then every 3 months post-treatment for 1 year and every 6 months thereafter until disease progression; projected 2 years.
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Number of Participants With Adverse Events as a Measure of Safety.
Time Frame: Days 1,8, and 15 of each 28-day cycle for 6 months, then every 3 months for a year, projected 2 years.
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Toxicity grades will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.
Includes adverse events occurring in >1 patient
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Days 1,8, and 15 of each 28-day cycle for 6 months, then every 3 months for a year, projected 2 years.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ian W. Flinn, MD, PhD, SCRI Development Innovations, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (ACTUAL)
October 1, 2014
Study Completion (ACTUAL)
July 1, 2016
Study Registration Dates
First Submitted
December 8, 2009
First Submitted That Met QC Criteria
December 9, 2009
First Posted (ESTIMATE)
December 10, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 19, 2016
Last Update Submitted That Met QC Criteria
July 20, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Immunological
- Bendamustine Hydrochloride
- Rituximab
- Bortezomib
Other Study ID Numbers
- SCRI LYM 66
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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