Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma
A Phase II Trial of Bendamustine in Combination With Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma
2 other identifiers
interventional
23
1 country
7
Brief Summary
The purpose of this research study is to learn about the safety of the treatment with a combination of bendamustine and rituximab and to find out what effects, both good and bad this treatment has on DLBCL. In addition to learning about the combination of bendamustine and rituximab, the researchers are interested in learning about how this cancer treatment affects daily activities. Subjects will be asked to complete a Geriatric Assessment (GA). GAs are designed to gather information on memory, nutritional status, mental health, and level of social support. GAs are also designed to help the health care team understand how well subjects can carry out their day to day activities and to briefly describe what other medical conditions subjects may have. This assessment will help the health care team understand a subject's "functional age" (the age a subject functions at) as compared to a subject's actual age. The researchers also want to learn how chemotherapy affects the aging process in our bodies. This is done by measuring the amount of p16 in blood. Researchers want to understand if chemotherapy changes the levels of p16 in blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2011
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2010
CompletedFirst Posted
Study publicly available on registry
November 4, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
April 26, 2017
CompletedMay 24, 2017
April 1, 2017
2.8 years
November 2, 2010
February 17, 2017
April 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Response (CR) Rate as Defined by The International Harmonization Project for Response Criteria
Complete response (CR) is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. The complete response rate is the percentage of participants achieving a CR.
2 years
Secondary Outcomes (5)
Overall Response Rate (ORR)
2 years
Partial Response Rate
2 years
Estimate of Progression-Free Survival
2 years with the median follow-up of 29 months
Overall Survival
2 years with the median follow-up of 29 months
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
Study Arms (1)
Bendamustine, Rituximab
EXPERIMENTALThis is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.
Interventions
Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
Eligibility Criteria
You may qualify if:
- Patients with previously untreated , histologically confirmed, diffuse large B-cell lymphoma (DLBCL), immunophenotyped for CD20
- Age greater than or equal to 65 years
- Stage II-IV
- Measurable disease including lesions that can be accurately measured in 2 dimensions by CT and have a greatest transverse diameter of 1cm or greater, and/or by bone marrow histopathology.
- ECOG performance status of 0-3
- Deemed poor candidate for CHOP-R due to ejection fraction less than or equal to 45%, ECOG performance status of 2, or in the opinion of the treating physician, patient would not tolerate administration of CHOP-R chemotherapy for other reasons,
- Life expectancy of at least 3 months;
- Documented negative serologic testing for HIV, Hepatitis B (unless positive due to prior vaccination), and hepatitis C within the year prior to enrollment
- Adequate bone marrow function (without transfusion support within one week of screening) function:
- Hemoglobin \> 8 g/dL
- Absolute neutrophil count (ANC) \>1000 cells/mm3
- Platelet count \> 75,000/mm3
- Adequate hepatic and renal function as demonstrated by:
- Aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (ULN)
- Total serum bilirubin \< 2.5 x ULN
- +3 more criteria
You may not qualify if:
- Central nervous system involvement by lymphoma
- History of previous allergic reactions to compounds of similar biological or chemical composition as rituximab or bendamustine
- Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective.
- Other active malignancies (except: non-melanoma skin cancer, cervical carcinoma in situ without evidence of disease, prostatic intraepithelial neoplasia without evidence of prostate cancer)
- Patients on strong inhibitors of CYP1A2.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNC Lineberger Comprehensive Cancer Centerlead
- Cephaloncollaborator
Study Sites (7)
Seby B. Jones Cancer Center
Boone, North Carolina, 28607, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Northeast Medical Center
Concord, North Carolina, 28025, United States
Moses Cone Regional Cancer Center
Greensboro, North Carolina, 27403, United States
Leo Jenkins Cancer Center, East Carolina University Medical Center
Greenville, North Carolina, 27834, United States
Rex Healthcare
Raleigh, North Carolina, 27607, United States
Marion L. Shepard Cancer Center
Washington, North Carolina, 27889, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The planned interim analysis was designed for futility (if ORR is less than 13/23 patients). It passed the futility criteria, but based on the survival rate at the time of interim analysis, the investigators decided to terminate the trial.
Results Point of Contact
- Title
- Robin V. Johnson
- Organization
- UNC Lineberger Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Park, MD
University of North Carolina, Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- 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
November 2, 2010
First Posted
November 4, 2010
Study Start
March 1, 2011
Primary Completion
December 1, 2013
Study Completion
August 1, 2016
Last Updated
May 24, 2017
Results First Posted
April 26, 2017
Record last verified: 2017-04